Key Responsibilities
Team Leadership & Management:
- Lead, mentor, and develop a team of Clinical Data Managers and Senior CDMs.
- Manage resource allocation, workload distribution, and project assignments to ensure timely and high-quality deliverables.
- Conduct performance reviews, set objectives, and foster a culture of continuous improvement and excellence.
Project Oversight & Delivery:
- Provide senior-level oversight for all data management activities from study start-up to database lock across multiple projects.
- Review and approve key data management documents, including Data Management Plans (DMPs), Case Report Forms (eCRFs), Data Validation Specifications (UAT plans), and data transfer agreements.
- Ensure projects are delivered on time, within budget, and in compliance with protocol, SOPs, GCP, and regulatory guidelines (e.g., FDA, EMA).
Client & Vendor Management:
- Act as the primary data management contact for clients, building strong relationships and ensuring clear communication.
- Manage and oversee relationships with external vendors, including centralized laboratories and electronic data capture (EDC) providers.
Quality & Process Improvement:
- Ensure the quality and integrity of clinical data through the implementation of robust data review and cleaning strategies.
- Lead the development, review, and implementation of Standard Operating Procedures (SOPs) and best practices for the data management function.
- Host and manage sponsor audits and regulatory inspections related to data management.
Strategy & Contribution:
- Contribute to department strategy, including the evaluation and implementation of new technologies and systems (e.g., EDC, AI/ML tools).
- Participate in business development activities, including proposal development and bid defense meetings.
Qualifications & Experience
Essential:
- Bachelor's degree in Life Sciences, Pharmacy, Nursing, Statistics, Computer Science, or a related field.
- Minimum of 8 years of experience in clinical data management within a CRO or pharmaceutical/biotech industry.
- At least 5 years of direct line management or team leadership experience.
- Proven track record of successfully managing the data management process for multiple, complex clinical trials from start-up to database lock.
- Deep expertise with common EDC systems (e.g., Medidata Rave, Oracle Inform, Veeva CDMS) and data management tools.
- Strong knowledge of GCP, ICH guidelines, FDA 21 CFR Part 11, and other relevant regulatory requirements.
- Excellent understanding of medical terminology, CDISC standards (CDASH, SDTM), and the drug development process.
