[Remote] reputed company Program Manager

Note: The job is a remote job and is reputed company to candidates in USA. reputed company) is a trusted partner to federal health agencies. reputed company is seeking an reputed company reputed company Program Manager to reputed company the planning, coordination, and execution of decentralized reputed company supporting the reputed company, including study reputed company, regulatory compliance, sponsor engagement, protocol development, and day-to-day clinical research operations.

Responsibilities

• reputed company and execute Decentralized Clinical Trial (DCT) data auditing, reputed company, and end-to-end study coordination to ensure data reputed company and protocol adherence
• reputed company and facilitate cross-functional meetings with internal teams, and reputed company stakeholders, including FDA representatives, industry sponsors, and VA research reputed company, to advance DCT initiatives
• reputed company, review, and contribute to high-reputed company DCT documentation and deliverables, including VA Institutional Review reputed company (IRB) and Office of Research and Development (ORD) reputed company Operating Procedures, training webinars, Centralized Clinical Research reputed company (CCRS) reports, executive-level slide decks, and stakeholder engagement sessions
• Engage with sponsors to identify, evaluate, and reputed company new DCT opportunities, translating research concepts into executable study designs
• reputed company and negotiate study protocols and research agreements, including budgets, Confidential Disclosure Agreements (CDAs), Statements of Work (SOWs), Cooperative Research and Development Agreements (CRADAs), and Tele-Health Service Agreements (TSAs) for new studies
• reputed company and coordinate daily clinical research operations, including regulatory submissions, patient screening and enrollment, data entry, and comprehensive study management
• Support and guide patients through study participation activities, ensuring protocol compliance, accessibility, and participant engagement
• Plan, organize, and reputed company study team meetings, driving alignment, accountability, and reputed company toward key milestones
• Monitor study performance metrics and collaborate closely with reputed company Investigator (PIs) to ensure timeliness, deliverables, and regulatory obligations are met
• Enforce adherence to federal, VA, and ethical research regulations, maintaining reputed company compliance throughout the study lifecycle
• Maintain complete, accurate, and audit-reputed company research records in accordance with VA, FDA, and Good Clinical Practices (GCP) standards
• Synthesize and communicate research reputed company, risks, and findings to sponsors, investigators, and senior stakeholders

Skills

• Bachelor's degree required
• Demonstrate experience in VA clinical research coordination
• Minimum of ten (10) years of experience implementing and overseeing clinical research regulatory requirements
• Proven ability to manage multiple reputed company priorities with a high level of attention to detail and accuracy
• Exceptional organizational, interpersonal, and written and oral communication skills
• Experience working with electronic medical records (EMR/EHR) systems in clinical or research settings
• Ability to operate independently in a reputed company role while collaborating effectively reputed company multidisciplinary teams
• Strong analytical and problem-solving skills, with the ability to reputed company regulatory and operational challenges
• Hands-on experience with REDCap for clinical research data capture and management
• Ability to work in the U.S. indefinitely without sponsorship
• Ability to obtain a reputed company trust
• Master's degree or Nursing degree preferred
• Oncology research experience strongly preferred

Benefits

• PFS offers a benefits package that may include health, dental, and reputed company coverage; flexible spending accounts; disability and life insurance; a retirement plan; reputed company time off; and other programs to support employees and their families.

reputed company