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Clinical Research Project Manager
2 months ago
What are we seeking in our Clinical Trial Lead?
Russell Tobin & Associates is representing a prominent medical device manufacturing firm in search of a Clinical Trial Lead for a remote position.
Employment Type: Contract/Remote
Compensation: $65-$72/hr, based on experience
Key Responsibilities:
- Oversee clinical operations deliverables for client products.
- Direct clinical activities, guiding and managing the study team in alignment with business objectives, milestones, and timelines. Collaborate with Clinical Affairs management, Clinical Program Management, Clinical Science, Clinical Supply/Logistics, Compliance, and various functional teams (R&D, Biometrics, Medical Affairs) as well as external stakeholders (study investigators and research coordinators).
- Identify potential risks that may affect the overall project plan and initiate appropriate contingency strategies.
- Develop, revise, and contribute to the creation 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, and meeting materials (agendas and minutes).
- Facilitate functional strategy discussions, study meetings, and alignment sessions as necessary.
Qualifications:
- Extensive experience in all facets of clinical trial design and execution.
- A minimum of 8-12 years of relevant experience in the medical device, pharmaceutical, IVD, and/or CRO sectors.
- At least 5-8 years of experience leading clinical study preparation and monitoring, along with managing study teams.
- Comprehensive understanding of the processes involved in study preparation, management, and knowledge of Good Clinical Practices (GCPs), monitoring, clinical, and regulatory operations. Technical expertise in various aspects of the clinical evaluation process.
- A proven track record of significantly contributing to the success of planning and executing clinical strategies in support of product clearance.
Preferred Qualifications:
- Experience in diabetes-related projects.
- Background in the medical device industry, pharmaceuticals, biotech, and/or CRO.
- Familiarity with continuous glucose monitoring (CGM) is advantageous.
- Professional certifications (e.g., CCRA (ACRP), CCRP (SoCRA), PMP, ACRP, RAPS) are a plus.
Benefits Offered by Russell Tobin:
Russell Tobin provides eligible employees with comprehensive healthcare coverage (medical, dental, and vision plans), supplemental insurance options (accident insurance, critical illness insurance, and hospital indemnity), a 401(k) retirement savings plan, life and disability insurance, an employee assistance program, identity theft protection, legal support, auto and home insurance, pet insurance, and employee discounts with select vendors.
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Compensation: $65-$72/hr, based on experience
