About the Role: We are looking for an Experienced Clinical Study Manager (CSM) to join our team. In this role, the CSM is focused on designing, planning, implementing, and managing the overall conduct, or particular elements, of clinical research projects. The goal of the CSM is to ensure compliance with the protocol and overall clinical objectives, as well as applicable SOPs and regulations. This position will be located in Flagstaff, Arizona, Phoenix, Arizona, Elkton, Maryland or Newark, Delaware with the possibility of a hybrid remote work arrangement, depending upon the responsibilities of the role and business needs.
Responsibilities:
- Coordinate the activities of interdisciplinary Gore team members in the planning, executing and closing of clinical studies.
- Develop and approve study-specific documents, tools, presentations and processes.
- Overall oversight of clinical studies including activities of site monitors, clinical vendors, review and approval of site visit reports, selection and coordination of DSMB / CEC / Steering Committees, and participation in site visits as necessary.
- Assist with the management of medical device distribution, receipt, use and return.
- Routinely review data / CRFs to ensure data integrity, accuracy and protocol compliance.
- Track and report progress of studies to applicable internal stakeholders, including patient screening, enrollment, data collection, adverse event documentation and reporting.
- Develop Study Reports and provide clinical portions for Regulatory submissions.
- Manage non-compliance for resolution and prevention.
- Participate in process improvement efforts.
- Maintain knowledge of industry and regulatory trends as required to meet business needs and perform the responsibilities of the position.
About the company
W L Gore & Associates, Inc. is an American multinational manufacturing company specializing in products derived from fluoropolymers.
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