Key Duties & Responsibilities
- End-to-end external data delivery, R&D across clinical trials, companion diagnostics, clinical development, and regulatory submissions.
- Collaborate with Clinical, Medical, QCP, Clinical Biomarkers, Clinical Safety, CROs, and external vendors (Central Labs, Specialty Labs, Biomarker Vendors, CDx).
- Optimize data collection services to ensure high-quality, timely, and compliant delivery of all third-party data.
- Validate electronically transmitted external data to meet quality requirements and protocol-defined endpoints (primary, secondary, exploratory).
- Work with both EDC & Non-EDC data; ensure integration and import from CROs, vendors, and partners.
- Provide oversight and execution of Companion Diagnostics (CDx) development to support science-based decision-making.
- Lead program / therapeutic-level data collection processes and maintain consistency in acquisition, processing, and reporting.
- Participate in Contract / SOW and MSA reviews with external vendors to establish data standards and cleaning needs.
- Serve as Subject Matter Expert for study data managers during all study phases (startup, conduct, close-out).
- Maintain and review SOPs, SOIs, EFTs, eDTS for standardization across programs.
- Act as primary contact for data quality issue escalations.
- Promote cross-functional collaboration and positive stakeholder relationships.
Required Skills & Experience
4 years in external data management with strong 3rd party vendor oversight experience.4 years clinical data management in pharma, medical device, or CRO setting.Must have oncology, immunology, or complex disease therapeutic experience.Knowledge of CDISC, SDTM, industry data collection practices.Familiarity with clinical trial data systems / EDC (Medidata Rave, Oracle InForm, etc.).Excellent communication, organizational, analytical, and interpersonal skills.Proven ability to work in fast-paced, cross-functional, multicultural environments.Education
Master's Degree in life sciences or related field (or equivalent experience) preferredBachelor's Degree in life sciences or related field (or equivalent experience) requiredRN in life sciences or related field (or equivalent experience) preferredJ-18808-Ljbffr