External Data Manager

Location

Addlestone, Surrey | United Kingdom

Job description

External Data Manager

About Astellas:

At Astellas we are a progressive health partner, delivering value and outcomes where needed.

We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.

We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.

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 work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes.

Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.

About this job:

As part of our expansion in the UK, we are looking to recruit Data Managers at various levels, to support our day-to-day operations in support of Astellas’s drug portfolio.

You will act as a data management lead for external data processing in cross-functional clinical study team meetings and will provide in-depth knowledge and consultation to the clinical study teams.

You will be responsible for study level data management activities of moderate to high complexity within a drug development program for Data Science (DS). You will perform external clinical data processing and reconciliation activities and may oversee CRO personnel performing the external clinical data processing and reconciliation activities as necessary. 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 foster inquisitive and collaborative ways of working. We are looking for individuals who have experience in processing or managing external data. You will support global studies and work as part of a team with members in the US and Japan.

Key activities are noted below:

• Creating and maintaining study level data transfer specifications (i.e., external data specifications).
• Processing test transfers and works with the external data provider 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, reviews the discrepancy output of reconciliation checks and exception listings and works with Data Management, Study Management, Bioanalysis and/or Stats/Stats Programming and/or the external data providers to resolve data discrepancies.
• Overseeing or acting as intermediate between Data Management, Statistical Programming and external data provider 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's standard data models. Making significant contributions, or may lead, the development and maintenance of external data standards and the processes needed to support their use and evolution.
• Assisting and providing study level support to study teams and other team members.
• Assessing complex data or procedural issues, chooses among alternatives, and facilitates resolution.

Essential Knowledge & Experience:

• Educated to degree level or equivalent in a biological science, health-related or computer science field.
• Demonstrated experience in managing external data processes for data management. This includes creation of external data transfer specifications; leading study level UAT and QC of external data transfers; performing reconciliation data checks on external data.
• In-depth knowledge of drug development strategy, clinical trial, and data management processes.
• Previous experience in a related clinical data management role.
• Excellent oral and written communication skills.
• Experience with eClinical Solutions elluminate is a plus.
• Strong understanding of different types of data sources in a clinical trial setting and/or expertise with external data types.
• Proven ability to think critically to enable judgement-based decisions related to data management activities.
• Ability to influence study teams and drive decision making.
• Demonstrated learning agility, ability to adopt new technologies for Data Management.

Additional information:

• The 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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