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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 the Lead Data Manager as a backup and team member, ensuring continuity and timely task completion across assigned projects.
Key responsibilities include: supporting clinical data management processes and database development; performing data entry and quality control for paper-based CRF studies; assisting in CRF specification development from study protocols and coordinating stakeholder feedback; building and conducting UAT for clinical databases while maintaining quality documentation; 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 tools; reviewing and querying clinical trial data per Data Management Plans; performing line listing data reviews; running patient and study-level status reporting; performing medical coding to ensure consistency; assisting with SAE/AE reconciliation; liaising with third-party vendors (EDC, data vendors) in a project management capacity; potentially assisting with SAS programming and QC; identifying and troubleshooting operational issues using metrics and audit data; assisting with protocol, SAP, and CSR reviews as needed; participating in SOP development and maintenance; training data management team members; communicating with sponsors, vendors, and project teams; presenting software demonstrations and trainings; and performing other assigned duties.
Required qualifications: 5+ years of experience; Bachelor's degree and/or equivalent related experience; proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook); ability to handle diverse clinical research tasks; excellent organizational and communication skills; professional English proficiency (written and oral); basic knowledge of drug, device, and/or biologic development and effective data management practices.
Preferred qualifications: experience in clinical, scientific, or healthcare disciplines; dictionary medical coding (MedDRA, WHODrug); understanding of CDISC standards (CDASH, SDTM, ADaM); oncology and/or orphan drug therapeutic experience. Strong knowledge of ICH-GCP, relevant SOPs, and regulatory guidance required.
