Note: The job is a remote job and is open to candidates in USA. Redbock, an NES Fircroft company, provides staffing and consulting support for clinical research and pharmaceutical organizations. The Lead Clinical Data Manager will lead outsourced clinical data management strategy and activities, oversee vendors and study setup, and ensure high-quality data review, cleaning, compliance, and database lock execution across complex clinical trials.
Responsibilities
- Review protocols from a CDM perspective and provide functional-expert feedback
- Review and approve key clinical data management deliverables generated by a DM vendor, including Case Report Form (CRF) design, CRF completion guidelines, database design specifications, data entry guidelines, data management plans, edit check specifications, serious adverse event reconciliation plans, medical coding, data listing specifications, and electronic data transfer agreements
- Manage / oversee study setup, testing and system validation for new studies in partnership with the DM vendor
- Oversee data cleaning activities executed by the DM vendor and ensures protocol-specified guidelines are applied to the review and cleaning of clinical data
- Collaborate with internal Data Science (statistical programming), internal Biostatistics, and internal Medical Monitor on identifying critical variables in the clinical dataset, for protocol-specified endpoints. Coordinate implementing these variables into DM vendor activities
- Develop and manage timelines for key clinical data management deliverables in coordination with the clinical data management vendor and project team
- Monitor vendor performance to ensure timelines and data quality standards are met
- Ensure compliance of clinical data management processes with applicable regulations and guidelines
Skills
- Must accommodate Pacific core hours specifically from 9am-3pm PT, if not on West Coast
- Bachelor's degree in a life sciences, health sciences, or related discipline
- Minimum of 12 years of clinical data management experience, with the ability to independently lead complex studies from initiation through database lock
- Minimum of 8 years of lead experience
- Demonstrated experience serving as Lead Clinical Data Manager for late-phase clinical trials and regulatory submissions
- Strong experience managing external data integrations, particularly specialty laboratory and other non-EDC data sources
- Proven expertise in CRO oversight, including vendor management, timeline management, and performance accountability
- Recent experience within a small biotechnology or pharmaceutical sponsor environment
- Strong in-house data management experience with a hands-on approach to study execution
- Extensive experience conducting and leading clinical data review activities
- Demonstrated success leading database lock activities and ensuring timely study completion
- Excellent project management, communication, and stakeholder management skills
- Self-starter with a proactive, growth-oriented mindset and strong problem-solving capabilities
- Experience providing clinical data management oversight at the program level across multiple studies
- Knowledge of authoring or reviewing edit check specifications and data listings specifications
- Experience supporting regulatory inspections and audits related to clinical trial submissions
- Prior experience in rare disease clinical trials
Benefits
- 12+ months renewable (3 year contract)
- US, Remote
- Must accommodate Pacific core hours specifically from 9am-3pm PT, if not on West Coast
Company Overview
Company H1B Sponsorship