Coordinate and monitor complex clinical and pre-clinical projects from initiation through delivery under the guidance of the Clinical Program Manager. 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. Contribute to proposal review, protocol development, and Clinical Research Organization (CRO) selection and management.
Management of CRO
Management 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.
Assist in 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.
Assist in the preparation of pre-IDE and IDE submissions and other interactions with the FDA.
Development of standard operating procedures in compliance with US and Intl GCP’S.
Execute on clinical program strategy as directed by Clinical Program Manager
Must be able to travel globally as business needs require, travel could be as much as 25% depending on business demands.
Physical requirements – regular office
The above is not intended to be an all inclusive list of responsibilities. Other activities may be assigned as required by management.
Proficient in the use of MS Office products and other technology to document data and provide reporting
Excellent written and oral communication skills.
Excellent attention to detail and accuracy
Excellent organizational skills.
Solid understanding of GCP.
Bachelor’s degree in Biology, Health Sciences or related field required
Minimum of 5 – 7 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
AngioDynamics, Inc. - 15 months ago