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Clinical Trial Lead
4 weeks ago
What are we looking for in our Clinical Trial Lead?
Russell Tobin's client, a leading medical device manufacturing company is seeking a Clinical Trial Lead to work remotely
Apply Now
Employment Type: Contract/Remote
Pay rate: $65-$72/hr, DOE
Responsibilities:
- Execute clinical operations deliverables for Client 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.
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
Nice to have:
- Diabetes experience
- Experience in the medical device industry, Pharma, BioTech and/or CRO
- Experience in continuous glucose monitoring (CGM) is a plus
- Professional certification (e.g., CCRA (ACRP), CCRP (SoCRA), PMP, ACRP, RAPS)
Benefits that Russell Tobin offers:
Russell Tobin offers eligible employee’s comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), a 401(k)-retirement savings, life & disability insurance, an employee assistance program, identity theft protection, legal support, auto and home insurance, pet insurance, and employee discounts with some preferred vendors.
#CB
Rate/Salary: $65-$72/hr, DOE
