Director, Clinical Operations

Role Summary

Director, Clinical Operations. Oversees planning, execution, and management of clinical trials to ensure regulatory compliance, timelines, and quality standards. Supports cross-functional teams, liaises with CROs, and ensures trials are conducted efficiently and ethically while maintaining patient safety.

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 clinical 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, including protocols, informed consent forms, study plans, and 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 patient retention objectives, and study budgets in support of trial execution.
• Contribute to writing and review of regulatory documents including IBs, ARs, INDs, and NDAs.
• Coordinate activities with cross-functional teams across multiple disciplines.
• Work with regulatory affairs to maintain and file regulatory documents.
• Manage and oversee vendor and CRO activities; track deliverables to stay within timeline and budget.
• Oversee construction and maintenance of TMF with vendors and ensure complete transfer to the company.
• Stay current with regulations and industry trends; input into processes to meet best practice standards.
• Communicate project issues and identify risks; collaborate with internal teams to resolve challenges.
• Assist in development of standard operating procedures.
• Remote position in the US, Northeast-based with travel as needed.

Qualifications

• Bachelor‚Äôs degree in a scientific discipline, RN, or equivalent. PMP preferred.
• 8‚Äì10 years of Phase 1‚Äì3 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.
• Self-discipline, motivation, and entrepreneurial spirit.
• Advanced knowledge of GCP, ICH, and FDA regulatory requirements.
• Ability to re-prioritize and work independently within a cross-functional team and with external vendors.
• Strong collaboration and interpersonal, oral, and written communication skills.
• Knowledge of Data Management and proficiency with CTMS and related software.
• Proficient in MS Office.
• Ability to travel 10% domestically and internationally.