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 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.
Digital Health Solutions Lead (UK)
The Opportunity
This is a technical leadership position, accountable for the definition, oversight, and operational execution of Data Management (DM) deliverables for the Quantitative Sciences and Evidence Generation (QSEG) eCOA/eSource Team. This may include clinical study and program level deliverables for eCOA, and for eSource capabilities, such as wearables, Electronic Health Records (EHRs), applications (apps), eConsent, etc.
In this role, you will be responsible to provide operational leadership for eCOA and eSource deliverables, and to lead process oversight for clinical study and program level implementation. This includes responsibility for project management and technical leadership for the end‑to‑end study phases of setup, conduct, and closeout. This role drives operational excellence, global regulatory compliance, training and technology vendor process oversight for all DHT study level solutions and activities.
Hybrid Working
At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
Key Activities For This Role
- Execution of eCOA and eSource process capabilities at a study, program, and enterprise level. This may include oversight and process ownership for the following: vendor deliverables and timelines, defining data collection, reporting and mapping requirements, establishing study level dataflow, technology/app and device deployment, testing, dataflow and data change oversight and archival activities.
- Establish process for cross‑functional coordination for eCOA/eSource implementation in collaboration with study teams, eCOA/eSource service provider(s), translations providers, and COA Specialist.
- Organize eCOA/eSource related meetings with vendors and study teams in accordance with Astellas processes.
- Oversight of risk assessments and mitigation strategies to ensure on‑time delivery of eCOA and eSource capabilities.
- Provide operational process oversight for eCOA/eSource vendors (Has a broad understanding of how source data come together, and/or how system vendors and solutions function to support the execution of the study).
- Have a comprehensive understanding and application of eSource principles and regulations and represents data standards, quality, and inspection readiness interests with key stakeholders and study teams.
- Ensure adherence with best practices, operational playbooks, guidance documents, SOPs, work practice documents, tools, databases, and standard templates for eCOA and eSource.
- Responsible for ensuring that all supporting operational documentation for studies/systems is maintained in accordance with processes to ensure quality, traceability, and regulatory compliance.
- Lead process improvement activities that support operational efficiencies.
- Provides feedback and recommendations for operational governance discussions with key eCOA and eSource technology vendors.
- Maintain a strong network of contacts both within and outside of Astellas to further develop breadth and depth of knowledge. Stays abreast of industry developments. Plays a leadership role in industry or professional organizations. Develops and maintains relationships with peers in the industry.
Essential Knowledge & Experience
- Demonstrated previous 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.)
- Demonstrated knowledge of the Clinical Development Process
- Clinical Trial Process - understanding of the clinical trial study process (e.g., data standards, regulations, guidelines, delivery of data to audiences, drug development/RBQM components, etc.)
- Vendor Landscape - working knowledge of pharmaceutical vendors/CROs and how they are used to execute on Data Science activities
- Analytical systems - understanding of and experience with central monitoring systems, Elluminate, reporting and visualization tools, etc.
- Data management - deep understanding of the data management process, lifecycle and key activities (e.g., ETL, data quality, knowledge of database systems, etc.).
- Data types - understanding of and experience with different data types (e.g., audit trail review, eCOA, EDC, External, Labs, etc.)
- Project Management - identifies and communicates project goals, timelines, and milestones; identifies project interdependencies and potential constraints; assigns roles and holds stakeholders accountable to meet project outcomes on time and within budget
- Stakeholder/Team Management & Alignment - understands and clearly communicates the goals of internal teams and external stakeholders (i.e., vendors), and their expected impact to the project/study; ensures they meet their goals and expectations; ensures cross-functional and cross-divisional collaboration; shows ability to deliver through others.
- Demonstrated active contribution to inspections and major (vendor) audits.
- Expert knowledge of local and international regulations for clinical trials (e.g., GCP).
- Expert level understanding of data integrity principles and other associated industry and regulatory level best practices and requirements.
- Excellent verbal and written communication skills.
- Demonstrated learning agility, ability to rapidly adopt new technologies for Data Management.
- Proven ability to work with and influence individuals across multiple disciplines and organizational levels in international environment.
Preferred Experience
- Professional certification in a Clinical Development discipline
- Demonstrated 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.
Education
- BS in Computer Science, Informatics, or life science discipline
Additional Information
- This is a permanent, full‑time position, based in the United Kingdom.
- This position follows our hybrid working model. Role requires a blend of home and minimum once a quarter in office. Flexibility may be required in line with business need.
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.
Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help.
