Director, Clinical Operations

Role Summary

Director, Clinical Operations. Oversee planning, execution, and management of global clinical trials to ensure regulatory compliance, timelines, and quality standards. Coordinate with cross-functional teams and CROs to ensure ethical and efficient trial conduct with patient safety at the forefront.

Responsibilities

• Support the design, planning, initiation, execution, and closeout of global clinical trials.
• Coordinate clinical trial operational activities to ensure completion according to project timelines and budget.
• Ensure trials are conducted in compliance with SOPs, GCP/ICH, and regulatory requirements; collaborate with Quality Assurance on site audits.
• Develop, manage, and review clinical trial documentation (protocols, informed consent forms, study plans, reports).
• Ensure collection, management, and reporting of trial data meet high quality standards.
• Identify and resolve issues related to trial data, patient recruitment and retention, and site performance.
• Manage trial timelines, enrollment and retention objectives, and study budgets.
• Contribute to writing and review of regulatory documents (IBs, ARs, INDs, NDAs).
• Coordinate activities with cross-functional teams (Regulatory Affairs, CMC, etc.).
• Work with regulatory affairs to maintain and file key regulatory documents.
• Manage vendor and CRO activities; track deliverables to stay on timeline and budget.
• Oversee TMF construction and maintenance with vendors and ensure transfer to the company.
• Stay current with regulations and industry trends; provide process improvements to meet standards.
• Communicate project issues and emerging risks; collaborate to resolve challenges.
• Assist in developing standard operating procedures.
• Remote position US, Northeast based with travel as needed.

Qualifications

• Bachelor’s degree in a scientific discipline, RN, or equivalent. PMP preferred.
• 8-10 years of Phase 1-3 global clinical trial operations experience.
• Demonstrated experience running sponsor-based late-stage clinical trials.
• Experience managing external vendors/CROs.
• Experience in cardiovascular disease strongly preferred.
• Strong self-discipline, motivation, and entrepreneurial mindset.
• Advanced knowledge of GCP, ICH, and FDA regulatory requirements.
• Ability to re-prioritize, work independently, and collaborate with cross-functional teams and external vendors.
• Excellent interpersonal, oral, and written communication skills.
• Knowledge of Data Management and proficiency with CTMS and related software.
• Proficient in MS Office (Outlook, Word, PowerPoint, Excel).
• Ability to travel 10% domestically and internationally.

Education

• Not specified beyond qualifications above.