Senior Clinical Project Manager - Cell & Gene Therapy

Fortrea•Durham, CA

2d•Remote

About The Position

Our FSO team is seeking an Cell & Gene Therapy Sr. Clinical Project Manager to join our growing team. This role requires 4+ years of global project management experience, with mandatory experience in cell & Gen. Candidates must be based in the United States. At times working under the direction of a Project Director, the Senior Project Manager oversees and manages domestic, regional and/or global projects. Responsibilities typically include developing and managing project teams, communications, risk, scope, schedule, cost, quality, and stakeholders, effectively ensuring that variance from plan is proactively and effectively mitigated and client expectations are met. The Senior Project Manager is expected to have a working knowledge of drug development and clinical trial execution. They also compile and drive documentation for the project, ensuring the accuracy and quality of regulatory data. The Senior Project Manager may also have line management and / or business development responsibilities.

Requirements

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.
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.
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.
Excellent communication, planning, and organizational skills.
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.
Financial awareness and ability to actively utilize financial tracking systems.
Good knowledge of project management processes.
Ability to work independently and mentor junior project team members.
Ability to negotiate and liaise with clients in a professional manner.
Ability to present to staff at all levels.

Nice To Haves

Master’s or other advanced degree
PMP certification

Responsibilities

Accountable for project delivery with regards to agreed time, scope, cost, and quality.
Serve as key client contact for assigned projects, establishing working relationships with client project teams which result in client satisfaction, operational excellence and thereby increase potential for repeat business.
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.
Serve as escalation point for project issues to internal and external stakeholders, as appropriate.
Proactively identify and resolve conflicts as needed.
Deliver project(s) to scope, schedule, and costs, ensuring all remain on track with the contract and with financial performance targets.
Initiate and implement appropriate actions to proactively manage the change control process both internally and externally.
Proactively lead both quality control and risk assurance activities to ensure project deliverables are met according to regulatory, Fortrea and client requirements.
Create and manage variance to required project plans.
Implement and monitor progress against project plans and revise, as necessary.
Ensure that all staff allocated to assigned project(s) adheres to professional standards and SOPs, providing performance feedback to team member’s respective supervisors.
Aid in development and maintenance of key project performance indicators for client specified metrics, ensuring that the KPIs are within scope of the project contract.
Define and manage project resource needs and establish succession plans for key resources.
In collaboration with relevant departments, prepare and present presentations for new business as required.
Perform other duties as assigned by management.
Trains and mentors PM Academy PCs in multiple areas of expertise.
May be responsible for Line Management and Talent Development.
Ensures allocated resources are aligned with current and forecasted work in terms of capability, quantity, timing, and efficiency.
May be responsible for on-boarding, development, and retention of high performing talent; strengthening and deepening talent bench and succession.
Assesses project management competencies for assigned staff in order to create developmental plans that will increase competencies and close performance gaps.
Provides line management and technical support to assigned project leaders, including training, development, and performance review of assigned staff.
All other duties as needed or assigned.