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Director, Data Management
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Director, Data Management for growing
Employment Type: Full-time, permanent
Work setup: Remote across the UK
We're partnered with an innovative, growing biopharmaceutical company focused on advancing clinical-stage therapies in the anti-infective and antibiotic space. As the Director, Data Management, you will serve as the company Data Management leader, providing both strategic ownership of the function and hands-on oversight of clinical data management activities across the portfolio. Reporting to the VP, Clinical Operations, you will be responsible for ensuring data integrity, regulatory compliance, inspection readiness, and high-quality delivery across outsourced clinical programs.
This is a highly visible, hands-on opportunity for an experienced Data Management professional who can effectively manage CRO and vendor relationships while also owning day-to-day execution. The role is ideally UK-based, with strong European candidates also considered, and will work across multiple international time zones.
Job Duties
- Serve as the primary Data Management subject matter expert and accountable leader across all clinical studies, establishing sponsor-level standards, governance processes, SOPs, and quality frameworks.
- Lead the selection, oversight, and performance management of CROs and data vendors, serving as the primary Data Management contact and driving governance meetings, issue resolution, and delivery against expectations.
- Oversee clinical data systems and end-to-end data management activities, including EDC and RTSM/IRT selection and validation, database development, edit checks, medical coding, query management, external data reconciliation, and database lock.
- Ensure data integrity, quality, and inspection readiness across clinical programs, including TMF completeness, audit trails, data lineage, and preparation for audits and regulatory inspections.
- Partner closely with Clinical Operations, Biostatistics, and Statistical Programming teams to ensure Data Management deliverables align with interim analyses, DSMB reviews, SDTM/ADaM programming, and final database lock timelines.
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Job Requirements
- Bachelor's degree or equivalent in Life Sciences, Health Sciences, or a related discipline, with 10+ years of Data Management experience within a pharmaceutical or biotech environment.
- Proven experience leading Data Management activities for Phase 2/3 clinical trials, ideally within the anti-infective or antibiotic therapeutic area.
- Demonstrated hands-on experience selecting and managing CROs and data vendors, overseeing outsourced Data Management deliverables, and holding external partners accountable for quality and timelines.
- Recent experience in inspection readiness is highly desired!
- Strong knowledge of ICH-GCP, 21 CFR Part 11, global regulatory requirements, CDISC standards including CDASH and SDTM, and medical coding dictionaries such as MedDRA and WHO-DD; experience with major EDC platforms such as Medidata Rave or Veeva Vault EDC and RTSM/IRT systems.
- Strong communication, data analysis, and stakeholder management skills, with the ability to operate as an individual contributor in a small-company environment and translate complex data findings into clear, actionable insights for wider audiences.
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Contact
If you are interested, please apply to this job post. To contact Amit directly, you can email him at amit.uma@meetlifesciences.com.
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