Clinical Project Manager II, Phase I

Posted 2 Days Ago
Be an Early Applicant
Hiring Remotely in United States
Remote
125K-135K Annually
Senior level
Biotech
The Role
Lead end-to-end operational strategy and delivery for Phase I clinical trials. Manage scope, timelines, risk, budget, and client relationships across global, matrixed teams. Mentor staff, oversee financials and KPIs, ensure regulatory and quality compliance (ICH/GCP), and drive issue escalation and resource planning.
Summary Generated by Built In
Our Phase I team is seeking an Clinical Project Manager II to join our growing team. This role requires 2+ years of global project management experience, with preferred experience in phase I. Candidates must be based in the United States.

Job Overview:

Project Managers own the operational strategy, determining the most cost effective and efficient means to successfully run and complete projects on time, while maintaining quality, remaining within budget, while meeting the customer’s needs and adhering to the contract. Project Managers will work to develop and lead high performing teams by collaborating with key stakeholders to manage all aspects of the end-to-end lifecycle of the project including scope, timelines, risk, and budget. A successful Project Manager will bring innovation and future focused approaches to clinical trials with a focus on patient centricity and consistent solutions-oriented delivery.

Summary of Responsibilities:

  • Take accountability for proactively driving project performance toward contracted deliverables while meeting customer needs and maintaining operational excellence.

  • Take ownership of the customer relationship while drawing on the Company’s pool of experts.

  • Drive communication and collaboration with the client and project team across a matrixed, multi-cultural, environment. Lead the development of the project strategy and ensure prioritization with the project team and key stakeholders in the creation of clear, data driven strategies and proactive management of project scope, timelines, quality, and budget. In collaboration with relevant departments, prepare and deliver presentations for new business as required.

  • Lead the identification of project, financial and quality risk leveraging end to end risk management practices and quality by design principles. Appropriately utilize data sources, dashboards, and risk management strategies to drive innovation and proactive problem solving with the project and client teams. Lead the adherence to project governance and issue escalation pathways, ensuring that project plans are in place to address identified risk while adhering to professional standards, SOPs, client, and regulatory requirements.

  • Partner with project team members and key stakeholders to oversee and manage project budgets, resources, and scope. Ensure adherence to established budget and financial milestones. Accountable for accurately forecasting project revenue and managing project costs in adherence to the budget. Leading the timely management of changes to scope and the change order process. Ensures project team awareness and tracking of KPIs for any client specific metrics.

  • Provide inspiring leadership and play a key role in the creation of high performing project teams. Facilitating communication and teamwork while driving delivery, ensuring that team members understand contracted scope, timelines, and budget. Ensures that resource projections are accurate and visible to resourcing teams, proactively escalating resource constraints and challenges. Develops and mentors team members in multiple areas of expertise and provides feedback as needed to respective line managers.

  • 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 five (5) years of relevant clinical research experience in a pharmaceutical company/CRO.

  • 2+ years of Clinical Project Management experience within a CRO or pharma company

  • Experience working on Phase I studies

  • In lieu of the above requirement, candidates with (a) six (6) years supervisory experience in a heath care setting and (b) five (5) years clinical research experience including one (1) years of project management experience (international clinical trial management experience preferred) in the pharmaceutical or CRO industries will be considered

  • 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.

  • 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

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): $ 125 - 135k

#LI - Remote

Applications will be accepted on an ongoing basis

Physical Demands/Work Environment:

  • Standard Office Environment or remote based work required.

  • Weekend and off-hour work as required.

Travel Requirements:

  • Local, Domestic, Regional, Global

Identify the expected travel requirements of the position on an annual basis:

  • % of time: up to 30%

  • % of the above that requires overnight stay: up to 30%

  • Travel is primarily to where: domestic and international travel

Learn more about our EEO & Accommodations request here.

Skills Required

  • Based in the United States
  • University/college degree (life science preferred) or allied health certification
  • Minimum five (5) years relevant clinical research experience in a pharmaceutical company or CRO
  • 2+ years of Clinical Project Management experience within a CRO or pharma company
  • Experience working on Phase I studies
  • Working knowledge of ICH Guidelines and GCP including international regulatory requirements
  • Advanced computer skills (Microsoft Word, Excel, Project, Access, PowerPoint)
  • Experience managing projects in a matrix and virtual environment
  • Excellent communication, planning, and organizational skills
  • Demonstrated ability to lead, mentor, and inspire teams within a matrix system
  • Ability to handle multiple competing priorities and utilize resources effectively
  • Financial awareness and ability to actively utilize financial tracking systems
  • Ability to negotiate and liaise with clients professionally and present to all staff levels
  • Master's or other advanced degree
  • PMP certification
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The Company
HQ: Durham, NC
10,811 Employees

What We Do

Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology-enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com.

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