We have a current opportunity for a Manager CDM on a permanent basis. The position will be based in Cambridge, Massachusetts. For further information about this position please apply.
Job Title: Manager, Clinical Data Management
Location: Massachusetts, USA | onsite position
Job Type: Full-time
Job Summary: We are seeking an experienced and detail-oriented Manager of Clinical Data Management to join our team. The successful candidate will oversee the data management activities for clinical trials, ensuring the integrity, accuracy, and security of clinical data. This role requires strong leadership skills, a deep understanding of clinical data management processes, and the ability to work collaboratively with cross-functional teams.
Key Responsibilities:
- Design and Implement Data Collection Systems: Develop and maintain efficient systems and tools for clinical data collection, ensuring compliance with regulatory standards.
- Data Management Oversight: Supervise the data management process, including data collection, entry, verification, and cleaning to ensure high-quality data.
- Regulatory Compliance: Ensure all data management activities comply with Good Clinical Practice (GCP) and other relevant regulatory guidelines.
- Collaboration: Work closely with investigators, biostatisticians, and other healthcare professionals to gather, interpret, and analyze clinical data.
- Documentation: Prepare and maintain comprehensive documentation, including data management plans, standard operating procedures (SOPs), and clinical study reports.
- Team Leadership: Train, mentor, and supervise data management staff, fostering a collaborative and productive work environment.
- Problem-Solving: Address and resolve data queries and discrepancies, ensuring data consistency and accuracy.
- Project Management: Manage timelines and deliverables for data management activities, ensuring project deadlines are met.
Qualifications:
- Education: Bachelor's degree in Life Sciences, Computer Science, or a related field. Advanced degree preferred.
- Experience: Minimum of 10 years of experience in clinical data management, with at least 2 years in a supervisory or managerial role within a CRO or pharmaceutical environment.
- Technical Skills: Proficiency in clinical data management systems (e.g., EDC systems), database management, and statistical software.
- Regulatory Knowledge: In-depth knowledge of GCP, FDA, and other regulatory requirements.
- Soft Skills: Excellent communication, leadership, and problem-solving skills. Ability to work effectively in a team-oriented environment.
