Note: The job is a remote job and is open to candidates in USA. Redbock, an NES Fircroft company, provides staffing and professional services support for specialized industries. The Senior Clinical Data Manager serves as a data management expert or CDM Lead for clinical studies, overseeing data management deliverables, vendor performance, data quality, timelines, and regulatory compliance across multidisciplinary teams.
Responsibilities
- Serve as a data management expert and, if assigned, be the CDM Lead for assigned clinical studies on multidisciplinary project teams
- Deliver high quality data for analysis and study milestones
- 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
- Typically requires a Bachelor's degree in mathematics, science, or a health-related field and a minimum of 10 years of clinical data management experience in biotech, pharmaceutical, or health-related industries
- Demonstrated proficiency leading CDM deliverables across Phase 1–3 clinical trials, including early-phase and dose-escalation studies
- Solid understanding of the clinical drug development process and regulatory/data standards (ICH/FDA, CDISC - CDASH, SDTM, ADaM - GCDMP, 21 CFR Part 11, MedDRA, WHO Drug Dictionaries, GDPR)
- Demonstrated understanding of the clinical trial database life cycle, including CRF design, development/testing, discrepancy management, data quality review, and database lock
- Capable of proactively identifying project risks and proposing strategic solutions; excellent multi-disciplinary interpersonal and communication skills
- Strong analytical and problem-solving skills; able to work independently and within cross-functional project teams
Company Overview
Company H1B Sponsorship