pharmaceutical CV

Hounslow, West London


  • pharmaceutical

    Eisai



    Personal Details
    Telephone Number:   View Contact Details
    City:   Hounslow
    County:   West London
    Desired job title:   pharmaceutical
    Location:   Hounslow West London
    Languages:  
    Added On:   about 7 months ago

    Internal

    More...

    Industries

    Healthcare IT Scientific Senior Management medicine

    Job Titles

    Graphic Web Designer SAP Consultant Biologist Zoological Research Assistant Clinical Research Nurse Chemist Senior Management Quality Control Manager eTMF Document Quality Specialist Expert eTMF Business Process Analyst Business Process Analyst TMF & Contract Specialist eTMF Implementation Business Process Analyst

    Skills

    Oncology Neurology Line Management global stakeholder management new implementation Clinical Operations eTMF Maintenance Quality Assurance Compliance develop new processes formal and informal testing UAT testing and implementation Prince 2 Practitioner Pharmacovigilance CAPA Technical Writing Adverse Events Analytics Cascading Style Sheets Data Mapping Livelink User Acceptance Testing Breast Cancer Suspected Unexpected Serious Adverse Reactions Agile Methodology develop Test documents eTMF design Ariba Test Cases

    Qualifications

    Healthcare, Nursing & Medical Pharmaceutical Master of Business Administration Master of Science COPD and Muscular Dystrophy studies Bachelor of Computer Sciences System Modelling Techniques Bachelor of Computer Sciences UML Bachelor of Science Pharmacology Clinical Trial Pharmaceutical & Scientific A Levels Business Studies Biology Chemistry GCSE

    Employment History

    pharmaceutical

    2019 - Present

    Eisai - Eisai is a global leading research-based pharmaceutical company working in the neurology and oncology therapeutic areas ------- TMF Senior Manager (Perm) * Line management of an associate - creating communication plan, approve holidays, Performance and Development Review * Task allocation for wider global team * Working with EDMS, Regulatory Tracking, and eTMF business owners to ensure inspection readiness strategy * Analysis of TMF for multiple studies * Analysing CAPAs from previous joint FDA/MHRA Inspection * Vendor management and global stakeholder management * Ensuring ``buy in'' from various departments in line with the new TMF vision * Travel to New Jersey to meet global team * RFI- for new TMF system - as SaaS - Veeva Vault * CSV validation plan for new implementation of eTMF * Approving invoices for vendor * Analysing department budget, organistaion charts MS Visio, Planning Project road maps using Ms Project * Undertook internal Management and Business Psychology courses.


    Quality Control Manager

    2017 - 2019

    18 months - Novartis ------- Role - Trial Master File (TMF) Novartis - Basel Switzerland Novartis International is a Swiss multinational pharmaceutical company based in Basel, Switzerland & is one of the largest pharmaceutical companies in the world Trial Master File (TMF) Quality Control Manager (Freelance) ------- * Lead Global meetings with clinical trial directors/managers/CRA/Clinical operations on daily or weekly basis * Participate in vendor training and weekly vendor meetings * Ensuring the highest possible inspection readiness, quality checks, compliance are met using a risk-based approach. * Working with MHRA inspection findings to oversee eTMF Maintenance and Compliance globally * Contributing to risk-based methodology and creation of guidance documents * Creating new Macros and tools in excel and metrics trackers * Developing and Reviewing Work Processes/Sop * Checking processes and Quality Assurance, Capturing CAPA and SOP deviations for QA on AWQA Trackwise QMS systems * Using many CTMS and DMS inline with eTMF and project requirements * Collaborating with colleagues to develop new processes and check system functionalities within budget and scope. * Creating business cases, checking functionalities and generating new ideas collecting URS for new tools and working with developers and vendors * Contributing to implementation of new eTMF system * Developing SharePoint based dashboard to capture Quality issues * Training and providing oversight to Vendors and stake holders (where English is not the first Language) * Business verification CSV, PQ scripts, UAT testing and implementation of customised documentum D2 TMF system - formal and informal testing, dry runs * SME for eTRAC system, and providing access via ticketing system * Working with GXP validated systems * Point of contact for clinical teams and vendors - eTMF, eTRAC, Comp


    TMF & Contract Specialist

    2016 - 2016

    BioMarin is a world leader in developing and commercializing innovative biopharmaceuticals for rare diseases driven by genetic causes ------- * Remapping legacy TMF with in a LiveLink system * Electronic & Paper Reconciliation * Flagging outstanding contracts using SAP (Ariba)


    eTMF Business Process Analyst

    2015 - 2016

    7 months -Role - eTMF Business Process Analyst- Subject Matter Expert (Freelance) Subject Matter Expert (Freelance) GlaxoSmithKline are dedicated to improving the quality of human life by enabling people to do more, feel better, live longer. * Working with the Director of Change Management * eTMF Implementation Business Process Analyst & Subject Matter Expert * Working on Change Management projects utilising CAPA's and RAID logs from previous MHRA eTMF inspections in a matrix environment * Developing, consolidating and innovating eTMF process internationally across 44 systems for all stakeholders to use * Mapping current process issues to create more streamlined processes * Consulting with Admins, system owners, directors and modelling business requirements to desired outcome * Technical writing- Authoring SOP's topic guides on the eTMF functions, QC, maintenance, and role specific guides for Study Managers, CIL, CSS, CTA * Daily use Sharepoint and team sites. * Creating presentations, manuals, and training materials for mock MHRA inspectors * Develop Quality framework for the successful implementation of the eTMF globally * Providing reports and metrics for Directors- tracking of projects, and presenting research. * Contributing to workshops and blended learning approaches to bring about change and train colleagues using Agile methodologies on new systems and processes * CSV - UAT testing of eTMF functionality (Use Case, Writing Test Cases) * Working with developers to implement new eTMF and link to other repositories * Process Diagrams using PowerPoint and Visio * Gap Risk Analysis, RAID Logs and RACI Diagrams * Working with colleagues internationally to Review & Develop SOPS, procedures & Guidelines for the use of the new eTMF and Pharma R&D department * Contribute to eTMF design and provide training to vital functional groups within G


    eTMF Document Quality Specialist

    2015 - 2015

    Phlexglobal are pioneers in the field of electronic Trial Master File (eTMF) document management systems ------- * Transcribing vital information from AESI - (Adverse events of special interests) into sponsor trackers, specifically formatted and ordered to sponsors requirements * eTMF tracking and Meta data re indexing, including raising queried and solving queries * Prep QC and validation of eTMF * Achievement: hand picked by operations manager to work on eTMF study across sites, to Prep, index, and QC eTMF based on DIA Reference model. QCing upto 400 documents a day.


    eTMF Document Quality Specialist

    2015 - 2015

    Quintiles applies the breadth and depth of our service offerings along with extensive therapeutic, scientific and analytics expertise ------- * Meta Data mapping of entire paper TMF and content check * Raising deviations for sponsor using data transmittal form * Working on Breast cancer Basal Carcinoma Oncology Multinational Study * Translation of documents in Greek, German, Polish, Italian, Arabic, Mandarin * Updating trackers for sponsors


    eTMF Document Quality Specialist

    2014 - 2016

    Phlexglobal are pioneers in the field of electronic Trial Master File (eTMF) document management systems ------- * 100% QC review of Pharmacovigilance and Drug safety reporting documents both paper and electronic TMF * Lupus and oncology studies * Working in a team of 3 to manage and track documents, Submissions, AoR, and CIOMS receipts in accordance to ICH GCP, remapping according to DIA ref model * Achievement: By keeping open lines of communication with sponsor I helped to create a tracker with all the possible queries and resolutions to clarify the actions on each document.


    eTMF Document Quality Specialist

    2014 - 2015

    Phlexglobal are pioneers in the field of electronic Trial Master File (eTMF) document management systems ------- * Pharmacovigilance and Drug safety reporting * Managing Drug safety data from multinational sites including translation of documents from asia pacific and European regions. * Worked on MS, COPD and Muscular Dystrophy studies * QC, tracking and updating TMF and eTMF, Cross referencing PI list to sites * eTMF cross checking, Metadata QC, IRC/IEC approvals and submission QC * PSV, SIV, MVR, COV, Monitoring Logs, QC of reports and EC Approval, not limited to ICF and IB, FFD, FDD 1572 and Medical Licence (USA), Delegation cross checks * Updating eTMF using Phlexeview, Nextdocs and Exostar * eTMF/TMF remapping- meta data QC * QC of CIOMS reports, Drug Safety Pharmacovigilance reports, SAE reporting Documents, Monitoring plan, CEC, LECS, Moh, Central/Local IBR, IEC, SUSAR forms, submission and resubmission forms, GAP packs. All forms related to TMF * Achievement: Helped to develop Test documents, instructions and checklists for the company to use during the QC process. 95% pass on selection interview test consisting of GCP, TMF, Data entry speed and QC of complex alphanumeric data


    Data Manager

    2014 - 2014

    Chiltern is the leading, global mid-sized contract research organization Clinical Data Associate 1/ Data Manager ------- * Managing data from multinational sites, on Liver cancer Oncology and MS studies * QC tracking and updating CRF forms using Data Clarification forms * Data validation, referring to data input guidelines and data management plan. * Translating CRF during QC stage (Serbian, Czech, Polish, Italian and Spanish) * Updating Datalabs, and Inform 5.5 Clinical Oracle databases, Solving queries in MediData Rave * Maintain clear communication with Data lead and Senior Data manager for the timely and accurate management of CRF QC, transcription, database update and deviation reporting, CDISC meetings data base lock end of study protocols * Achievement: Having joined the company from the fast paced environment of Retroscreen my strong work ethic and will to work accurately I helped to QC and arrange over 200 CRF files with in a 2 week period.


    Manager

    2013 - 2014

    / in house Monitor * Collating clinical data received from Clinical studies ------- * To serve as contact for project teams * To assist monitors with running reports, QC of documents and data, and flag data out of range as indicated in protocol * Cleaning data from all clinical trial sites with monitors including review of CRF forms- source data Review/Verification * Ensuring colleagues have countersigned documents work in accordance to the protocol * Involved in data management plan meetings and Data base lock out CDISC meetings, monitoring plan meetings. * Clinical Ink and MediData RAVE. * CSV, UAT testing, Data validation of EDC system. * Data manipulations in SAS, Solving queries in MediData Rave * Writing SOP's for new procedures and QC of cross department SOP's * Including completeness, consistency, accuracy and evaluation or protocol deviations while maintaining communication with Senior QC manager and Senior Monitors * Preparing clinical trial data for PI meeting with sponsors in excel * Liaising with appropriate staff to action resolution to queries for fast turn around before data base lock. * Point of contact for publications data manipulations with S-Cubed Data management company. * Data handling using Electronic Data Capture (EDC) and Case Report Forms (CRF). * Achievement: As a direct result of my scientific interest and warm approach, I am fortunate enough to be working alongside Robert Lambkin-Williams (CEO) on a carrying out data manipulation for major publications on the Brisbane Virus strain of Influenza. Gained many training certificates including, SOP writing, Medidata study coordinator Rave Training, Clinical Ink portal/tablet training for coordinators, Infection control, MHRA inspection preparation, GCP refresher & ICH E6 GCP, Health & safety, QA induction,


    Data Manager

    2013 - 2014


    Clinical Trials Administrator

    2012 - 2013

    Retroscreen Virology Ltd. ------- Leading Virology Research Site and CRO (Clinical Trials Unit) * Gathering all trial data, such as ECGs, Spirometry results, temperature readings and symptom diary cards, scanning them and sending to the Data Managers * Data entry of Analytical Results Forms (ARF) * Collation of the Trial Master File (TMF) * CO-Monitoring on site visits to * Writing Of SOP's, Usage of specialist software: Med+DBase, InstemAlphadas, and Clinical Ink. * Prepare, review and submit submissions to Regulatory agencies * Collate regulatory correspondence * Regular travel to new site in Bourn (Cambridge) to set up the study administration * Providing vital link between the Screening Admin team and the Physicians, regarding constantly changing lists of volunteers taking part. * TMF collation, site file and trial level documents QC in accordance to ICH GCP. * Creation, Distribution and QC of all Documents at Investigator Site * Tracking, organising and controlling CFR and Trials files * Point of contact for all clinical staff and external monitors wanting access to clinical files * Point of contact for volunteers who are invited for screening procedures * Point of contact for PI's for all forms, files and information regarding the location of paper and electronic documents. * Maintain clear communication with PI and ensure proper management of trial files from site initiation to close out. * Participating in Physician and Monitoring meetings to design work flow system and monitoring plan responsibilities in a multidisciplinary department. * Achievement: Joined at a time of rapid growth and reorganisation. In this highly pressurized environment, I identified ways to streamline processes in many areas, and through my strong interpersonal skills with Study Leaders and Physicians, brought about positive changes that remain in existence.


    2012 - 2014


    Clinical Trials Administrator

    2012 - 2013


    Stem Cell assistant Scientist

    2011 - 2012

    Precious Cells International ------- Precious Cells are the UK's premium provider of stem cell As it was a small start up company, my role was twofold: * Had sole responsibility for all marketing activities. Worked side by side with the CEO on strategy and planning, Analysing and translating business requirements into flow diagrams and technical design * Designed roller banners and marketing material for the exhibitions, liaised with design agency to deliver them on time and on budget. * Gathered leads from exhibitions and subsequently conducted outbound telesales calls to prospective clients. These were B2C, extremely consultative in nature, and would often go on for an hour or more. The aim was to get our name out there, and increase public relations and awareness. We dealt with some high profile celebrity clients. * Liaised with leading marketing solutions provider Harte-Hanks to optimise and develop the scripts for a B2B telemarketing campaign with leads generated from the Dentistry Show. * Presenting Business development ideas to dentists. * Day to day usage of CRM software (Salesforce). * Kept up to date with current advances in stem cell technologies with company journal club * Achievement: Successfully organised attendance at 2 very high profile exhibitions at Earl's Court and the NEC: The Dentistry Show (B2B) and The Baby Show (B2C). Assistant Scientist (30%) * Handling umbilical cord blood and tissue samples within a level B cleanroom laboratory environment. * Extracting, Processing and storing stem cells using cryoprotectants * Cell counting and cell sorting using Flow Cytometry. * Daily calibration of HEPA Filters, monitoring of nitrogen tanks and dewars, and other laboratory equipment. * Liaising with Phlebotomists and patients to organise prompt delivery of stem cells from the delivery ward. * Achievement: Was trained by Beckman Coulter on the Sepax 2


    Temporary sales

    2010 - 2011

    Temporary sales roles -CarPhone Warehouse, Ladbrokes,


    Sterile Services Technician

    2009 - 2009

    West Middlesex University Hospital ------- The West Middlesex University Hospital is an award-winning busy urban acute hospital based near * Complete removal of blood, bone and biological material from surgical equipment utilising HEMO52 enzyme cleaning products. * Cleaning, auto-washing, autoclaving and packing surgical equipment. * Bar-coding and scanning surgical equipment for location purposes. * All carried out in strict adherence to Standard Operating Procedures (SOPs) and Good Clinical Practice (GCP). * Achievement: Gained excellent understanding of the importance of GCP in a healthcare environment and level B clean room protocol.


    Patient Recruitment Associate

    2005 - 2006

    Richmond Pharmacology Ltd ------- Richmond Pharmacology is the UK's leading Clinical Research Organisation Patient Recruitment Associate (Part - time whilst at University) * Working to KPI's Making a high volume of calls with the aim to recruit volunteers for phase 1 & 2 clinical trials within the therapeutic areas of Diabetes and NSAIDs. * Co-ordinated medical screenings by liaising with GPs, PI's, Project Managers and volunteers, Processing payments for volunteers. * Running through Exclusion, Inclusion criteria, for current trials including Conmeds, Medical History, (mental health, gastro intestinal, allergies, dermatological, respiratory, family medical history etc) to record suitability for trials. * Achievement: Consecutively exceeded recruitment targets of arranging 20 appointments per shift.


    Education History

    Name of Institution: Westminster University

    Education Title: Prince 2 Foundation & Practitioner


    - 2015

    Institute Location: , Utrecht, , NL

    Description: Clinical Research CRA Monitoring Utrecht University Netherlands


    - 2019

    Institute Location: , Basel, , CH


    Education Title: GCSE


    Education Title: A Levels

    Major: Biology, Chemistry, Business Studies


    - 2013

    Name of Institution: Royal College of Physicians

    Education Title: some college


    Name of Institution: Institute Of Clinical Research

    Institute Location: , , , QA

    Education Title: Bachelor of Computer Sciences

    Major: UML, System Modelling Techniques


    2005 - 2009

    Name of Institution: Kingston University

    Education Title: Bachelor of Science

    Major: Pharmacology

    Description: Project: Anticholinergic Effects of Viburnum Opulus Bark on Isolated Guinea Pig Ileum. Achievement: Throughout my degree my strength was in the lab - consistently scoring over 70% in every lab report.


    Name of Institution: University of London

    Education Title: Master of Business Administration


    Hobbies & Interest

    EXTRACURRICULAR ACTIVITIES I undertake voluntary work for the homeless, have performed music in the Royal Albert Hall and around Europe, and I have an avid interest in the stock market, business and entrepreneurship. References are available on request


    Personality Assessment data not available!


    pharmaceutical CV Profile

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    PERSONAL PROFILE

     

    A Pharmacology graduate, with 7 years experience of working within both scientific and commercial environment in both public/private CRO’s and Pharma companies. Self motivated, confident, mature, and with a logical and inquisitive mind. I am able to think around problems in a rational way, and communicate these effectively with colleagues and clients alike. I have a keen eye for structure, design and data collection, as proven by my success in various roles where meticulous attention to detail was paramount. Through my excellent organisational skills, and never shying away from the task in hand, I have always exceeded what is expected of me. With CTA, In-house Monitoring/Data Management, and extensive eTMF experience, I am looking for an opportunity to build on my current skill-set within the Pharmaceutical industry, Ideally as a Business/system analyst, Project Manager or Minotor/CRA.

     

     

    Professional Training

     

    Date

    Course

    Institution

    present

    Prince 2 Foundation & Practitioner

    Westminster University

    Feb

    2019

    A1.1 German (learning)

    ECAP Basel

    May

    2016

    GCP Principles

    Institute Of Clinical Research

    Mar

    2016

    BCS UML System Modelling Techniques

    QA

    Jul

    2015

    Clinical Research CRA Monitoring

    Utrecht University Netherlands

    May

    2013

    Clinical Trial Design and Analysis

    Royal College of Physicians

    Jun

    2013

    Mini MBA

    University of London

     

    Professional Events

     

    Date

    Course

    Institution

    Sept 2019

    TMF & GCP Inspection Readiness Brussels

    IQPC

     

     

    WORK HISTORY Summary

     

                    Sept 2019 – Feb 2020                                5 months                                - Eisai

    Role - TMF Senior Manager (Perm)

     

                    August 2017 – Feb 2019                                18 months                                – Novartis

    Role - Trial Master File (TMF) Quality Control Manager

     

                    June 2016 – August 2016                                2 months                                - BioMarin

    Role - TMF & Contract Specialist

     

                    Nov 2014 – June 2016                                7 months                                - PhlexGlobal

    Role - eTMF Document Quality Specialist SME

     

                    Sept 2015 –April 2016                                7 months                                -GlaxoSmithKline

    Role - eTMF Business Process Analyst- Subject Matter Expert (Freelance)

     

                    March 2015 – May 2015                                2 months                                - Quintiles

    Role - eTMF Document Quality Specialist

     

                    August 2014 – November 2014                3 months                - Chiltern International

    Role - Data Manager

     

                    October 2013 – June 2014                                8 months                - Retroscreen Virology

    Role - Data Manager/ inhouse Monitor

     

                    May 2012 – October 2013                                 5 months                - Retroscreen Virology

    Role - Clinical Trials Administrator

     

                    July 2011 – May 2012                10 months                - Precious Cells International

    Role - Stem Cell assistant Scientist

     

                    Sept 2005 - Aug 2006                11 months                - Richmond Pharmacology

    Role - Patient Recruitment Associate

     

     

     

     

    WORK HISTORY

     

    Sept 2019 – Feb 2020                Eisai – Hatfield UK

    Eisai is a global leading research-based pharmaceutical company working in the neurology and oncology therapeutic areas 

     

    TMF Senior Manager (Perm)

                    Line management of an associate – creating communication plan, approve holidays, Performance and Development Review

                    Task allocation for wider global team

                    Working with EDMS, Regulatory Tracking, and eTMF business owners to ensure inspection readiness strategy

                    Analysis of TMF for multiple studies

                    Analysing CAPAs from previous joint FDA/MHRA Inspection

                    Vendor management and global stakeholder management

                    Ensuring “buy in” from various departments in line with the new TMF vision

                    Travel to New Jersey to meet global team

                    RFI- for new TMF system – as SaaS – Veeva Vault

                    CSV validation plan for new implementation of eTMF

                    Approving invoices for vendor

                    Analysing department budget, organistaion charts MS Visio, Planning Project road maps using Ms Project

                    Undertook internal Management and Business Psychology courses.

     

     

    August 2017 – Feb 2019                                Novartis – Basel Switzerland

    Novartis International is a Swiss multinational pharmaceutical company based in BaselSwitzerland & is one of the largest pharmaceutical companies in the world

     

    Trial Master File (TMF) Quality Control Manager (Freelance)

     

                    Lead Global meetings with clinical trial directors/managers/CRA/Clinical operations on daily or weekly basis

                    Participate in vendor training and weekly vendor meetings

                    Ensuring the highest possible inspection readiness, quality checks, compliance are met using a risk-based approach.

                    Working with MHRA inspection findings to oversee eTMF Maintenance and Compliance globally

                    Contributing to risk-based methodology and creation of guidance documents

                    Creating new Macros and tools in excel and metrics trackers

                    Developing and Reviewing Work Processes/Sop

                    Checking processes and Quality Assurance, Capturing CAPA and SOP deviations for QA on AWQA Trackwise QMS systems

                    Using many CTMS and DMS inline with eTMF and project requirements

                    Collaborating with colleagues to develop new processes and check system functionalities within budget and scope.

                    Creating business cases, checking functionalities and generating new ideas collecting URS for new tools and working with developers and vendors

                    Contributing to implementation of new eTMF system

                    Developing SharePoint based dashboard to capture Quality issues

                    Training and providing oversight to Vendors and stake holders (where English is not the first Language)

                    Business verification CSV, PQ scripts, UAT testing and implementation of customised documentum D2 TMF system – formal and informal testing, dry runs

                    SME for eTRAC system, and providing access via ticketing system

                    Working with GXP validated systems

                    Point of contact for clinical teams and vendors – eTMF, eTRAC, Compliance, and encouraging Collaboration

     

    June 2016 – August 2016                                BioMarin

    TMF & Contract Specialist (Freelance)

    BioMarin is a world leader in developing and commercializing innovative biopharmaceuticals for rare diseases driven by genetic causes

     

                    Remapping legacy TMF with in a LiveLink system

                    Electronic & Paper Reconciliation

                    Flagging outstanding contracts using SAP (Ariba)

     

    June 2016 – June 2016                                PhlexGlobal

    eTMF Document Quality Specialist SME (Freelance)

    Phlexglobal are pioneers in the field of electronic Trial Master File (eTMF) document management systems

     

                    100% QC review of Pharmacovigilance and Drug safety reporting documents both paper and electronic TMF

                    Lupus and oncology studies

                    Working in a team of 3 to manage and track documents, Submissions, AoR, and CIOMS receipts in accordance to ICH GCP, remapping according to DIA ref model

     

                    Achievement: By keeping open lines of communication with sponsor I helped to create a tracker with all the possible queries and resolutions to clarify the actions on each document.

     

     

    Sept 2015 –April 2016                                GlaxoSmithKline

    eTMF Business Process Analyst- Subject Matter Expert (Freelance)

    GlaxoSmithKline are dedicated to improving the quality of human life by enabling people to do more, feel better, live longer.

     

                    Working with the Director of Change Management

                    eTMF Implementation Business Process Analyst & Subject Matter Expert

                    Working on Change Management projects utilising CAPA’s and RAID logs from previous MHRA eTMF inspections in a matrix environment

                    Developing, consolidating and innovating eTMF process internationally across 44 systems for all stakeholders to use

                    Mapping current process issues to create more streamlined processes

                    Consulting with Admins, system owners, directors and modelling business requirements to desired outcome

                    Technical writing- Authoring SOP’s topic guides on the eTMF functions, QC, maintenance, and role specific guides for Study Managers, CIL, CSS, CTA

                    Daily use Sharepoint and team sites.

                    Creating presentations, manuals, and training materials for mock MHRA inspectors

                    Develop Quality framework for the successful implementation of the eTMF globally

                    Providing reports and metrics for Directors- tracking of projects, and presenting research.

                    Contributing to workshops and blended learning approaches to bring about change and train colleagues using Agile methodologies on new systems and processes

                    CSV - UAT testing of eTMF functionality (Use Case, Writing Test Cases)

                    Working with developers to implement new eTMF and link to other repositories

                    Process Diagrams using PowerPoint and Visio

                    Gap Risk Analysis, RAID Logs and RACI Diagrams

                    Working with colleagues internationally to Review & Develop SOPS, procedures & Guidelines for the use of the new eTMF and Pharma R&D department

                    Contribute to eTMF design and provide training to vital functional groups within GSK and to external service providers

                    Creating Topic Guides, using structured flow diagrams

                    Contribute to stakeholder reviews

     

                    Achievement: Technical writing skills, created topic user guides from scratch, and used a blended learning method to train colleagues on the functions of the eTMF software.

     

     

    May 2015 – Sept 2015                                PhlexGlobal

    eTMF Document Quality Specialist (Freelance)

    Phlexglobal are pioneers in the field of electronic Trial Master File (eTMF) document management systems

     

                    Transcribing vital information from AESI – (Adverse events of special interests) into sponsor trackers, specifically formatted and ordered to sponsors requirements

                    eTMF tracking and Meta data re indexing, including raising queried and solving queries

                    Prep QC and validation of eTMF

     

                    Achievement: hand picked by operations manager to work on eTMF study across sites, to Prep, index, and QC eTMF based on DIA Reference model. QCing upto 400 documents a day.

    March 2015 – May 2015                                Quintiles

    Quintiles applies the breadth and depth of our service offerings along with extensive therapeutic, scientific and analytics expertise

     

    eTMF Document Quality Specialist (Freelance)

                    Meta Data mapping of entire paper TMF and content check

                    Raising deviations for sponsor using data transmittal form

                    Working on Breast cancer Basal Carcinoma Oncology Multinational Study

                    Translation of documents in Greek, German, Polish, Italian, Arabic, Mandarin

                    Updating trackers for sponsors

     

    November 2014 – January 2015                                PhlexGlobal

    Phlexglobal are pioneers in the field of electronic Trial Master File (eTMF) document management systems

     

    eTMF Document Quality Specialist (Freelance)

                    Pharmacovigilance and Drug safety reporting

                    Managing Drug safety data from multinational sites including translation of documents from asia pacific and European regions.

                    Worked on MS, COPD and Muscular Dystrophy studies

                    QC, tracking and updating TMF and eTMF, Cross referencing PI list to sites

                    eTMF cross checking, Metadata QC, IRC/IEC approvals and submission QC

                    PSV, SIV, MVR, COV, Monitoring Logs, QC of reports and EC Approval, not limited to ICF and IB, FFD, FDD 1572 and Medical Licence (USA), Delegation cross checks

                    Updating eTMF using Phlexeview, Nextdocs and Exostar

                    eTMF/TMF remapping- meta data QC

                    QC of CIOMS reports, Drug Safety Pharmacovigilance reports, SAE reporting Documents, Monitoring plan, CEC, LECS, Moh, Central/Local IBR, IEC, SUSAR forms, submission and resubmission forms, GAP packs.  All forms related to TMF

     

                    Achievement: Helped to develop Test documents, instructions and checklists for the company to use during the QC process. 95% pass on selection interview test consisting of GCP, TMF, Data entry speed and QC of complex alphanumeric data

     

     

    August 2014 – November 2014                                Chiltern International

    Chiltern is the leading, global mid-sized contract research organization

     

    Clinical Data Associate 1/ Data Manager

                    Managing data from multinational sites, on Liver cancer Oncology and MS studies

                    QC tracking and updating CRF forms using Data Clarification forms

                    Data validation, referring to data input guidelines and data management plan.

                    Translating CRF during QC stage (Serbian, Czech, Polish, Italian and Spanish)

                    Updating Datalabs, and Inform 5.5 Clinical Oracle databases, Solving queries in MediData Rave

                    Maintain clear communication with Data lead and Senior Data manager for the timely and accurate management of CRF QC, transcription, database update and deviation reporting, CDISC meetings data base lock end of study protocols

     

                    Achievement: Having joined the company from the fast paced environment of Retroscreen my strong work ethic and will to work accurately I helped to QC and arrange over 200 CRF files with in a 2 week period.

     

    May 2012 – June 2014                                Retroscreen Virology Ltd.

    Leading Virology Research Site and CRO

     

    October 2013 – June 2014

    QC Data Manager/ in house Monitor

                    Collating clinical data received from Clinical studies

                    To serve as contact for project teams

                    To assist monitors with running reports, QC of documents and data, and flag data out of range as indicated in protocol

                    Cleaning data from all clinical trial sites with monitors including review of CRF forms- source data Review/Verification

                    Ensuring colleagues have countersigned documents work in accordance to the protocol

                    Involved in data management plan meetings and Data base lock out CDISC meetings, monitoring plan meetings.

                    Clinical Ink and MediData RAVE.

                    CSV, UAT testing, Data validation of EDC system.

                    Data manipulations in SAS, Solving queries in MediData Rave

                    Writing SOP’s for new procedures and QC of cross department SOP’s

                    Including completeness, consistency, accuracy and evaluation or protocol deviations while maintaining communication with Senior QC manager and Senior Monitors

                    Preparing clinical trial data for PI meeting with sponsors in excel

                    Liaising with appropriate staff to action resolution to queries for fast turn around before data base lock.

                    Point of contact for publications data manipulations with S-Cubed Data management company.

                    Data handling using Electronic Data Capture (EDC) and Case Report Forms (CRF).

     

                    Achievement: As a direct result of my scientific interest and warm approach, I am fortunate enough to be working alongside Robert Lambkin-Williams (CEO) on a carrying out data manipulation for major publications on the Brisbane Virus strain of Influenza. Gained many training certificates including, SOP writing, Medidata study coordinator Rave Training, Clinical Ink portal/tablet training for coordinators, Infection control, MHRA inspection preparation, GCP refresher & ICH E6 GCP, Health & safety, QA induction,  

     

    May 2012 – October 2013                                 Retroscreen Virology Ltd.

    Leading Virology Research Site and CRO

    Clinical Trials Administrator (Clinical Trials Unit)

                    Gathering all trial data, such as ECGs, Spirometry results, temperature readings and symptom diary cards, scanning them and sending to the Data Managers

                    Data entry of Analytical Results Forms (ARF)

                    Collation of the Trial Master File (TMF)

                    CO-Monitoring on site visits to Cambridge- QC of Clinical Data

                    Writing Of SOP’s, Usage of specialist software: Med+DBase, InstemAlphadas, and Clinical Ink.

                    Prepare, review and submit submissions to Regulatory agencies

                    Collate regulatory correspondence

                    Regular travel to new site in Bourn (Cambridge) to set up the study administration

                    Providing vital link between the Screening Admin team and the Physicians, regarding constantly changing lists of volunteers taking part.

                    TMF collation, site file and trial level documents QC in accordance to ICH GCP.

                    Creation, Distribution and QC of all Documents at Investigator Site

                    Tracking, organising and controlling CFR and Trials files

                    Point of contact for all clinical staff and external monitors wanting access to clinical files

                    Point of contact for volunteers who are invited for screening procedures

                    Point of contact for PI’s for all forms, files and information regarding the location of paper and electronic documents.

                    Maintain clear communication with PI and ensure proper management of trial files from site initiation to close out.  

                    Participating in Physician and Monitoring meetings to design work flow system and monitoring plan responsibilities in a multidisciplinary department.

     

                    Achievement: Joined at a time of rapid growth and reorganisation. In this highly pressurized environment, I identified ways to streamline processes in many areas, and through my strong interpersonal skills with Study Leaders and Physicians, brought about positive changes that remain in existence.

                    Creating comprehensive reports using graphs and analysis for managers to present to directors using feedback forms volunteers completed after a trial.  

     

    July 2011 – May 2012                Precious Cells International

    Precious Cells are the UK’s premium provider of stem cell banking services.

    As it was a small start up company, my role was twofold:

     

    Sales &Marketing Executive (70%)

                    Had sole responsibility for all marketing activities. Worked side by side with the CEO on strategy and planning, Analysing and translating business requirements into flow diagrams and technical design

                    Designed roller banners and marketing material for the exhibitions, liaised with design agency to deliver them on time and on budget.

                    Gathered leads from exhibitions and subsequently conducted outbound telesales calls to prospective clients. These were B2C, extremely consultative in nature, and would often go on for an hour or more. The aim was to get our name out there, and increase public relations and awareness. We dealt with some high profile celebrity clients.

                    Liaised with leading marketing solutions provider Harte-Hanks to optimise and develop the scripts for a B2B telemarketing campaign with leads generated from the Dentistry Show.

                    Presenting Business development ideas to dentists.

                    Day to day usage of CRM software (Salesforce).

                    Kept up to date with current advances in stem cell technologies with company journal club

     

                    Achievement: Successfully organised attendance at 2 very high profile exhibitions at Earl’s Court and the NEC: The Dentistry Show (B2B) and The Baby Show (B2C).

     

    Assistant Scientist (30%)

                    Handling umbilical cord blood and tissue samples within a level B cleanroom laboratory environment.

                    Extracting, Processing and storing stem cells using cryoprotectants

                    Cell counting and cell sorting using Flow Cytometry.

                    Daily calibration of HEPA Filters, monitoring of nitrogen tanks and dewars, and other laboratory equipment.

                    Liaising with Phlebotomists and patients to organise prompt delivery of stem cells from the delivery ward.

     

                    Achievement: Was trained by Beckman Coulter on the Sepax 2 (for specialised blood separation)- one of only 2 of these machines in the UK.

     

     

    Jan 2010 - Jul 2011                Temporary sales roles –CarPhone Warehouse, Ladbrokes, BUPA, Harrods

     

    Jul 2009 - Nov 2009                 West Middlesex University Hospital

    The West Middlesex University Hospital is an award-winning busy urban acute hospital based near Twickenham.

    Sterile Services Technician

                    Complete removal of blood, bone and biological material from surgical equipment utilising HEMO52 enzyme cleaning products.

                    Cleaning, auto-washing, autoclaving and packing surgical equipment.

                    Bar-coding and scanning surgical equipment for location purposes.

                    All carried out in strict adherence to Standard Operating Procedures (SOPs) and Good Clinical Practice (GCP).

     

                    Achievement: Gained excellent understanding of the importance of GCP in a healthcare environment and level B clean room protocol.

     

     

     

    Sept 2005 - Aug 2006                Richmond Pharmacology Ltd

    Richmond Pharmacology is the UK’s leading Clinical Research Organisation

    Patient Recruitment Associate  (Part - time whilst at University)

                    Working to KPI’s Making a high volume of calls with the aim to recruit volunteers for phase 1 & 2 clinical trials within the therapeutic areas of Diabetes and NSAIDs.

                    Co-ordinated medical screenings by liaising with GPs, PI’s, Project Managers and volunteers, Processing payments for volunteers.

                    Running through Exclusion, Inclusion criteria, for current trials including Conmeds, Medical History, (mental health, gastro intestinal, allergies, dermatological, respiratory, family medical history etc) to record suitability for trials.

     

                    Achievement: Consecutively exceeded recruitment targets of arranging 20 appointments per shift.

     

    EDUCATION AND QUALIFICATIONS

     

    2005 - 2009                                BSc - Pharmacology

    Kingston University

    Project: Anticholinergic Effects of Viburnum Opulus Bark on Isolated Guinea Pig Ileum.

    Achievement: Throughout my degree my strength was in the lab - consistently scoring over 70% in every lab report.

     

    2004                                                A Levels Biology (C) Chemistry (C) Business Studies (C)

    2002                                                9 GCSEs

     

    EXTRACURRICULAR ACTIVITIES

    I undertake voluntary work for the homeless, have performed music in the Royal Albert Hall and around Europe, and I have an avid interest in the stock market, business and entrepreneurship.

    References are available on request

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