Job Description

Job Title : Clinical Project Manager

Reports to : Director, Clinical Operations

We are seeking a highly organized and experienced Clinical Project Manager (CPM) to oversee and lead clinical research projects from initiation through completion. The ideal candidate will possess a deep understanding of the clinical trial process, strong leadership and financial management skills, and the ability to manage multiple stakeholders, budgets, timelines, and regulatory requirements. The CPM will work closely with a cross-functional team and will partner with internal and external team members/key stakeholders, ensuring alignment of activities with study projects and timelines to ensure the successful execution of studies in compliance with GCP, regulatory guidelines, and company standards.

Responsibilities

Project Planning and Execution

• Identify key milestones and deliverables, ensuring alignment with study goals and timelines
• Lead planning, initiation, execution, and closure of clinical studies, ensuring all activities are completed on time, within budget, and with a high level of quality
• Develop and manage project plans and timelines, identifying and addressing potential roadblocks
• Coordinate cross-functional team efforts to ensure seamless execution of clinical trials
• Ensure proper management of study site selection, initiation, monitoring, and closure activities

Stakeholder Management

• Serve as the primary point of contact for internal and external teams, CROs, and vendors
• Facilitate project meetings, provide updates, and manage expectations of stakeholders regarding timelines, deliverables, and risks
• Communicate project status, challenges, and issues to senior management ensuring timely resolution of concerns

Regulatory Compliance and Quality Assurance

• Ensure all studies comply with applicable regulatory requirements (FDA, EMA, ICH-GCP, etc.)
• Oversee preparation and submission of regulatory documents, including protocols, amendments, informed consent forms, and annual progress reports
• Monitor adherence to study protocols and GCP guidelines, ensuring the highest level of patient safety and data integrity

Budget and Resource Management

• Manage and track project budgets, ensuring proper allocation and utilization of resources
• Monitor expenditures and ensure that projects are completed within financial constraints
• Support negotiation of contracts and agreements with external vendors, CROs, and sites

Risk Management

• Proactively identify and assess project risks, including delays, budget overruns, regulatory challenges, and data quality concerns
• Develop and implement risk mitigation strategies to address potential issues and ensure smooth project implementation

Documentation and Reporting

• Ensure that all project documentation is complete, accurate, and up to date, including study protocols, regulatory documents, study reports, and meeting minutes
• Conduct periodic reviews of TMF to ensure audit readiness
• Prepare and present regular project updates to senior management
• Ensure proper documentation of study changes, deviations, and corrective actions
• Assist in the management of clinical studies, ensuring they are conducted in compliance with the agreed study plans through CRO and/or investigator site contact

Qualifications

Education and Certification

• Bachelor's degree in Life Sciences, Clinical Research, or related field; advanced degree preferred
• Relevant certifications (e.g., Project Management Professional (PMP), Clinical Research Coordinator (CRC), Clinical Research Associate (CRA)) preferred

Experience

• Minimum of 5 years of experience in clinical project management in a pharmaceutical, biotechnology, or CRO setting
• Proven track record of managing multiple, complex clinical trials across different phases
• Experience with regulatory requirements and industry standards (GCP, ICH, FDA, EMA)

Skills and Competencies

• Strong leadership and interpersonal skills, with the ability to lead and manage cross-functional teams
• Excellent organizational skills and attention to detail
• Strong financial management, budgeting, and resource allocation skills
• Effective communication and problem-solving abilities
• Ability to manage multiple priorities and work under pressure to meet deadlines
• In-depth knowledge of clinical trial processes, regulatory guidelines, and GCP
• Proficiency with clinical trial management systems (CTMS) and other relevant software
• Ability to work independently and collaborate effectively with external stakeholders

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