Project Manager, Clinical Operations

Position Summary

The Clinical Operations Project Manager will be responsible for the day-to-day operational management and execution of HHP clinical studies.

The role will coordinate CROs, vendors, internal stakeholders, and study sites to ensure clinical trials are conducted efficiently, compliantly, and according to study timelines and quality expectations.

Key Responsibilities

• Manage day-to-day operational activities for assigned clinical studies.
• Coordinate study startup activities including site selection, feasibility, regulatory submissions, site activation, and vendor onboarding.
• Track study timelines, enrollment progress, milestones, risks, and action items.
• Serve as a primary operational contact for CROs, vendors, and study teams.
• Review monitoring reports, enrollment metrics, protocol deviations, and site performance data.
• Support management of study budgets, purchase orders, invoices, and vendor deliverables.
• Ensure study documentation and TMF are inspection-ready and maintained appropriately.
• Coordinate cross-functional meetings and follow-up actions across Clinical, Medical, Regulatory, QA, Biometrics, and Pharmacovigilance teams.
• Support development and review of study-related documents, including operational plans and vendor scopes of work.
• Identify operational risks and escalate issues proactively with proposed mitigation plans.
• Ensure compliance with ICH-GCP, regulatory requirements, and HHP SOPs.
• Support audit and inspection readiness activities.

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related field.
• Minimum 5+ years of clinical operations experience in biotech, pharmaceutical, or CRO industry.
• Experience independently managing clinical trial activities and CRO oversight.
• Experience with Phase I–III clinical trials preferred.
• Good understanding of ICH-GCP and clinical trial regulations.
• Strong organizational, communication, and project management skills.
• Ability to manage multiple priorities and work across global teams.
• Proficiency in CTMS, eTMF, and M365 Office tools.