Project Manager-Clinical Trails

QPS Bioserve India; Hyderabad; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

QPS Bioserve India in Hyderabad is seeking an experienced Clinical Trial Project Manager to lead end-to-end late-phase studies from initiation to close-out, ensuring on-time delivery, quality, and budget adherence.

You will coordinate across Clinical Operations, Data Management, Biostatistics and Regulatory Affairs, manage sites and vendors, monitor recruitment and milestones, and mitigate risks with proactive planning.

Qualifications

• Hands-on experience in managing clinical trials from start to close-out.
• Strong cross-functional coordination and stakeholder management.
• Expertise in timelines, budgets, risks, and study delivery.
• Familiarity with ICH-GCP and regulatory requirements.

Responsibilities

• Lead and manage clinical trial projects from initiation through completion.
• Develop and maintain detailed project plans, timelines, milestones, and study trackers.
• Manage study start-up activities including feasibility, site activation, regulatory submissions, contracts.
• 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 for timely 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 effective resource planning and allocation across the project.
• Manage project budgets, forecasts, invoices, and financial tracking where applicable.
• Ensure communication with sponsors, investigators, vendors, and internal stakeholders.

Skills

Clinical Trial PM

Late-Phase Trials

Cross-Functional Coordination

Stakeholder Management

Tools

CTMS

MS Excel

PM Tools

Job description

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 good exposure to multiple functions within clinical development, would be preferred.