The Manager of Field Clinical Monitoring oversees process excellence within the Clinical Affairs group related to Field Monitoring. In this key role, the Manager of Field Clinical Monitoring will establish and implement processes to ensure that clinical affairs monitoring activities are conducted consistently and in compliance with applicable internal SOP’s and study plans as well as industry regulations and standards. This position is also responsible for supporting clinical trials as required.
Duties and Responsibilities include the following
- Managing day-to-day operations of field based clinical monitors (employees and contractors)
- Performing quality control review on clinical trial documents to ensure accuracy, consistency, and completeness where possible
- Developing and reporting on study monitoring and site compliance related metrics
- Participating in the drafting and review of GCP related SOPs/instruction guidelines, including associated checklists, forms for document QC, TMF management and other related clinical QC processes
- Serving as expert to clinical operations and data management staff on day-to-day site GCP compliance issues/quality questions of high complexity and impact
- Acting as advisor to in-house and field based staff for follow-up internal and FDA audit actions
- Training of clinical monitors on new or revised compliance practices, policies, and SOPs
- Perform other clinical duties when requested
- Bachelor’s degree in health profession or science field. Advanced degree preferred
- A minimum of six years of clinical affairs experience in the pharmaceutical or medical device industry. Previous experience with field clinical monitoring and leading a clinical study strongly preferred
- Excellent written and oral communication skills
- Computer literacy, proficiency in MS Office, Excel, PowerPoint, etc.
- Excellent organizational skills and attention to detail
- Ability to manage projects and resources
Some travel would be required for training, monitoring responsibilities, and educational seminars. Ability to travel approximately 30%.