Coordinate and monitor complex clinical and pre-clinical projects from initiation through delivery. Serve as liaisons between research, marketing, operational departments, investigators, study coordinators, advisors and, key opinion leaders in order to ensure that all targets and requirements are met. Create and implement timelines and strategies for efficient (on schedule and within budget) clinical product development. Contribute to proposal review, protocol development, and Clinical Research Organization (CRO) selection and management.
Selection and management of Contract Research Organizations.
Preparation of study budgets and timelines.
Development of investigator brochures and study subject enrollment enhancement materials.
Development of investigational plans and clinical protocols.
Qualification and screening of investigational sites.
Negotiate investigational site contracts.
Coordinate investigational site training and investigator meetings.
Coordinate clinical study monitoring.
Preparation of final study reports.
Assist with the preparation of US and international regulatory submission for the conduct of clinical studies and the approval of new products.
Preparation of pre-IDE and IDE submissions and other interactions with the FDA.
Development of standard operating procedures in compliance with US and Intl GCPíS.
The above is not intended to be an all inclusive list of responsibilities. Other activities may be assigned as required by management.
Excellent written and oral communication skills.
Excellent organizational skills.
Solid understanding of GCP.
Minimum requirement of Bachelorís degree; RN is acceptable.
Minimum of 5 years experience in clinical study management to support medical device regulatory approval applications; Oncology experience highly desirable
Direct experience in the management of CROs and other service clinical research service providers
Previous supervisory experience desired.
State or Province