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 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:
You will act as a data management lead and represent Quantitative Sciences and Evidence Generation (QSEG) as the key data management (DM) contact in clinical study team meetings and some extended team discussions. You will be responsible for study-level data management activities within a drug development program. This includes all aspects of study-level DM deliverables—such as data standards, eSource, Medical Coding, database build, external data, and central monitoring—as well as the overall management and oversight of all data management activities for your assigned projects. You will ensure that studies within the program are executed within agreed timelines and in accordance with global standards and processes. You will hold full accountability for DM deliverables across multiple studies and be responsible for all vendor oversight related to any outsourced DM activities.
Hybrid Working:
At Astellas we recognise that our employees enjoy having balance between their professional and home lives. We are proud of our hybrid approach which empowers you to have flexibility on whether to work from home or in the office.
Key Responsibilities:
- Oversees the collection of all clinical trial data from multiple sources.
- Very strong subject matter expertise in the Data Management (DM) discipline. Can support multiple studies concurrently with little to no oversight by functional manager.
- Performs DM vendor oversight activities across multiple studies. Reviews and gives input in vendor oversight processes.
- 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.
- Provides training and subject matter expertise to lower-level DM peers.
- Collaborate with clinical operations, investigators, and other stakeholders to ensure smooth data flow throughout the trial.
Essential Knowledge & Experience:
- Strong computer skills, including database management software, reporting tools, medical coding tools, and solid understanding of Central Monitoring tools etc.
- Strong understanding of different types of data sources in a clinical trial setting and/or expertise with external data types.
- Pharmaceutical, clinical research or health services industry related experience with experience as Data Manager with progressive levels of responsibility.
Preferred Experience:
- Professional Certification in a clinical development discipline.
Education/Qualifications:
- BS/BA degree in a biological science, statistics, health-related or computer science field. Advanced degree preferred or equivalent.
Additional Information:
- This is a permanent, full-time position.
- This position is based in the United Kingdom or Poland.
- This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per quarter in our Addlestone/Warsaw office. Flexibility may be required in line with business needs.
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.
#LI-Addlestone
#LI-Hybrid