Senior Clinical Project Manager, IQVIA Biotech

IQVIA - Northfield, NJ

Full-time - Senior

Northfield, NJ

Professional, Scientific, and Technical Services

About the position

The Senior Clinical Project Manager at IQVIA Biotech is responsible for the successful planning, implementation, and execution of clinical studies. This role involves managing project teams, ensuring compliance with Good Clinical Practices (GCP), and maintaining clear communication with clients. The position also supports the development of functional training and process improvement within the department.

Responsibilities

• Manage full scope regional and global clinical projects.
• Lead project teams and ensure effective communication among team members.
• Build and maintain positive client relationships.
• Negotiate with clients to maintain operational processes and project scope.
• Review project study trends and respond proactively to challenges.
• Develop early warning systems for potential project obstacles.
• Identify and document training requirements in LMS systems.
• Manage change on all assigned projects and ensure compliance with SOPs and WP.
• Ensure project timelines are met according to contract specifications.
• Document processes that need updating and communicate with management.
• Maintain current project reporting and client relationships.
• Assist in developing and updating internal processes and quality assurance forms.
• Provide project support to Managers as assigned.
• Oversee delegation of support staff activities as necessary.
• Assist in developing capability and proposal defense presentations for clients.
• Support Contracts and Proposals with project contract execution and documentation.
• Represent senior management in contract negotiations as appropriate.
• Participate in performance appraisal programs for team members.
• Maintain knowledge of FDA regulations, GCP, and ICH Guidelines for clinical research.

Requirements

• Thorough knowledge of the clinical research process from Phase I through regulatory submission.
• Strong verbal and written communication skills.
• Excellent organizational and interpersonal skills.
• Ability to manage multiple priorities in complex clinical trials.
• Independent reasoning for assessing and recommending solutions in clinical settings.
• Ability to set baseline targets, track trends, and implement mitigation plans.
• Understanding of basic data processing functions, including electronic data capture.
• Demonstrated problem-solving and financial negotiation skills.
• Working knowledge of current ICH GCP guidelines.