Clinical Trial Manager

Your New Company
Experienced Clinical Trial Manager for Global Pharma, remote based position, must have previous CRA experience - imm start
Acts as Country Study Manager for designated studies as required by the Director of Clinical Operations
Responsible for the local portion of the assigned study and ensuring the effective and efficient delivery of country/region operational aspects in accordance with the study milestones, study specific plans, ICH/GCP standards, Global SOPs, local operating guidelines and local regulatory requirements.
Provides local leadership and oversees site management, patient recruitment, retention, and site closure by CRO local team in the responsible country in collaboration with the Study Leader (SL).
Provides local expertise, knowledge of local regulations and strategic planning to SL for successful overall study delivery and completion.
Provides oversight and guidance to junior trial managers as required
PRINCIPAL ACCOUNTABILITIES:
Develops and maintains effective working relationships with key stakeholders for the management of local aspects.
Works with SL to maintain local oversight of CRO performance and issues resolution/escalation. Identify systematic issues and coordinates any corrective action for the responsible countries/region(s).
Works with SL to maintain tracking of country/region study status, provides regular updates and escalates unresolved issues to SL.
Manages local affiliate study budget.
Builds and maintains a professional relationship, participating in regional/country Investigator Meetings as necessary.
Provides oversight and guidance to other study team members as required
Provides local expertise to ensure operational feasibility and delivery of the overall study
Provides operational input into the development and tracking of study team goals.
Provides content review and input into response to HA queries.
Coordinates responses to study questions or issues from IRBs/ECs.
Develops country/regional level study timelines and ensures that milestones are set and managed for the overall study delivery in association with the SL.
Provides operational input and insight from a country/regional perspective into relevant
study related documentation (including protocol and informed consent form) and processes.
Provides input from a country/regional perspective into study level patient recruitment plan and retention strategies created by CRO and the study team based on site feasibility data.
In collaboration with SL oversees CRO study conduct in the responsible countries/region(s) in line with overall study team plan
In collaboration with SL oversees and/or coordinates CRO local study start up, timelines, close out, resources, site budgets and contracts, HA and EC submissions, risk, quality and site management performance to ensure successful delivery of study goals.
Participate in the review of any relevant management plans by the CRO (Study management plan, monitoring plan, recruitment plan, quality management plan, recruitment plan, safety management plan etc).
Performs ongoing service provider management (e.g., CROs, Central Labs, IV/XRS) and facilitates issue resolution in collaboration with SL.
In collaboration with SL oversees the development and maintenance of study specific documents created by service providers.
Ensures study adherence to ICH/GCP, SOPs and local regulations
Ensures the study is conducted locally in compliance with ICH-GCP guidelines, global and local SOPs, local operating guidelines and all applicable local regulatory requirements.
Oversees CRO to ensure protocol adherence and consistency of study processes and procedures across all investigational sites in his/her responsible region.
Ensures SAE reporting complies with local HA/IRBs regulations.
In collaboration with the SL and where necessary other stakeholders, develops and executes the local implementation of the audit quality and risk management plans identifying critical issues for the Affiliate and ensuring contingencies are established and captured in the study level risk management plan. Ensures that the plans are reviewed and updated over the course of the study.
Ensures the completion and finalization of any corrective and preventative action plans resulting from internal site audits.
Identifies and contributes to areas of best practice and process improvements
Assists Director of Clinical Operations with ensuring processes are aligned with best practice and regulatory requirements
Ideally 2 - 3 years as a Clinical Trial Manager, and previously worked as a CRA,
Out of scope, and remote, immediate start.
Please send CV to #####