CDM Manager

Clinical Data Management (CDM) supports drug discovery, development and marketed products by ensuring accurate and timely acquisition, analysis and reporting of clinical data through CRF/eCRF design, editing specifications, and query resolution. CDM also manages data transfers from vendors (e.g., central labs).

Responsibilities:
- Act as CDM lead; oversee CDM execution at the project level (products or complex studies).
- Lead CRF/eCRF design; review study protocols and plan/implement CDM portions of clinical studies.
- Oversee vendors for data review, transfers and reporting; use routine/non-routine reports to track progress and meet timelines/quality.
- Guide/training for CROs, vendors, investigators and study coordinators on CDM requirements.
- Support regulatory submissions; assist with CDM questions for audits/inspections; lead special projects as needed.
- Oversee CDM process design/implementation with vendors (entry, QC, transfer, reporting, backup/recovery).
- Ensure data completeness/accuracy/consistency and adherence to CDM system processes for regulatory compliance.

Requirements (Minimum Education & Experience):
- PhD in life sciences/related; or MA/MS with 4+ years; BA/BS with 6+ years in relevant CDM or data analytics/data management. Prefer PhD + 2+ years CDM/data management.
- Experience leading small projects/teams.

Knowledge & Other Requirements:
- Demonstrated leadership of CDM deliverables; knowledge of FDA/EMA regulations and NDA; strong project/risk management and communication.
- Ability to mentor, delegate, and adapt; travel when needed.

People Leader Accountabilities:
- Create Inclusion; Develop Talent; Empower Teams.

Benefits (if eligible): company-sponsored medical, dental, vision, life insurance; may include bonus/stock-based long-term incentives and paid time off.

Application instruction:
- For current employees/contractors: apply via the Internal Career Opportunities portal in Workday.