Clinical Data Manager Lead

2 weeks ago

London, Greater London, United Kingdom Indivior Full time

Job Summary:

The Lead Clinical Data Manager will be responsible for the accuracy, reliability, and completeness of Phase I-IV clinical databases and will lead the end-to-end data management activities for assigned trials.

Key Responsibilities:

  • Ensure quality and timely delivery of clinical trials data.
  • Participate in vendor evaluation, qualification, and selection activities, including review and assessment of SOPs, contracts, and budgets.
  • Represent Data Management at trial-specific meetings and serve as primary contact for external vendors.
  • Provide oversight of designated activities outsourced to CROs, external consultants, central and specialist labs, and other data vendors.
  • Participate in protocol design and review, providing key input related to the operationalization of the design and data collection.
  • Lead or assist with development of trial-specific Data Management documents, including Data Management Plan, eCRF Completion Guidelines, and database specifications.
  • Lead or assist with review of trial-specific eCRF and SDTM deliverables to ensure compliance with CDISC and applicable company data standards.
  • Oversee reconciliation of external data sources and partner with Pharmacovigilance colleagues to perform reconciliation of serious adverse events and other trial-specific events.
  • Ensure proper closeout and archival of Data Management trial documentation.
  • Ensure compliance with all applicable laws, regulations, and regulatory guidelines.

Requirements:

  • Minimum of Bachelor's degree with 7 years of experience or Master's degree with 5 years of experience as a Clinical Data Manager in the pharmaceutical or biotech industries.
  • Strong knowledge in all aspects of Clinical Data Management.
  • Advanced knowledge of and experience using EDC platforms and Clinical Data Management Systems.
  • Knowledge of medical terminology, MedDRA and WHODrug dictionaries, and database design concepts.
  • Working knowledge of ICH, FDA, CFR, GCP, HIPAA, GCDMP regulations and guidelines.
  • Working knowledge of and experience implementing CDISC CDASH / SDTM / ADaM standards.

Competencies:

  • Excellent project management and organizational skills.
  • Excellent verbal and written communication skills.
  • Demonstrated vendor management skills.
  • Proven ability to work proactively, efficiently, and effectively in a fast-paced environment.
  • Flexible, well-organized, and works well under pressure and amid changing priorities.
  • Proven excellence in operational strategy.
  • Excellent problem-solving, organizational and negotiating skills.

Benefits:

  • 25 days holiday plus public holidays.
  • Flexible working with core hours and optional remote work.
  • Paid Volunteer Time Off.
  • 10% company pension.
  • EAP service including Legal, Health and Wellbeing support.
  • Optional Health Insurance with BUPA.
  • Company Death in Service and Payment Protection Insurance.
  • Access to platform for discounts on gym membership, shopping, and holidays.

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