Study Data Manager - Clinical Data Management (EDC)

Job Description

Job Description

Our client is seeking a Study Data Manager to oversee end‑to‑end data management activities for Phase I–IV clinical studies. This role ensures the accuracy, integrity, and regulatory compliance of clinical trial data from study startup through database lock. The Study Data Manager will serve as the primary Data Management representative on cross‑functional study teams and collaborate closely with Clinical Operations, Biostatistics, Programming, Medical Monitoring, and external vendors.

Onsite | No Visa Sponsorship | No Relocation Assistance

Contract Duration: 6 months | W2

Please Note: Candidates must live within a 15–60 minute commute of worksite

Responsibilities:

• Support audits, inspections, and submission readiness activities.
• Design, review, and validate eCRFs and database specifications.
• Track study metrics and provide regular updates to project teams.
• Reconcile external data sources (e.g., labs, imaging, ePRO, third‑party vendors)
• Perform User Acceptance Testing (UAT) for databases and system enhancements.
• Collaborate with cross‑functional partners to ensure data readiness for analysis.
• Contribute to process improvements and best practices within Data Management.
• Conduct ongoing clinical data review and manage data queries with sites and vendors.
• Lead database lock activities, including data cleaning, reconciliation, and quality control.
• Oversee EDC system setup, edit checks, data validation rules, and discrepancy management.
• Develop, review, and maintain study‑specific Data Management Plans (DMPs) and related documentation.
• Lead data management activities for assigned clinical studies in alignment with timelines, SOPs, and regulatory requirements.

Qualifications (Must-Haves)

• Experience supporting Phase I–IV clinical trials.
• Hands‑on experience with EDC and CTMS systems.
• Bachelor's degree in a science‑related field (or equivalent relevant experience)
• Minimum 4 years of pharmaceutical or biotech clinical data management experience.
• Working knowledge of ICH‑GCP, FDA regulations, CDISC standards, and clinical trial processes.
• Strong understanding of eCRF design, edit checks, data validation, discrepancy management, and database lock.

Preferred Skills:

• Experience or certification in EDC build.
• Familiarity with SAS or similar data analysis tools.
• Experience mentoring or supporting junior data management staff.