Hologic Clinical Research Manager - Cynosure in United States
Clinical Research Manager - Cynosure
Post Date Mar 02, 2018
Provide leadership to manage and monitor clinical studies. Oversees and coordinate all aspects of ongoing clinical research study projects to ensure study requirements and FDA requirements and company objectives. Coordinate with project managers to manage all aspects of ongoing clinical research study.
Key Results Area:
Provide a leadership role in managing/monitoring multiple clinical studies to support product needs throughout the product life cycle
Responsible for coordinating clinical study activities and creating status reports for all clinical studies being managed by the Clinical Development Department.
Subject matter expert on all matters related to clinical research studies 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 project manager 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.On an as needed basis Clinical Research Manager may also directly coordinate clinical study sites depending on the need/relationship with the research coordinator at the study site.
Manage relationship with Cynosure's regulatory department 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 associates to assist with data collection/analysis from sites 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
- May manage direct and indirect personnel
Behavioral and Interpersonal:
Ability to manage tasks on multiple projects concurrently
Ability to work well independently in the medical setting, as well as a member of an integrated team in-house
Education and Experience Requirements :
Bachelors degree in a scientific or healthcare field.
Registered Nurse preferred
Industry Training and/or certifications (e.g., ACRP, SoCRA CCRP)
3 to 5 years of experience in medical device field
Training and experience in monitoring of clinical trials