This position is responsible for managing and meeting the objectives of a clinical study. Duties include: maintaining and following proper ISO procedures and requirements; providing study management and ensuring successful conduct of assigned clinical programs; working with company's Clinical Director to determine the study objectives, strategy, scope and schedule in order to meet business needs; interfacing with regulatory agencies including pre-IDE meetings with the FDA and presentations to FDA reviewers regarding requirements and the results of the study; ensuring that adequate monitoring is conducted at all clinical trials; evaluating clinical data/information, providing interim and final reports, convening and directing investigator conferences to review findings and provide direction;
authoring/co-authoring the results of studies in medical literature and/or presenting at scientific meetings.
Qualifications:
Requires a technical Bachelor's degree in Engineering, Biological Sciences or a related Medical/Scientific field (Master's degree preferred), coupled with at least 3.5 years experience directly supporting clinical research or similar experience in a medical/scientific organization. Requires advanced written and oral communication skills, the ability to manage multiple tasks and a proficient knowledge of medical terminology. Must have expertise with GCPs and regulatory compliance in clinical trials, and possess advanced problem solving skills and knowledge of clinical outcomes, research and study design.
Back to Careers