PHYSICAL AND MENTAL REQUIREMENTS, WORKING CONDITIONS

• Learn new tasks, remember processes, maintain focus, complete tasks independently, make timely decisions in the context of a workflow, ability to communicate with others, ability to complete tasks in situations that have a speed or productivity quota.
• Travel up to 25%.
• Sedentary work. Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects. This position requires close visual acuity to perform activities such as preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading.
• This position requires the ability to identify and resolve quality issues.

ABOUT THE ROLE

The Director, Clinical Development Operations will oversee the planning and execution of clinical trials, including biopharma partnerships, investigator-initiated studies, and Foresight-sponsored studies under IDE and ISO regulations and GCP guidance. This role will work collaboratively with Medical Affairs, Quality Assurance, Regulatory Affairs, and the Production clinical laboratory as well as with external stakeholders such as the biopharma partners, clinical research organizations, clinical investigators, and ethics committees. Periodic travel may be required.

WHAT YOU WILL DO

• Manage the clinical operations team of Clinical Study Managers, Clinical Research Associates, Research Project Coordinators, and Data Managers in the successful execution of clinical trials.
• Lead biopharma partnerships through feasibility and due diligence to study start-up and execution, meeting all contractual obligations, milestones and deliverables.
• Support clinical operations team members in the implementation of clinical study protocols and operational plans, which are consistent with strategic corporate objectives.
• Coordinate clinical study timelines with cross-functional teams to meet critical milestones; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues.
• Oversee and execute clinical operations activities related to laboratory testing for biopharma partnerships, including:
• In-house monitoring of source and laboratory data;
• Manage and resolve biospecimen or data issues with Sponsor, CRO, or other study partners; and
• Monitor and report adverse device effects.
• Oversee and execute clinical operations activities for prospective, sponsored trials, including:
• Site and trial-level budget development
• Site feasibility evaluation and site activation
• Oversight of trial conduct, including monitoring
• Site and trial close-out
• Oversee and execute IRB submissions and applicable regulatory submissions (e.g. adverse device event reporting).
• Oversee TMF set-up and maintenance for all new and on-going studies.
• Maintain and update clinical operations documents that govern trial conduct.