The ideal candidate should have hands-on experience in managing clinical trials from Clinical Study start through study close-out, with strong exposure to cross-functional coordination, stakeholder management, timelines, budgets, risks, and overall project delivery.

Key Responsibilities

- Lead and manage clinical trial projects / late-phase clinical trials from initiation through completion, ensuring delivery within agreed timelines, quality standards, and budget.
- Develop and maintain detailed project plans, timelines, milestones, and study trackers.
- Manage overall study start-up activities, including feasibility, site identification/selection, regulatory submissions, contracts, and site activation.
- Coordinate with Clinical Operations, Data Management, Biostatistics, Medical Writing, Pharmacovigilance/Safety, Regulatory Affairs, Quality, and other cross-functional teams.
- Manage and monitor clinical sites, vendors, and external stakeholders to ensure timely and quality execution.
- Provide oversight of patient recruitment, Enrollment, retention, monitoring, data collection, and study close-out activities.
- Identify, assess, and manage project risks, issues, dependencies, and mitigation plans.
- Ensure appropriate resource planning and allocation across the project.
- Manage project budgets, forecasts, invoices, and financial tracking, where applicable.
- Ensure effective communication with sponsors, investigators, vendors, and internal stakeholders.
- Ensure clinical trial activities are conducted in compliance with ICH-GCP, applicable regulatory requirements, SOPs, protocols, and quality standards.
- Support identification, documentation,



and resolution of protocol deviations, quality issues, audit/inspection findings, and CAPAs.
- Oversee clinical trial documentation and TMF completeness in collaboration with relevant teams.
- Prepare and present executive-level project updates, highlighting progress, risks, issues, decisions required, and action plans.
- Ensure effective study close-out and transition to final reporting / database lock / CSR activities, as applicable.

Required Experience & Skills

- Strong experience in Clinical Trial Project Management, preferably with exposure to Late-Phase / Phase III / Phase IV trials.
- Comprehensive understanding of the end-to-end clinical trial lifecycle.
- Good knowledge of clinical operations and cross-functional clinical development activities.
- Experience managing vendors, investigators, and multiple internal stakeholders.
- Strong understanding of ICH-GCP and applicable clinical research regulations.
- Proven experience in project planning, risk management, issue resolution, resource management, and stakeholder management.
- Strong communication, leadership, presentation, and interpersonal skills.
- Ability to manage multiple projects/priorities in a fast-paced environment.
- Strong analytical and problem-solving capabilities.
- Experience with clinical trial management systems and project management tools is preferred.

Preferred Profile

Candidates with end-to-end clinical trial project management experience, particularly those who have managed Late-Phase/Phase III/Phase IV studies and have positive exposure to multiple functions within clinical development, would be preferred.

📌 Project Manager-Clinical Trails (Hyderabad)
🏢 QPS Bioserve India
📍 Hyderabad