This is a remote position.
The Clinical Project Manager (CPM) is responsible for leading and managing all aspects of clinical trials from initiation through closeout. This includes ensuring that clinical projects are conducted in compliance with applicable regulatory requirements, company SOPs, timelines, and budget. The CPM will serve as the primary point of contact for cross-functional teams, vendors, and sponsors (if applicable), ensuring streamlined communication and timely issue resolution throughout the project lifecycle.
Key Responsibilities:
Develop, manage, and oversee clinical trial project plans including timelines, milestones, budgets, and resource allocation.
Serve as the primary liaison between internal teams, clinical research sites, CROs, vendors, and external partners.
Lead cross-functional team meetings and coordinate study activities such as site selection, study start-up, monitoring, and close-out.
Ensure adherence to GCP, ICH guidelines, regulatory standards, and company SOPs throughout study conduct.
Monitor progress against timelines and budget; proactively identify risks and implement mitigation strategies.
Oversee vendor performance and manage contract deliverables for CROs, central labs, data management providers, etc.
Track clinical trial metrics and prepare regular status reports for internal leadership and/or sponsors.
Support regulatory and audit readiness, including contributing to study documentation and inspection preparation.
Participate in protocol development, CRF design, and review of key trial documents (e.g., ICF, SAP, CSR).
Minimum Qualifications:
Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field (Master’s or PMP certification a plus).
Minimum of 5 years of experience in clinical research, including 2+ years in a project management role.
Strong understanding of GCP, ICH guidelines, and clinical trial regulatory requirements.
Proven ability to manage multi-site and/or global studies across various phases (Phase I–IV).
Excellent organizational, problem-solving, and leadership skills.
Strong interpersonal and written communication skills.
Proficiency with clinical trial management systems (CTMS), MS Project, and Microsoft Office Suite.
In addition to a dynamic and collaborative work environment, we offer a comprehensive benefits package to support our employees' well-being. Our benefits include paid holidays, Paid Time Off (PTO) policy, and medical insurance to ensure our team members have the flexibility and coverage they need. We believe in fostering a healthy work-life balance while providing the necessary support for professional and personal growth.