Senior Clinical Project Manager - Cell & Gene Therapy

Remote

Responsibilities

They also compile and drive documentation for the project, ensuring the accuracy and quality of regulatory data.
Lead core project team(s) and facilitate team's ability to lead extended project team(s), ensuring effective cross-functional teamwork among project team members including both internal and external stakeholders.
Initiate and implement appropriate actions to proactively manage the change control process both internally and externally.
Ensure that all staff allocated to assigned project(s) adheres to professional standards and SOPs, providing performance feedback to team member’s respective supervisors.
Define and manage project resource needs and establish succession plans for key resources.
Perform other duties as assigned by management.

The Senior Project Manager is expected to have a working knowledge of drug development and clinical trial execution.
Qualifications (Minimum Required): University/college degree (life science preferred) or certification in a related allied health profession (i.e., nursing, medical or laboratory technology) from an appropriately accredited institution.
Fortrea may consider relevant and equivalent
experience in lieu of educational requirements.
Experience (Minimum Required): Minimum of seven (7) years of relevant clinical research
experience in a pharmaceutical company/CRO, including at least two (2) years of full project management responsibility. On the Job
Experience: Working knowledge of ICH Guidelines and GCP including international regulatory
requirements for the conduct of clinical development programs. Advanced computer skills (e.g., Microsoft Word, Excel, Project, Access, and Power Point).
Experience managing projects in a matrix and virtual environment.
Demonstrated ability to lead by example and to encourage team members to seek solutions independently.
Demonstrated ability to handle multiple competing priorities and to utilize resources effectively.
Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system.
Good knowledge of project management processes.