Senior Director, Clinical Data Management

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop and implement the global strategy for clinical data management.

• Enhance the data infrastructure to support scalability.

• Ensure comprehensive data integrity throughout all stages of clinical development.

• Plan and oversee the complete lifecycle of clinical data quality and integrity across all trials, including eCRF builds, edit checks, external data integrations, reconciliations, data cleaning, database locks, and preparation for submission.

• Create and expand a high-performing Data Management organization.

• Lead departmental performance initiatives, resource allocation, and the development of talent.

• Maintain compliance with global regulatory standards and internal Standard Operating Procedures (SOPs).

• Assist with regulatory audits and uphold inspection readiness.

• Foster cross-functional collaborations and represent Data Management in cross-functional discussions and enterprise initiatives.

• Manage relationships with Contract Research Organizations (CROs) to ensure timely and high-quality deliverables.

• Define quality metrics and establish governance frameworks.

⛳️ Requirements

• Over 10 years of experience in clinical data management within the pharmaceutical or biotechnology sectors.

• At least 5 years in a management position overseeing personnel.

• Experience handling large datasets from clinical trials.

• Demonstrated strategic leadership in data management throughout late-stage development programs.

• Proven track record of leading Data Management activities through successful filings with global health authorities (NDA, BLA, or MAA) and interactions with health authorities.

• In-depth knowledge of clinical trial data management, CDASH standards, executing database locks, external data reconciliation (eCOA, central labs, PK, etc.), inspection readiness, ICH, GCP, and internal SOPs.

• Capability to build, mentor, and retain high-performing teams.

• Expertise in overseeing global CROs, vendor management, and strategic outsourcing models.

• Advanced degree (Master) in Life Sciences, Statistics, Data Science, or a related quantitative area.

• E-Verify employment eligibility confirmation for new hires.

🏝️ Benefits

• Comprehensive health coverage.

• Flexible time off.

• Paid holidays.

• Year-end shutdown.

• Monthly wellness stipend.

• Generous 401(k) match.

• Tuition reimbursement.

• Commuter benefits.

• Disability insurance.

• Life insurance.

• Annual bonus opportunities.

• Equity grants.