Manager, Clinical Data Management

Responsibilities:
- Lead/oversee outsourced and in-house clinical data management to support Phase 1–4 trials worldwide.
- Manage and monitor CRO/vendor data management progress; oversee CRO performance and provide updates to Head of Data Management.
- Lead EDC (data capture) systems testing, upgrades, migrations, report production, and query management per company standards.
- Review protocols and ensure appropriate data points are captured in eCRFs; develop and review DTA/DTS.
- Create and maintain study-specific data management documentation; manage study build process and data build specifications.
- Extract/analyze clinical data using visualization tools and SAS listings to identify trends/issues and communicate with CROs for regulatory-compliant oversight.
- Implement data management processes, guidelines, and SOPs; manage DM study team deliverables and escalations for poor vendor performance.
- Lead TMF data management oversight with CTM; maintain TMF files and perform quality checks.
- Support database lock/freeze activities; oversee EDC timelines for milestone deliveries.
- Participate in meetings/teleconferences; provide site/team training (incl. Agiloft/Netsuite processes as needed).
- Process department contracts/invoices; develop review/export tools and workflow work instructions.

Qualifications:
- BA/BS (preferably scientific/healthcare).
- 5+ years directly relevant experience.

Required/Preferred Skills:
- Strong track record as Lead Clinical Data Manager in pharma/biotech or CRO.
- Project management skills; ability to multitask.
- In-depth regulatory/industry standards knowledge (ICH/FDA, CDISC, GCDMP, 21 CFR 11, MedDRA, WHO dictionaries).
- Technical competency with DM/EDC systems; Medidata RAVE preferred.
- Oncology and Phase III/pivotal experience preferred.

Compensation:
- US Salary Range: $107,250 to $178,750