Associate Director, Clinical Data Management

The Principal Trial Manager leads projects and initiatives to improve the quality and compliance of clinical data management functional areas, in addition to individual Trial Manager responsibilities. Accountable for successful execution of the clinical data management strategy for one or more drug or vaccine trials.

• Lead special projects and initiatives within GDMS.
• Act as SME, mentor, and trainer on data management, project management, and leadership.
• Support Training & Development programs to promote end-to-end Trial Manager proficiency.
• Support functional process owners (PO) with process implementation input as an SME.
• Partner with functional representatives to promote consistency in database standards and support trial design/peer review.
• Identify, define, and implement improvements to data collection and data/project management processes and tools.
• Support audits and inspections.
• Lead functional and cross-functional special project management and complex risk management.
• Perform all required activities outlined in the TM job description.

• B.A./B.S. in life sciences, computer science, or related field; at least 6 years Clinical Data Management (or mix of Data Management and Clinical Research) and at least 3 years working with formal project management tools/processes.

• End-to-end study life cycle accomplishments; strong knowledge of clinical development.
• Knowledge of applicable regulations/policies (e.g., GCP).
• Ability to work under pressure, independently, and with accountability.
• Coordinate others, drive decisions, exceptional communication, organizational/problem-solving/negotiation.
• Excellent project management and leadership; coach/mentor others; lead cross-functional initiatives with Quality/Compliance impact.

• Clinical Data Management, Clinical Data Standards, Data Management, Good Clinical Practice (GCP), project management leadership, strategic thinking, influencing, mentoring staff, detail-oriented.

• Cross-functional teamwork, decision making, deliverables management, leadership, leading project teams.