This is a remote position.
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.
Pharmavise Consulting Corporation participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, Pharmavise is required to give you written instructions and an opportunity to contact Department of Homeland Security (DHS) or Social Security Administration (SSA) so you can begin to resolve the issue. For more information on E-Verify, please contact DHS at 888-897-7781 or through their website at dhs.gov/e-verify.
