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.
The Opportunity:
As a Data Management Lead, you will be responsible for study level data management activities of moderate to high complexity within a drug development program for Data Science (DS). This includes all aspects of DM deliverables (data standards, eSource, Medical Coding, database build, external data, central monitoring, etc.), and overall management/oversight of all data management.
You will be also responsible for applying your external data expertise to standardize and streamline review and cleaning of data received through routes other than the EDC system. Your role also works with external providers and other stakeholders to resolve data discrepancies throughout the course of clinical study conduct.
Hybrid Working:
At Astellas we recognise the importance of balancing your work and home life, so we offer a hybrid working solution allowing time to connect with colleagues in person at the office alongside the flexibility to work from home; optimising the most productive work environment for you to succeed and deliver.
Key Activities for this role:
- Lead the data review meetings with Medical, Clinical Operations, Statistics, and Stats Programming in support of key reporting events or database lock plans.
- Create and maintains study level data transfer specifications (i.e., external data specifications).
- Process test transfers and liaises with the external data provider to verify the data structure and format.
- Define the study level specifications for reconciliation checks and exception listings to perform the reconciliation between EDC data and external data.
- Manage external 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 discrepancies.
Essential Knowledge & Experience:
- Experience in pharmaceutical, clinical research or health services industry as Data Manager, with progressive levels of experience with varying study types and phases.
- 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.
- Experience with eSource systems/devices. And strong knowledge of the different data sources in a clinical trial setting.
- Solid understanding of international regulations for clinical trials (e.g. GCP) and familiar with CDASH/CDISC standards.
- Ability to communicate effectively and maintain effective relationships.
- Demonstrated learning agility, ability to adopt new data management technologies and capabilities.
Education:
- BS/BA degree in a biological science, health-related or computer science field or equivalent.
Additional Information:
- The is a permanent, full-time position based in the UK.
- This position follows our hybrid working model. Role requires a blend of home and once per quarter in our Addlestone office. Flexibility may be required in line with business need. Candidates must be located within a commutable distance of the office.
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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