Clinical Operations Lead

Responsibilities:

• Develop, manage, and oversee study plans, timelines, and project milestones to ensure smooth trial operations.
• Serve as the primary point of contact for external vendors, CROs, CRAs, and study sites throughout the clinical trial process.
• Train and oversee external vendors, such as CROs, CRAs, and laboratories, ensuring adherence to contracts and study requirements.
• Perform motivational site visits and technical visits, as well as support the medical team during device implantations.
• Monitor study progress, identify potential study challenges, and proactively develop and implement solutions to keep trials on track.
• Oversee the preparation and review of essential regulatory documents, including ICFs, CRFs, and study protocols and study conduct documents such as monitoring, training, and recruitment plans.
• Collaborate closely with data management, biostatistics, regulatory affairs, and R&D.
• Attend and present at investigator meetings and training sessions.
• Review monitoring reports and conduct co-monitoring visits, as needed.
• Ensure all clinical trial activities are conducted in accordance with GCP, FDA, EMA, and other applicable regulatory standards.
• Contribute to the preparation of study reports, presentations, and documentation for regulatory submissions and internal review, as well as assist in literature reviews.

Knowledge, Skills, and Abilities:

• Strong knowledge of GCP, FDA, EMA regulations, and overall clinical trial management best practices.
• Strong interpersonal communication, collaboration, and partnering skills, both written and spoken, with an ability to inform, influence, convince, and persuade.
• Proven ability to establish and maintain positive relationships with doctors, nurses, study coordinators, internal teams, CRAs, and external vendors.
• Strong ability to manage time and work independently.
• Analytical and technical approach, with the ability to collect, analyze, and interpret data to drive informed decision-making.
• Proficiency in Microsoft Office (Word, Excel, and PowerPoint).
• Travel approximately – up to 20% of the time

Education and Experience:

• BS/BA degree or a relevant degree with strong emphasis on science.
• Minimum of 6-8 years of experience in the device industry or other relevant clinical research experience in the conduct and management of multinational clinical trials.
• Excellent communication, organizational, and problem-solving skills.