Clinical Project Manager

Job Description:

The Clinical Project Manager will be responsible for managing individual or multiple clinical trial projects, ensuring that all objectives are met according to sponsor requirements and timelines. This role requires strong communication, problem-solving, and project management skills to maintain effective relationships with stakeholders, including sponsors, site teams, and internal departments. The CPM will also ensure compliance with regulatory guidelines and clinical operations standards throughout the project lifecycle.

Key Responsibilities:

• Demonstrate expert knowledge of ICH-GCP guidelines and local/regional regulatory requirements. Provide training and guidance to the project team on these standards.
• Manage all aspects of clinical trial projects, ensuring adherence to timelines, budget, and regulatory standards. Identify potential issues early and implement corrective actions as necessary.
• Oversee the creation and maintenance of study-related documentation, including trip reports, follow-up letters, and study status reports. Ensure quality and compliance across all documents.
• Act as the primary liaison between the sponsor, internal teams, and external partners (e.g., vendors, sites). Ensure clear and timely communication across all levels.
• Assist the Senior Clinical Project Manager (Sr.CPM) with team coordination, including monitoring schedules, site visits, and team training. Ensure all tasks are completed within project timelines.
• Identify and assess risks early in the project lifecycle, develop contingency plans, and execute them as necessary to ensure smooth project delivery.
• Provide training and mentoring to junior staff, including Clinical Research Associates (CRAs) and other project team members, to foster professional growth and improve team performance.
• Participate in client meetings and teleconferences, ensuring that client expectations are met. Assist in bid defense meetings and support the development of project-related documentation.
• Contribute to budget planning and tracking, ensuring that resources are appropriately allocated and expenditures stay within approved limits.
• Lead preparation for audits (internal, external, sponsor), ensuring compliance and addressing any issues identified.
• Be prepared to travel 30-50% of the time (domestic and international) to meet business needs, site visits, and client meetings.

Required Education/ Experience

• Bachelor’s or Master’s degree in Life Sciences, Medicine, Pharmacy, or a related field.
• Clinical Research certification/diploma is preferred.
• 7-9+ years of industry experience in clinical research, with at least 1-2 years in a leadership role (e.g., CTL, Assistant PM, CPM).
• Strong understanding of clinical trial operations, including protocol development, site management, monitoring, and reporting.
• Experience in managing complex projects, including cross-functional collaboration, resource allocation, and risk mitigation.

Skills:

• Excellent communication skills (written and verbal) to effectively interact with various stakeholders.
• Strong problem-solving and decision-making abilities, particularly when managing competing priorities.
• Ability to mentor and coach junior staff to ensure team success and growth.
• Proficient in clinical trial management systems (CTMS) and other industry-specific software.
• Strong attention to detail with an ability to follow through on commitments and ensure high-quality deliverables.

Preferred Qualifications:

• Previous experience managing large or multi-service clinical trials.
• Familiarity with managing investigator site contracts and budgets.
• Experience in training and mentoring junior project managers and clinical staff.

What We Offer:

• Competitive salary and benefits package.
• Opportunities for professional development and career growth.
• A dynamic and collaborative work environment.