Clinical Data Manager Lead

1 month ago

London, Greater London, United Kingdom Indivior Full time
Job Title: Lead (Clinical) Data Manager

Job Summary:

The Lead (Clinical) Data Manager is responsible for ensuring the accuracy, reliability, and completeness of Phase I-IV clinical databases. This role leads the end-to-end data management activities for assigned trials, ensuring timely and quality delivery of clinical trials data.

Key Responsibilities:
  • Oversee the 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, developing and tracking vendor performance metrics.
  • Provide oversight of designated activities outsourced to CROs, external consultants, central and specialist labs, and other data vendors, utilizing key performance indicators and metrics to assess vendor quality and performance.
  • Participate in protocol design and review, providing input related to the operationalization of the design and data collection, ensuring consistency and adherence to data standards.
  • Lead or assist with development of trial-specific Data Management documents, including Data Management Plans, eCRF Completion Guidelines, database specifications, data validation/data quality plans, external data transfer specifications, and SDTM mapping specifications.
  • Lead or assist with review of trial-specific eCRF and SDTM deliverables to ensure compliance with CDISC and applicable company data standards.
  • Lead or assist with development of User Acceptance Testing (UAT) plans, coordinating and/or participating in UAT execution.
  • Oversee reconciliation of external data sources, partnering with Pharmacovigilance colleagues to perform reconciliation of serious adverse events and other trial-specific events, as required.
  • Proactively organize and facilitate holistic data review by the Indivior team throughout the conduct of trials to ensure timely and appropriate identification of trends, anomalies, and quality issues.
  • Ensure proper closeout and archival of Data Management trial documentation, as required by the trial-specific Trial Master File Oversight Plan.
  • 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/Clinical Data Management Systems (Medidata Rave preferred) and Centralized/Risk-Based Monitoring.
  • 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/Conduct:
  • Excellent project management and organizational skills with great attention to detail and the demonstrated ability to successfully manage multiple trials concurrently.
  • Excellent verbal and written communication skills, including proven abilities in cross-functional collaboration, cooperation, and building relationships.
  • 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; experience with developing and implementing operational processes and systems.
  • Excellent problem-solving, organizational, and negotiating skills.
  • Ability to interact effectively across boundaries with other functions and disciplines using influencing, communication, and relationship-building skills.
Benefits:
  • 25 days holiday plus public holidays.
  • Flexible working; core hours are 10am-3pm, and we offer up to 2 days working from home/week for office-based roles, as well as a flexible Friday program, subject to completion of contractual hours.
  • 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 such as gym membership, shopping, holidays.

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