Director, Clinical Data Management

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About the role

Director, Clinical Data Management - growing biotech seeking a Data Management leader to support as the clinical pipeline moves to late stage!



Scroll down the page to see all associated job requirements, and any responsibilities successful candidates can expect.

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, Clinical 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.

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. xwzovoh


Contact

If you are interested, please apply to this job post. To contact Amit directly, you can email him at

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