Associate Director Clinical Data Manager (all genders)
The businesses of Merck KGaA, Darmstadt, Germany · GB
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About the Role
Lead end-to-end data management delivery for assigned global clinical trials, focusing on complex oncology, neurology, or immunology development. Set strategic direction for data collection, cleaning, review, reconciliation, and quality activities to ensure data accuracy, integrity, and submission-readiness. Serve as the primary Clinical Data Management representative, providing operational expertise and aligning cross-functional and global teams. Implement risk-based data management strategies, identify automation opportunities, oversee vendor delivery, and support Health Authority submissions. Contribute to process improvement, SOP development, and colleague mentoring.
Responsibilities
- Lead end-to-end data management delivery for assigned global Phase I–IV clinical trials or a defined study portfolio.
- Set the strategic direction for data collection, cleaning, review, reconciliation, and quality activities.
- Ensure the accuracy, integrity, completeness, and submission-readiness of clinical trial data.
- Serve as the primary Clinical Data Management representative at the study/program level.
- Provide operational expertise and align cross-functional and global teams in a matrix organization.
- Implement risk-based data management and data-flow strategies for in-house and outsourced studies.
- Identify opportunities to apply automation, advanced analytics, and AI-enabled solutions.
- Oversee CRO/vendor delivery.
- Support Health Authority submission activities by providing data management expertise and reviewing relevant materials.
- Actively shape the future of the function through process improvement initiatives.
- Contribute to SOPs and best-practice workstreams.
- Facilitate knowledge sharing and mentor colleagues.
Requirements
- Hold a Bachelor’s or Master’s degree in a scientific or technical discipline — life sciences, data management, or a related field.
- At least 10 years of experience in clinical data management within the pharmaceutical, biotechnology, or healthcare industry.
- Substantial leadership of complex oncology, neurology, or immunology trials at study and program level.
- Deep expertise in end-to-end data management, including risk-based data collection and cleaning strategies, eCRF design, external data management, and coding.
- Strong knowledge of CDISC, CDASH, and SDTM standards.
- Proven track record of managing CRO/vendor relationships, including operational performance oversight and budget monitoring.
- Experience in in-house sourcing models.
- Skilled at leading and coordinating global, cross-functional teams in a matrix environment.
- Confident providing updates on study progress, financials, forecasts, risks, issues, and timelines to senior stakeholders.
- Strong project management capabilities — planning study timelines and resources, identifying and mitigating risks, resolving issues, and managing multiple priorities simultaneously with a high degree of independence.
- Committed to continuous improvement and bringing external insights to contribute to innovation, process development, and the evolution of data management standards and SOPs.
- Experience with Risk Based Data Monitoring and Management is preferred.
- Experience evaluating or implementing automation and/or AI-enabled innovations in clinical data management, with an understanding of data quality, traceability, validation, human oversight, and compliance considerations, is an advantage.
Skills
- Clinical Data Management
- Oncology
- Neurology
- Immunology
- Data Collection
- Data Cleaning
- Data Review
- Data Reconciliation
- Data Quality
- Risk-Based Data Management
- eCRF Design
- External Data Management
- Coding
- CDISC
- CDASH
- SDTM Standards
- CRO/Vendor Management
- Project Management
- Process Improvement
- SOP Development
- Automation
- AI-enabled Solutions
Location
- Feltham
Work Type
- On-site (3 days per week)
- Hybrid
Experience Level
- Senior
- 10+ years
Education Level
- Bachelor's degree in a scientific or technical discipline
- Master's degree in a scientific or technical discipline