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Precision for Medicine seeks a Senior Clinical Data Associate to provide comprehensive data management support throughout the clinical trial lifecycle, from study initiation through post-database lock. This role supports Lead Data Managers as a backup team member, ensuring continuity and timely task completion across assigned projects.
Key responsibilities include: performing data entry and quality control for paper-based CRF studies; developing CRF specifications from clinical protocols and coordinating stakeholder feedback; assisting in clinical database building and conducting database build UAT; specifying requirements for edit checks (electronic and manual); creating and maintaining data management documentation with appropriate versioning; training clinical research personnel on study-specific CRF, EDC, and project deliverables; reviewing and querying clinical trial data per the Data Management Plan; performing line listing data review; running patient and study-level status reporting; performing medical coding to ensure medical logic and consistency; assisting with SAE/AE reconciliation; liaising with third-party vendors (EDC, data vendors) in a project management capacity; assisting with SAS programming and QC; identifying and troubleshooting operational issues based on metrics and audit reports; reviewing protocols, SAPs, and CSRs as needed; participating in SOP development; training data management team members; and communicating with sponsors, vendors, and project teams on data and database issues.
The role requires 5+ years of clinical data management experience and a Bachelor's degree (or equivalent combination of related experience). Essential skills include proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook), strong organizational and communication abilities, professional English (written and oral), and basic knowledge of drug/device/biologic development and data management practices. Preferred qualifications include clinical, scientific, or healthcare background; medical coding expertise (MedDRA, WHODrug); understanding of CDISC standards (CDASH, SDTM, ADaM); and oncology or orphan drug therapeutic experience. The role requires strong knowledge of ICH-GCP, relevant SOPs, and regulatory guidance, with demonstrated ability to motivate team members, drive continuous improvement, and resolve complex data issues.
