SUMMARY OF POSITION:
The Clinical Trial Manager (CTM) is responsible for the management of all clinical operational activities at the study and site level for assigned clinical projects. The CTM leads internal cross-functional teams and manages the Sponsor relationship with vendors and CROs to ensure successful execution of clinical studies.

ESSENTIAL FUNCTIONS:
1. Develops and coordinates clinical study and operations activities and manages their execution to ensure completion according to project timeline and budget. Reviews/edits protocols, amendments, Case Report Forms (CRFs), and clinical study reports. Develops documents and instructional materials in support of study execution, including project, communication, monitoring, recruitment and contingency plans.
2. Coordinates and leads cross-functional teams from multiple internal departments, closely oversees vendor and CRO activities, and tracks internal and external (CRO/vendor) project deliverables to ensure they remain within the timeline and budget.
3. Ensures internal and external CRAs assigned to project are trained on the protocol and relevant SOPs, reviews monitoring visit reports, accompanies CRAs on site visits, and initiates/follows up/tracks significant or relevant project issues at investigative sites. Ensures study execution compliance with GCP/ICH and regulatory requirements and works cooperatively with Quality Assurance with respect to site audits.
4. Coordinates the inspection, selection and auditing of investigative sites, plans for and presents at Investigator Meetings, develops other site training materials and subject recruitment strategies.
5. Actively communicates project issues and identifies emerging risks, then works with internal governance team of director-level (and above) multidisciplinary drug development professionals to resolve project challenges.

MINIMUM REQUIREMENTS:

Education: BSN/RN, or 4-year degree in a science background

Experience: Minimum of 5 years of clinical research experience. Previous monitoring, study coordination, data management and/or clinical project management experience including vendor/CRO management is required. Experience with opioid analgesics late stage studies a plus. Phase 2-3 experience necessary, and osteoarthritis experience highly desirable.

Preferred Skills/Qualifications: Knowledge of cGCP, ICH and FDA regulatory requirements. Strong project management, analytical and problem solving skills. Ability to manage, motivate and develop people. Travel as needed to resolve field issues and meet with partners and CROs.