We are seeking an experienced Clinical Trial Project Manager (CPM) to lead cross-functional study teams in the execution of Phase I–IV clinical trials. The CPM is responsible for the overall operational management, planning, implementation, and close-out of clinical studies according to defined scope, timeline, budget, and regulatory standards.

This role acts as the central hub of communication between clinical study teams, Contract Research Organizations (CROs), vendors, investigators, and regulatory authorities to ensure high-quality data integrity and participant safety.

Key Responsibilities1. Project Management & Trial Leadership

- Drive the full lifecycle of clinical trials from study start-up through database lock, clinical study report (CSR) completion, and trial close-out.
- Develop, maintain, and execute comprehensive Project Management Plans (PMP) , cross-functional timelines, resource allocation, and milestone schedules.
- Lead cross-functional study team meetings (e.g., Clinical Research Associates, Data Managers, Biostatisticians, Medical Writers) to ensure operational alignment.
- Monitor project status against key performance indicators (KPIs) and drive proactive risk mitigation and contingency planning.

1. Vendor & Site Management

- Oversee selection, contract negotiation, onboarding, and ongoing performance management of third-party vendors and CROs.
- Coordinate site feasibility, selection, activation,



and investigator meetings alongside clinical site monitoring teams.
- Manage vendor Service Level Agreements (SLAs) and track performance metrics to ensure contractual deliverables are met on time.

1. Financial & Resource Management

- Manage multi-million dollar trial budgets, accurately track monthly project accruals, forecast expenditures, and review vendor invoices.
- Identify scope changes and steward the evaluation, negotiation, and implementation of vendor change orders.

1. Quality Assurance, Compliance & Inspection Readiness

- Ensure all trial activities comply with ICH-GCP, FDA/EMA regulations, local regulatory requirements, and company Standard Operating Procedures (SOPs).
- Maintain continuously updated Trial Master Files (TMF/eTMF) to preserve inspection readiness throughout the trial lifecycle.
- Manage protocol deviations, track Corrective and Preventive Action (CAPA) plans, and support internal audits or regulatory inspections.

Requirements & QualificationsEducation & Experience
- Bachelor’s Degree in Life Sciences, Nursing, Pharmacy, Healthcare Administration, or related scientific discipline (Master’s or PharmD preferred).
- 4–6+ years of direct experience in clinical trial operations within a CRO, biotechnology, or pharmaceutical company.
- Minimum 2+ years in a project management or trial management leadership capacity.
- Solid track record of managing multi-center or global Phase II–III clinical studies.

📌 Clinical Trial Project Manager (Noida)
🏢 Cosma Fertility
📍 Noida