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Precision for Medicine seeks a Senior Clinical Data Manager to lead clinical trial data management operations from study initiation through database lock. This role serves as the primary data management contact for assigned clinical projects, overseeing all aspects of the data lifecycle including database development, testing, and quality assurance.
Key responsibilities include: managing the clinical data entry process with oversight of guidelines, training, and quality control; developing CRF specifications from study protocols and coordinating stakeholder feedback; conducting database build UAT and maintaining quality-controlled documentation; specifying and overseeing edit check development; training clinical research personnel on study-specific systems; reviewing and querying clinical trial data per the Data Management Plan; performing medical coding and SAE/AE reconciliation; liaising with third-party vendors including EDC providers; assisting with SAS programming and QC; identifying and troubleshooting operational issues; and participating in SOP development.
The role also includes cross-functional leadership, strategy meeting participation, RFP review, proposal development, and occasional travel. The candidate will train and mentor data management team members and communicate regularly with study sponsors, vendors, and project teams on data and database issues.
Required qualifications: Bachelor's degree and 10+ years of clinical data management experience; proficiency in Microsoft Office; strong organizational and communication skills; experience with various clinical database management systems; broad knowledge of drug, device, and biologic development; and strong leadership and interpersonal skills. Preferred: clinical or healthcare background; medical coding experience (MedDRA, WHODrug); CDISC standards knowledge (CDASH, SDTM, ADaM); oncology or orphan drug experience.
