Project Manager-Clinical Trails

QPS Bioserve India; Hyderabad; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

QPS Bioserve India is seeking a seasoned Clinical Trial Project Manager to lead late-phase trials from initiation to close-out. The role requires strong cross-functional coordination, stakeholder management, and delivery within timelines and budgets.

You will develop detailed project plans, manage start-up activities, site activation, regulatory submissions, and contracts, and oversee patient recruitment and data collection. Experience with ICH-GCP and SOPs is essential.

Qualifications

• Strong experience in Clinical Trial Project Management.
• Exposure to Late-Phase / Phase III / Phase IV trials.
• Understanding end-to-end trial lifecycle.
• Proven ability to coordinate cross-functional teams.
• Knowledge of ICH-GCP and regulatory requirements.
• Experience with project planning, risk management, and resource management.
• Excellent communication and leadership skills.

Responsibilities

• Lead and manage clinical trial projects from initiation through completion, on time and within budget.
• 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, Regulatory Affairs, Quality, and others.
• Monitor sites, vendors, and external stakeholders to ensure quality execution.
• Oversee patient recruitment, enrollment, retention, data collection, and study close-out.
• Identify and mitigate project risks, issues, dependencies.
• Ensure resource planning and allocation across the project.
• Manage project budgets, forecasts, invoices, and financial tracking.
• Ensure effective communication with sponsors, investigators, vendors, and internal stakeholders.
• Ensure adherence to SOPs, protocols, and quality standards.
• Support CAPAs, deviations, audit findings resolution.
• Oversee TMF completeness and study documentation.
• Prepare executive-level project updates with progress, risks, decisions, actions.
• Oversee study close-out and transition to CSR/reporting.

Skills

Clinical Trial PM

Late-Phase Trials

End-to-End Lifecycle

Cross-functional Coord

Stakeholder Mgmt

Budgeting & Forecasting

ICH-GCP Knowledge

Regulatory Compliance

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.