Senior Clinical Project Manager, Phase I

Fortrea

$140K — $150K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • 4-5+ years of global project management experience, particularly in Phase I clinical trials
  • University/college degree in life sciences or allied health, or equivalent experience
  • In-depth understanding of ICH Guidelines and GCP with international regulatory knowledge
  • Experience in managing projects within a matrix and virtual environment
  • Strong communication, planning, and organizational skills

Responsibilities

  • Oversee and manage domestic and global clinical projects under the guidance of a Project Director
  • Ensure project deliverables align with time, scope, cost, and quality requirements
  • Act as the primary client contact, fostering client relationships for operational excellence
  • Lead core project teams and facilitate cross-functional teamwork
  • Proactively manage project scope and implement change control as needed
  • Conduct quality control and risk management activities to meet regulatory standards
  • Mentor junior project members and maintain project documentation for regulatory compliance

Benefits

  • Comprehensive medical, dental, and vision insurance
  • 401(K) retirement plan
  • Paid time off (PTO) with a flexible plan
  • Employee recognition awards
  • Opportunities to join multiple employee resource groups (ERGs)
Full Job Description
Our Phase I team is seeking a Sr. Clinical Project Manager to join our growing team. This role requires 4-5+ years of global project management experience, with mandatory experience in phase I. Candidates must be based in the United States or Canada.

Job Overview:

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.

Summary of Responsibilities:
  • Operational delivery.
  • Accountable for project delivery with regards to agreed time, scope, cost, and quality.
  • TEAM COMMUNICATION: 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. Depending on size and scope of project(s), this job duty may be performed in collaboration with a Project Director.
  • Serve as escalation point for project issues to internal and external stakeholders, as appropriate.
  • TEAM COMMUNICATION: Proactively identify and resolve conflicts as needed.
  • COST: Understand the project delivery strategy, costing assumptions and resulting budget for assigned project(s).
  • SCOPE: 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.
  • RISK: Proactively lead both quality control and risk assurance activities to ensure project deliverables are met according to regulatory, Fortrea and client requirements.
  • QUALITY: Create and manage variance to required project plans. Per SOPs, 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'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.
  • Business Development.
  • In collaboration with relevant departments, prepare and deliver presentations for new business as required.
  • Perform other duties as assigned by management.
  • Line Management and Talent Development.
  • 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.


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.
  • Phase I 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.
  • 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.


Preferred Qualifications Include:
  • Master's or other advanced degree
  • PMP certification
  • Biotech experience
  • Fluent in Chinese/Mandarin


What do you get?

Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including but not limited to:
  • Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers)
  • 401(K)
  • Paid time off (PTO) - Flex Plan
  • Employee recognition awards
  • Multiple ERG's (employee resource groups)
  • Target Pay Range (based on title): $140-150k


#LI - Remote

Applications will be accepted on an ongoing basis.

Work Environment:
  • Work is performed in an office environment with exposure to electrical office equipment.
  • 30% travel


Physical Requirements:
  • Ability to sit for extended periods and operate a vehicle safely.
  • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
  • Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
  • Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
  • Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
  • Regular and consistent attendance.
  • Varied hours may be required.


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