Clinical Data Manager

Clinical Data Manager
About Astellas:
At Astellas we are making treatments that matter to people.
We are tackling the toughest health challenges putting the patient at the heart of every move we make.
Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.
We have developed ground-breaking, innovative medicines in immunology, oncology and urology.
Our medicines are extending and saving the lives of cancer patients, making transplantation possible and improving the quality of life for those living with conditions where needs are often overlooked.
We take a patient-focused approach, that allows us to convert brilliant early science into treatments and solutions that directly improve and save patients’ lives.
From lab to clinic to patient, we focus on the most promising science, empower the best talent to pursue it, and develop life-changing solutions alongside the best partners.
About this job:
As part of Astellas Data Science division expansion in the UK, we are looking to recruit Clinical Data Managers at various levels, who will contribute to the day-to-day operations that support Astellas' drug portfolio.
As a Data Manager, you will lead on external data processing in cross-functional clinical study team meetings and provide in-depth knowledge and consultation to the clinical study teams.
You will be responsible for study level data management activities of varying complexity within a drug development program for Data Science, including performing external clinical data processing and reconciliation activities. You may also oversee CRO personnel performing the external clinical data processing and reconciliation tasks. You will also ensure that studies within the program are executed within the agreed timelines and according to the agreed global standards and processes.
This is an exciting opportunity to join a team, that truly encourages and fosters inquisitive and collaborative ways of working. We are looking for driven individuals to bring their ideas and varied experiences of managing and processing external data to this global division.
Key activities are noted below:
Creating and maintaining study-level (external) data transfer specifications
Processing test transfers and working with external data providers to reconcile issues
Defining specifications for reconciliation checks and exception listings to perform external data checks against production data transfers received for data reconciliation.
Receiving production data transfers, reviewing the discrepancy output of reconciliation checks and exception listings, working with Data Management, Study Management, Bioanalysis and/or Stats/Stats Programming and/or external data providers to resolve data discrepancies.
Overseeing or acting as the intermediary between Data Management, Statistical Programming and external data providers regarding external data specifications, data, and technical issues.
Working with data standards subject matter experts to ensure data transfer structures and test codes comply with Astellas' standard data models.
Assisting and providing study-level support to study teams and other team members.
Essential Knowledge & Experience:
Proven experience in managing external clinical data processes for data management. This includes the creation of external data transfer specifications; leading study level UAT and QC of external data transfers and performing reconciliation data checks on external data.
In-depth knowledge of drug development strategy, clinical trial, and data management processes.
Strong understanding of different types of data sources in a clinical trial setting and/or expertise with external data types.
The ability to apply critical thinking to enable judgement-based decisions
The ability to influence study teams and drive decision making.
Demonstrated learning agility such as having adopted new technologies for Data Management.
Preferred Knowledge & Experience:
eClinical Solutions Elluminate is desirable however not essential
Education/Qualifications:
A bachelor's degree or equivalent, gained in a biological science, health-related, or computer science field.
Additional information:
This is a permanent full-time, position based in the UK.
We offer a hybrid working pattern, requiring one day per quarter in the office (Addlestone), blended with a collaborative video environment that supports working from home.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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