Director, Clinical Operations

An exciting Medical Device company is on the lookout for an experienced Director, Clinical Operations to join the team! This is a remote position across the US, with occasional travel to their sites on both the East and West Coast!

Responsibilities Include:

• Collaborate closely with the VP of Clinical Affairs and the management team to address all Clinical Affairs needs within the company strategically.
• Oversee the activities of the Clinical Research Organization (CRO) responsible for managing studies on the company's behalf.
• Ensure the successful execution of clinical trials.
• Develop and oversee annual, quarterly, and monthly objectives and budgets pertaining to clinical study operations.
• Identify, monitor, and address challenges encountered during trials, keeping all stakeholders informed.
• Contribute to the development and oversight of the department's annual budget.
• Ensure compliant management of Trial Operations including oversight of the trial master file, electronic data capture (EDC) systems, data management, IRB submissions, contract negotiations, budget management, weekly site reporting, data analysis, and site materials.
• Lead and support the Trial Team, fostering motivation, engagement, and development through regular one-on-one meetings and clinical and device training.
• Provide leadership to trial sites by motivating, monitoring, and training site staff, and fostering engagement with principal investigators, investigators, and coordinators through regular communication, monthly calls, site visits, and ongoing support.

Requirements:

• Possess over 15 years of clinical operations experience, including more than 5 years in leadership roles overseeing clinical trials with medical devices in both European and US contexts.
• Demonstrate proficiency in engaging with diverse stakeholders, including board members, investors, prominent clinical leaders, and regulatory authorities.
• Skilled in cultivating and nurturing relationships with vital external partners such as physician advisors, professional associations, and hospital administrators.
• Willingness to travel frequently to clinical sites and conferences as necessary to support project objectives.
• A bachelor's degree is a prerequisite for this role.

If this sounds like the role for you or you are eager to learn more, please apply now!