Title: Lead CDM
Type: 6-month W2 Contract
Location: Remote, PST Hours
A midsized pharma is seeking an experienced lead CDM:
- 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.
- Reviews 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 protocolspecified 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 guideline
- BA/BS or higher preferably in math, science or health-related field with a minimum of
- 9+ years of experience as a clinical data management across phase 1- 3 clinical trials
- At least 5 years of the overall experience acting as a study lead data manager. Experience on all study phases including early phase, dose escalation studies is greatly preferred
- CNS/Neurodegenerative trial experience is greatly preferred
- Comprehensive experience working with clinical database systems
- Working knowledge of CDISC including CDASH, TAUG and SDTM as well as data privacy regulations e.g. GDPR
Please note that this role is only offered on W2. If you are interested, please do not hesitate to apply!