Eastridge Workforce Solutions is hiring a Clinical Trial Lead for a top medical equipment manufacturing company. Our San Diego, CA client is a leader in transforming diabetes care and management by providing CGM technology to help patients and healthcare professionals better manage diabetes. For immediate consideration, apply today.

The Clinical Trial Lead (CTL) / Study Lead will establish, track and deliver clinical operations milestones. They will provide direction and leadership to the clinical operations study team and manage daily clinical operations management and execution. The Lead is the single point of accountability for all stages of clinical operations activities, from early study design, start-up, active study, and close-out. Candidates will have extensive prior experience in similar role with proven track records of successful clinical study completion with adherence to timelines, budget, and milestones. Candidates will have in-depth knowledge of applicable clinical research guidelines and regulations, as well as software, tools, and systems used in clinical conduct (e.g., CTMS, eCRF, TMF, etc.)

Responsibilities:

• Execute clinical operations deliverables for Dexcom products
• Lead clinical activities, directing, and leading the study team as above in alignment with business goals, objectives, milestones, and timelines
• Collaborate with Clinical Affairs management, Clinical Program Management, Clinical Science, Clinical Supply/Logistics, Compliance, and the various functional groups (R&D, Biometrics, Medical Affairs) as well as external contacts (study investigators and research coordinators)
• Identify risks that may impact the overall project plan and initiate contingency plans as appropriate
• Develop/Revise and/or provide input in the development of clinical trial related documents including but not limited to: 
• Study protocols, training materials, case report forms, informed consents, IRB submissions, source documents, timelines, clinical monitoring plans, reference manuals, supply listings, monitoring tools, presentations, meeting materials (agenda and minutes).
• Lead functional strategy discussions, study meetings, and alignment meetings as needed
• Create and implement training programs and process improvements
• Assists management with departmental audits of clinical studies and procedures

Requirements:

• Extensive experience in all aspects of clinical trial design and execution
• Minimum of 8-12 years related experience in a medical device, pharmaceutical, IVD, and/or CRO
• Minimum of 5 - 8 years of leading clinical study preparation and monitoring and leading study team
• Thorough understanding of the processes associated with study preparation, study management, knowledge of Good Clinical Practices (GCPs), monitoring, clinical, and regulatory operations
• Technical expert in the various aspects of the clinical evaluation process
• History of significant contribution to the success of planning and executing clinical strategies in support of product clearance

Travel Required:

• The job may require travelling up to 25%-30% of the time as needed; some international travel may be required

Experience and Education:

• Bachelor’s, Master’s, or PhD degree in a technical / scientific discipline and a minimum of 8-12 years related experience in a medical device, pharmaceutical, IVD, and/or CRO  
• Minimum of 5 - 8 years of leading clinical study preparation and monitoring and leading study team

Benefits: Use this link bit.ly/2023-Benefits to learn more about benefits available to Eastridge’s temporary employees. From time to time Eastridge’s clients may offer additional benefits to Eastridge employees while on assignment. Information about those benefits will be communicated when applicable.

Eastridge Workforce Solutions is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We celebrate diversity and are committed to creating an inclusive environment for all employees. Please note that Eastridge is unable to provide visa sponsorship to applicants.

We value diverse experiences, including prior contact with the criminal legal system, and applicants with criminal histories are encouraged to apply. Certain clients require Eastridge to perform background checks and Eastridge will consider qualified applicants with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.

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