Provide leadership to manage and monitor clinical studies. Oversees and coordinate all aspects of ongoing clinical research study projects to ensure study requirements, FDA requirements and company objectives are achieved. Collaborate with clinical manager to ensure seamless integration of activities between the research department and the clinical department.
Key Results Area:
Provide a leadership role in managing/monitoring multiple clinical trials through all phases of the study life cycle
Responsible for coordinating clinical trial activities and creating status reports for all clinical trials being managed by the Clinical Research Department.
Subject matter expert on all matters related to clinical trials and provide analysis and direction to refine and improve.
Work with project managers to design, create protocols and all associated study documents for clinical studies. Once approved, Clinical Research Manager will collaborate with Lead Coordinator to implement and monitor clinical study progress.
Ensure that all aspects of GCP are complied with at all times through provision of training at start-up and initiation meetings for clinical trials and on-going SOP development.
Coordinate the smooth monitoring of all trials by identifying and managing qualified staff, establishing audit procedures and ensuring that cleaned data is entered into the database in a timely fashion.
Manage relationship with coordinators to determine that study design and protocols will meet the regulatory objectives outlined at the beginning of the study. Assist in the compilation/writing of and clinical sections to support regulatory filings as required.
Provide support to the clinical research staff to assist with data collection and formulating study output into summary form for presentation.
Other duties as required.
Knowledge of Federal Regulations and GCP, as applicable to the conduct and execution of medical device trials.
Demonstrated management of clinical trails
Proven ability to train and mentor staff
Outstanding communication skills, oral and written
Experience developing relationships with physicians and staff
Experience writing protocols
Education and Experience Requirements:
Bachelor’s degree in a scientific or healthcare field.
Industry Training and/or certifications (e.g., ACRP, SoCRA CCRP)
Training and experience in monitoring of clinical trials