The Clinical Trial Manager is responsible for the conduct and management of investigational studies in the clinical department. The position will be responsible for identifying, selecting, and closing out appropriate investigational sites for clinical studies. He/she will interact closely with other cross-functional areas involved in Clinical Development and will report directly into the Associate Director, Clinical Program Leader.
Responsible for the conduct of all investigational studies of Avid's molecular imaging agents, insuring adherence to FDA regulations, ICH GCP guidelines and Avid's internal SOPs
Manage all components of clinical trials from protocol inception through CSR completion. Includes staffing, writing and implementing protocols, site selection, designing CRF, data management plans, monitoring plans and training site staff, internal staff and monitors on protocol specific procedures
Maintain project timelines during the planning, initiation, ongoing/active and study completion stages of clinical trials
Supervise the selection of appropriate investigational centers to expedite the conduct of clinical studies. Conduct site qualification to assess the qualifications and capabilities of potential sites and investigators and conduct site initiation visits;
Manage the study budgeting process;
Negotiate clinical outsourcing vendor agreements including CRO, Central lab, ECG and electronic data capture as well as manage vendors with respect to contracted scope of work and budget
Serve as liaison between clinical operations and other functional areas
Design electronic data capture forms to insure proper data collection for all clinical study data
Demonstrate a commitment to developing around Avid's core competencies: cultivates innovation, drives engagement, ensures accountability, plans and aligns, nimble learning, and manages complexity
Other duties as assigned
Internal Number: 47998
About Eli Lilly & Company
Company Overview At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees worldwide work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.