International Pharmaceutical Company
The Manager, Clinical Operations serves as the project manager and/or local US project manager for selected phase I-III clinical trials. This includes investigator identification, selection, training and routine monitoring, vendor management, maintaining and negotiating vendor contracts, management of site budgets and payments, preparation and local adaptation of documents for regulatory submission, and participation in the development of clinical study protocols.
- Provides input into the clinical development program strategy and timelines including periodic reporting of status updates and budgets to upper management and project leads.
- Provides project management for clinical trials
- Takes part in vendor identification and selection. Provide oversight for vendors, including Clinical Research Organization and core laboratories.
- Prepare regulatory documents and provide local adaptation of global documents to meet local regulations.
- Liaises directly with investigative sites and ECs/IRBs to facilitate the submission, initiation and conduct of clinical projects, including contracts and budgets.
- Work to maintain high quality of clinical studies that meet ICH, Good Clinical Practice standards and local regulations.
- Four year degree in pharmaceutics, biologics, biomedicine, or other life science related field
- At least 3 years of late-stage (phase II and III) clinical development experience with proven record in management of multi-center clinical trials
- Excellent project management skills
- Ability to train and supervise site staff and CRAs
- Ability to work well within a project team
- Excellent verbal and written communication skills
- Good planning and organization skills