Manager Data Management

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) preferred

• Bachelor’s Degree in life sciences or related field (or equivalent experience) required

• RN in life sciences or related field (or equivalent experience) preferred Skills and Experience: