Digital Health Solutions Manager

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:

We have an exciting opportunity for Digital Health Solutions Manager (eCOA/eSource) to join our new hub Data Science team in the UK/Ireland to work within our established Data Science on a global scale alongside over 200 team members internationally.

This is an exciting time to join Astellas as we expand our global team. As an organisation that aims to stand on the forefront of healthcare change, we are looking for self-motivated individuals to join us, could this be you?

Hybrid Working:

At Astellas we recognize the importance of balancing your work and home life. This role offers a remote working solution so you can optimize the most productive work environment for you to succeed and deliver.

Key Activities for this role:

· The position is responsible for the end-to-end technical implementation and execution of eCOA/eSource capabilities in a study.

· This role with work with clinical study teams, eCOA/eSource service providers, and translations service providers to plan for on-time delivery of all study-related eCOA/eSource systems.

· This role encompasses assessing risks and determining mitigations; defining data collection, reporting, and mapping requirements; establishing study level dataflow, technology/app and device deployment; user acceptance testing; data reconciliation, data change oversight and archival activities.

· Demonstrated previous experience in pharma or CRO industry in either an eCOA or relevant Data Management role and solid knowledge of the Clinical Development Process.

· Previous experience with eCOA implementation and delivering eCOA/eSource process capabilities at the clinical study level.

· Established processes for cross-functional coordination for eCOA/eSource implementation in collaboration with Study Teams, eCOA/eSource service providers, and translations providers.

· Strong and demonstrated foundational DM skills (e.g., defining data collection requirements, applying data integrity principles, database design, dataflow etc.) in multiple drug development programs, inclusive of all activities through regulatory submission.

· Experience in ensuring that all supporting operational documentation for studies/systems is maintained in accordance with processes to ensure quality, traceability, and regulatory compliance.

Preferable Knowledge/Experience:

· Previous experience with eSource solutions implementation (wearables, eConsent, videography, EHR to EDC, etc.) is preferred.

Educations/Qualifications:

· BS in Computer Science, Informatics, or Life Science discipline.

· This is a permanent, full-time position based in the UK/Ireland.

· 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.

Job Types: Full-time, Permanent