Description
Position PurposeIndependently manage multiple Phase 3 international trials; select and manage CRO and vendor teams; contribute to protocol development, study planning; oversee and track study budgets. Report to Manager, Clinical Operations (or higher).
Responsibilities
- Contribute to CRO and vendor identification and selection process;
- Contribute to management of CROs and other study partners (monitoring, data management, labs) for assigned trials;
- Contribute to development and management of vendor and investigator budget and payment process;
- Oversee study activities (investigator recruitment, start-up, enrollment, monitoring, data collection, reporting);
- Prepare study progress updates;
- Develop study documents including protocols, amendments, CRFs, ICFs, and other study documents;
- Organize and develop materials for investigator, expert, and other meetings;
- Contribute to clinical SOP development; and
- Travel an estimated 50% of the time (or as needed).
Qualifications
- BS in Life Sciences/RN or a related discipline or equivalent with minimum of 5 years industry experience in clinical trial execution and management (e.g. monitoring, data management, regulatory, contracts, and technical writing);
- Familiarity with international trials and Phase I-III desirable;
- Solid knowledge of GCPs and ICH guidelines;
- Experience working with CROs;
- Experience in study budget development a plus;
- Computer proficiency;
- Excellent written and verbal communication skills; and
- Energetic, positive, flexible, team-oriented, and interested in professional growth
To find out more about Real Staffing please visit www.realstaffing.com