Remote - Clinical Trial Lead

A highly reputable medical device corporation is currently hiring a qualified Remote Clinical Trial Lead.

Position Summary:

• The Clinical Trial Lead (CTL) / Study Lead will establish, track and deliver clinical operations milestones
• The CTL / Study Lead will provide direction and leadership to the clinical operations study team and manage daily clinical operations management and execution
• CTL / Study 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.)

Essential Duties and Responsibilities:

• Execute clinical operations deliverables for company 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
• Function as a Subject Matter Expert where appropriate
• Work independently to manage all clinical tasks and deliverables with limited oversight
• Create and implement training programs and process improvements
• Assists management with departmental audits of clinical studies and procedures

Requirements:

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

Must have both types of experience below:

• Clinical trial design and preparation: Drafting/authoring 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)
• Clinical trial conduct and execution: Site management, site qualification, monitoring, and close out.

• Excellent interpersonal, verbal and written communication skills.
• Very strong computer proficiency including Microsoft Office Suite
• 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
• Strong interpersonal and communication skills
• Excellent organizational skills and attention to detail
• Ability to manage multiple priorities
• Experienced in the medical device industry, Pharma, BioTech and/or CRO
• Experienced in continuous glucose monitoring (CGM) is a plus
• Professional certification (e.g., CCRA (ACRP), CCRP (SoCRA), PMP, ACRP, RAPS)