Lead Clinical Trials Program Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead and implement auditing of Decentralized Clinical Trial data, ensuring oversight and comprehensive study coordination from start to finish.

• Facilitate and direct cross-functional meetings with both internal teams and external partners, which include representatives from the FDA, industry sponsors, and VA research groups.

• Contribute to, author, and review documentation and deliverables related to DCT, including VA IRB and ORD Standard Operating Procedures, training webinars, CCRS reports, executive slide decks, and stakeholder engagement sessions.

• Collaborate with sponsors to identify, assess, and onboard new DCT opportunities.

• Convert research concepts into actionable study designs.

• Develop and negotiate study protocols and research agreements, covering budgets, CDAs, SOWs, CRADAs, and TSAs.

• Manage daily clinical research operations, which involve regulatory submissions, patient screening and enrollment, data entry, and thorough study management.

• Support and assist patients throughout their participation in the study.

• Organize, plan, and lead study team meetings effectively.

• Track study performance metrics and work with Principal Investigators to adhere to timelines, deliverables, and regulatory obligations.

• Ensure compliance with federal, VA, and ethical research standards throughout the lifecycle of the study.

• Maintain complete, precise, and audit-ready research documentation that meets VA, FDA, and GCP standards.

• Summarize and convey research progress, risks, and findings to sponsors, investigators, and senior stakeholders.

⛳️ Requirements

• A Bachelor's degree is required.

• A Master's degree or Nursing degree is preferred.

• Experience in coordinating clinical research within the VA is essential.

• A strong preference for candidates with oncology research experience.

• At least ten (10) years of experience in implementing and overseeing clinical research regulatory requirements is necessary.

• Ability to manage multiple complex priorities while demonstrating attention to detail and accuracy is crucial.

• Exceptional skills in organization, interpersonal communication, as well as written and oral communication are required.

• Experience with electronic medical records (EMR/EHR) systems in clinical or research contexts is needed.

• Capability to work independently in a leadership role while collaborating within multidisciplinary teams is important.

• Strong analytical and problem-solving abilities are required.

• Hands-on experience with REDCap for clinical research data capture and management is essential.

• Must have the ability to work in the U.S. indefinitely without sponsorship.

• Ability to secure a public trust is required.

🏝️ Benefits

• Health, dental, and vision coverage.

• Flexible spending accounts.

• Disability and life insurance.

• Retirement plan.

• Paid time off.

• Additional programs designed to support employees and their families.