You'll be leadering and managing the clinical data management and safety teams and also supervise CDM managers, Clinical Safety and Coding manager, and other staff as needed. Also, work closely with top Leadership and Management team, to create and implement strategic direction, project plans, and initiatives throughout the organization.
- Bachelor’s degree in related field.
- 6+ years of experience in clinical research and data management.
- 4+ years is in a leadership or management role to drive Clinical Data Management practices.
- Experience with project management and change management.
- Experience with commercial clinical data management systems and/or EDC products.
- Advanced knowledge of clinical research, FDA, ICH, GCP, GCDMP, and related regulatory requirements and best practices.
- Graduate Degree in life sciences or related disciplines.
- 10+ years management experience in a clinical research organization.
- Organization strategic planning experience.
- Working knowledge of CDISC/CDASH, MedDRA coding, and Medidata Rave EDC.
If you're interested then call me at 949-266-6257 or send your resume to me at dhaval, sule@collabera, com