Clinical Trial Manager

Job ID: RDS08-01 Position Title: Clinical Trial ManagerWorking Location: NC, CaryEmployment Status: Full-TimeRequired Experience: 3 yearsRequired Education: Bachelors DegreeTravel Required: YesJob Description:Lead and manage the operational implementation of multiple clinical trials for one new drug development program. This position is directly responsible for all aspects of the initiation, maintenance and completion of clinical trials including the planning, tracking and support of assigned clinical studies/programs to ensure these are delivered on time and within scope/budget.Education:RN, BSN or a BS or MS in a scientific or health care field Experience:Minimum of three (3) years in clinical trial project management and three (3) years in clinical trial monitoring (e.g., CRA)Essential Skills:Details:• Lead matrix team to ensure on time delivery of clinical study completion. Assume the role of being directly responsible all aspects of the initiation, maintenance and completion of clinical trials, including the integration of Clinical Operations, Data Management, Statistics, Medical Writing and managing the project specific interfaces with Project Management, Regulatory and Pharmaceutical Development. • Serve as a single point of contact for CRO project manager; liaise with appropriate study conduct team members as needed.• Facilitate the development of clinical contracts by working closely with Legal, Finance, & Purchasing groups to develop requests for proposals, review proposals, and provide input regarding costs.•Review all clinical study invoices for accuracy against the contract.• Maintain the clinical study budget and provide budget forecasts to the Project Manager.• Manage all clinical study relationships and monitor performance of CROs and other vendors.• Identify issues and propose strategy to manage implications of clinical study progress upon overall timeline goals.• Develop clinical study timelines and clinical study conduct plans. Provide to Project Manager to include in the overall program development timeline.• Manage clinical study start-up, conduct, and close-out.• Ensure timely delivery of clinical study database lock.• Forecast clinical trial material needs.• Drive execution of clinical study investigator meetings (utilizing a CRO).• Provide status reports for program meetings and senior management.• Document clinical study meeting updates/actions..Additional Information: Travel Percentage: 10% Location: Cary, NC, Status: Full Time, Employee Career Level: Experienced (Non-Manager) Education Level: Bachelor's Degree Job ID: PCK425-5512