Data Management Lead
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 caregivers, 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 within a drug development program. This includes all aspects of study level DM deliverables (data standards, eSource, Medical Coding, database build, external data, central monitoring, etc.), and overall management/oversight of all data management activities for assigned projects. The individual ensures that studies within the program are executed within the agreed timelines and according to the agreed global standards and processes. You will have to take full accountability for the DM deliverables across multiple studies and is responsible for all vendor oversight for any outsourced DM activities.
The position contributes expert level Data Management knowledge and consultation to the clinical program team, as well as to other stakeholders within Development. This role may act as a key contact and lead of DM process and technical/systems improvement initiatives.
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:
- Very strong subject matter expertise in the Data Management (DM) discipline. Can support multiple studies concurrently with little to no oversight by functional manager.
- May act as a functional DM expert for a specific DM specialty area, such as data standards, Medical Coding, eSource, external data, data visualization and analytics, etc.
- Review Key Risk Indicators (KRIs) outputs in aggregate across sites, regions and countries. As needed, review study level operational and patient data to support the investigation and root cause analysis of observations.
- Performs vendor oversight activities across multiple studies. Reviews and gives input in vendor oversight processes. Proactively shares and provides suggestions on how to improve vendor oversight. Uses metrics and key performance indicators (KPIs) to monitor vendor performance.
- Documents any process related deviations and communicates to functional manager. Triggers discussion or takes immediate action if there are concerns with respect to quality of DM deliverables.
- Leads the data review meetings for all data sources with Medical, Clinical Operations, Biostatistics, and Programming to highlight and discuss deviations to the protocol and specific data values relevant for the analysis/determining subject populations.
- Strong understanding of regulatory requirements, such as GCP, and how they impact Data Management activities and outputs.
Essential Knowledge & Experience:
- Substantial years of relevant experience in pharmaceutical, clinical research, or health services industry, including strong experience as a Data Manager with progressive leadership responsibility.
- Demonstrated expertise in Data Management from program inception through regulatory submission (regulatory submissions experience preferred).
- Recognized leadership and subject matter expertise in Data Management related global process improvement initiatives.
- Extensive experience with external data management and digital health solutions (e.g., eSource, eCOA, eConsent), including edata processes, central monitoring tools, and risk-based quality management (RBQM) principles.
- Advanced understanding of clinical data standards (e.g., CDISC) and ability to apply standards across studies and programs.
- Prior inspection and audit experience.
Preferred Qualification:
- SCDM Certified Clinical Data Manager (CCDM) preferred.
- Experience with RAVE, eClinical Solutions elluminate and CluePoints is a plus.
Educations/Qualifications:
- Bachelor’s degree in biological science, health-related or computer science field or equivalent experience.
Additional information:
- The is a permanent full-time position.
- This position is based in the UK.
- This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per quarter in our local office. Flexibility may be required in line with business needs. 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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