Clinical Digital Technologies Lead, eCOA/eSource

About Astellas:

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

We pursue innovative science, focusing 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:

Would you like to join an organisation that aims to stand on the forefront of healthcare change, turning innovative science into VALUE for patients? We are currently recruiting for Clinical Digital Health Technologies Lead at various levels.

You will be responsible for end-to-end technical implementation and execution of eCOA/eSource capabilities in a study. You will work with the Astellas Lead Data Manager, clinical study teams, eCOA/eSource service providers, and translations service providers to plan for on-time delivery of all study related eCOA/eSource systems.

You will be facilitating updates to the eCOA/eSource system, assesses and addresses risks, develops testing plans, and participates in data reconciliation activities at the individual study level. You will provide subject matter expertise and support during inspection-related activities, working alongside the study team to complete decommissioning and archival of the data at study conclusion.

This is an excellent opportunity and be part of our global team with members in the US, UK, China, and Japan, that supports global studies. You could also partner cross-functionally within the organization to define workflows, assess gaps, define training needs, and provide guidance for inspections.

We are looking for individuals with excellent verbal and written communications skills, with the ability to work and influence individuals across multiple discipline in an international environment.

Key activities are noted below:

• Delivering eCOA and eSource process capabilities at the clinical study level. This includes oversight and process ownership for the following: eCOA vendor deliverables and timelines, defining data collection, reporting, and mapping requirements, establishing study level dataflow, technology/app and device deployment, testing, dataflow & data change oversight, and end-of-study archival activities.
• Establishing process for cross-functional coordination for eCOA/eSource implementation in collaboration with Study Teams, eCOA/eSource service providers, and translations providers.
• Leading eCOA/eSource related meetings with vendors and study teams in accordance with Astellas processes.
• Performing risk assessments and mitigation strategies to ensure on-time delivery of eCOA and eSource capabilities at the study level.
• Acting as the subject matter expert for eCOA activities and deliverables. Has a comprehensive understanding of eSource principles and regulations, and represents data standards, quality and inspection readiness interests with key stakeholders and study teams.
• Ensuring adherence with best practices, operational playbooks, guidance documents, SOPs, work practice documents, tools, databases, and standard templates for eCOA and eSource.
• Ensuring that all supporting operational documentation for studies/systems is maintained in accordance with processes to ensure quality, traceability, and regulatory compliance.
• Providing feedback and recommendations for operational governance discussions with key eCOA and eSource technology vendors. Uses KPIs and metrics to monitor eCOA vendor performance.

Essential Knowledge & Experience:

· Educated to degree level or equivalent Computer Science, Informatics, or life science discipline.

· Demonstrated experience in pharma or CRO industry in either an eCOA or relevant Data Management role.

· Seasoned expert with eCOA implementation and experience with eSource solutions implementation (wearables, eConsent, videography, EHR to EDC etc.).

· Strong project management skills and ability to anticipate and mitigate risk.

· Mastery of relevant 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 from program inception to regulatory submission.

· Demonstrated active contribution to inspections and major (vendor) audits.

· Solid cross-functional understanding of the processes of clinical development, with previous expertise expected in the DM discipline.

· Strong computer skills, including database software management, data reporting tools or similar programmes.

Additional information:

• The is a permanent full-time position based in the UK.
• This position is home / remote based.

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: Permanent, Full-time

Work Location: Remote