Data Management Lead - UK
About Astellas
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need.
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Are you driven to make a real difference in the lives of patients?
We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.
Location and Working Environment
This is a permanent role based in Addlestone, UK and hybrid working with the expectation to be onsite once per quarter.
Astellas' Responsible Flexibility Guidelines Statement- 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.
Purpose & Scope
This position acts as a data management lead and represents Quantitative Sciences and Evidence Generation (QSEG) as the data management (DM) key contact in clinical study team meetings and some extended team discussions.
The role is 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. The individual has 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.
Role And Responsibilities
Very strong subject matter expertise in the Data Management (DM) discipline. Can support multiple studies concurrently with little to no oversight by functional manager.
Advocate the DM position on technical processes within study team meetings. Share DM process knowledge with study team colleagues and cross functional peers.
Oversee multiple DM vendors and provide training and subject matter expertise to lower-level DM peers.
Lead by example by providing data management expertise and input into drug development programs.
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.
Support the team in assessment of centralized monitoring observations to identify potential issues and risks occurring during study conduct.
Perform vendor oversight activities across multiple studies. Review and give input in vendor oversight processes. Proactively share and provide suggestions on how to improve vendor oversight. Uses metrics and key performance indicators (KPIs) to monitor vendor performance.
Document any process related deviations and communicates to functional manager. Trigger discussion or take immediate action if there are concerns with respect to quality of DM deliverables.
Expert cross-functional understanding on the impact of data management processes to other stakeholders.
Lead 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.
Required Qualifications
Bachelor's degree in Biological Science, health-related or Computer Science field (or equivalent experience).
Seasoned relevant experience in pharmaceutical, clinical research, or health services industry, including 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.
Strong computer skills including database management software, reporting tools, and medical coding systems.
In-depth knowledge of different data sources in clinical trial settings and associated data quality considerations.
Prior inspection and audit experience.
Proven project management and organizational skills to prioritize and direct work for self and others to meet timelines.
Ability to influence and guide study teams, driving decision making and issue resolution across
functions and vendors.
Demonstrated critical thinking and sound judgement in complex or ambiguous data management scenarios.
Demonstrated learning agility and ability to drive adoption of new technologies and capabilities for Data Management.
Preferred Qualifications
SCDM Certified Clinical Data Manager (CCDM) preferred.
Experience with RAVE, eClinical Solutions elluminate and CluePoints is a plus.
Understanding of the clinical trial study process.
Working knowledge of pharmaceutical vendors/CROs and how they are used to execute on Data Science activities.
Understanding of and experience with central monitoring systems, Elluminate, reporting and visualization tools, etc.
Deep understanding of the data management process, lifecycle and key activities (e.g., ETL, data quality, knowledge of database systems etc.)
Understanding of and experience with different data types (e.g., audit trail review, eCOA, EDC, External, Labs, etc.).
What awaits you at Astellas?
Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.
Our Organizational Values and Behaviors
Impact
Innovation
Integrity
One Astellas
Accountability
Courage
Sense of Urgency
Outcome Focus
Benefits
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We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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Addlestone