Clinical Trials Program Manager

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

📋 Description

• Oversee and implement data auditing for decentralized clinical trials, ensuring comprehensive study coordination from start to finish.

• Lead and facilitate cross-functional meetings with internal teams and external stakeholders, including representatives from the FDA, industry sponsors, and VA research groups.

• Draft, review, and contribute to documentation and deliverables related to DCT, such as VA IRB and ORD SOPs, training webinars, CCRS reports, executive-level presentations, and stakeholder engagement sessions.

• Collaborate with sponsors to discover, assess, and onboard new decentralized clinical trial opportunities.

• Transform research concepts into actionable study designs.

• Create and negotiate study protocols and research agreements, encompassing budgets, CDAs, SOWs, CRADAs, and TSAs.

• Supervise daily clinical research activities, which include regulatory submissions, patient screening and enrollment, data entry, and overall study management.

• Assist and support patients throughout their participation in studies.

• Plan, organize, and conduct meetings with the study team.

• Track study performance metrics and collaborate with Principal Investigators to ensure adherence to timelines, deliverables, and regulatory requirements.

• Uphold federal, VA, and ethical research standards throughout the study lifecycle.

• Maintain comprehensive, accurate, and audit-ready research records in accordance with VA, FDA, and GCP standards.

• Report on 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 system is essential.

• Strong preference for candidates with oncology research experience.

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

• Proven ability to manage multiple complex priorities with a keen eye for detail and accuracy.

• Outstanding organizational, interpersonal, written, and verbal communication skills.

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

• Capability to operate independently in a leadership position while collaborating effectively within multidisciplinary teams.

• Strong analytical and problem-solving capabilities.

• Practical experience using REDCap for clinical research data capture and management.

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

• Must be able to obtain a public trust clearance.

🏝️ Benefits

• Health coverage

• Dental coverage

• Vision coverage

• Flexible spending accounts

• Disability insurance

• Life insurance

• Retirement plan

• Paid time off

• Additional programs to support employees and their families