Study Director - Medical Devices
Employment Type: Full-Time
Industry: Healthcare - Allied Health
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Job Overview: We have a great opportunity for a STUDY DIRECTOR specializing in medical devices to join our team in San Carlos, CA. Covance's work in developing new pharmaceutical solutions has an incredible impact on millions of lives worldwide. Be a part of this life-saving work. In this role, the Senior Study Director will: + Serve as a Study Director for a wide range of safety and efficacy studies for medical devices, as described in the GLPs. Has overall responsibility for the technical conduct of a study as well as for the interpretation, analysis, documentation, and reporting of results. + Develops protocols and ensures that the protocol, including any changes, is approved and is in compliance with the appropriate SOPs, GLPs, and regulatory agency guidelines. + Works with veterinarians, project management, and study direction to evaluate proposals, evaluate feasibility, and provide recommendations to clients. + Follows GLP and other regulatory requirements to ensure the acceptability of Covance data. + May monitor financial status of ongoing studies and programs. + Monitors progress and status of assigned studies and research projects. Ensures that all experimental data, including observations of unanticipated responses to the test system, are accurately recorded and verified. + Directs analysis of data, preparation of reports, ensures compliance with protocol and regulatory requirements, and submits them to the client. + Joint leader/host in client visits. + Provides a leadership role or may assist in troubleshooting and solving challenging technical problems, dependent on issue and site. + Directs and conducts both fundamental and complex medical device studies. + Lead the scientific interpretation of study data, consulting the relevant scientific stakeholders in Operations, Pathology, CPS, BioAnalytical, TK, and other applicable groups, ensuring all data are accurately interpreted. + May author scientific papers, which are published in peer reviewed journals, and presented in scientific meetings. Performs scientific mentoring activities (e.g.; training study related processes, assisting with complex analytical work/problem solving, and presenting seminars). + Attends local medical device seminars for continuing education and client outreach as well as developing new client relationships. + Contributes to long-range planning and technical policies of the department. + Keeps management informed of problems/issues as they unfold in assigned studies. What we're looking for in you: + PhD in toxicology or related subject, DVM or equivalent degree. Relevant experience may be substituted for education. + Five to seven years of related experience. + Diplomate, ABT certification desirable. + Recognized expertise preferred. + Maintains current regulatory awareness (domestic and foreign), in the field of speciality. + Highly skilled in conducting research, data interpretation, and writing reports. + Highly skilled in performing scientific presentation and preparing scientific publications. There is no better time to join us! #LI-TC1 Education/Qualifications: PhD in Biomedical Engineering or related field preferred, BSc or MSc or equivalent degree in toxicology or related field. Experience Relevant experience may be substituted for years of related experience. Experience: 3 to 5 years of safety assessment study direction experience and medical device experience
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us. </script>
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