As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Senior Project Manager, CPS

Remote within the United States

The Senior Project Manager, CPS will be responsible for overseeing and managing domestic, regional and/or international clinical trials conducted at Fortrea Clinical research sites, external sites, and data services projects. Projects generally include full service including multiple moderately complex trials managing multiple vendors and external sites for trials of high financial value and may consist of serving in a program oversight role. Primary clients contact and responsible for the facilitation of communication, managing client expectations, and building business relationships. Responsibilities typically include managing scope of project and project components, budgets, timelines, and quality guidelines thereby ensuring that expectations are met while identifying, and mitigating risks. Responsible for managing the project team and mentoring others in a matrix environment. May also contribute to strategic relationships by monitoring and reporting Key Performance Indicators (KPI), and may initiate process improvements to address variance, and may serve as a committee member on a governance structure. Using thorough knowledge of clinical development, may design delivery strategy for large scale bid defense and perform other business development activities.

Summary of job Responsibilities:

• May act as a single point of contract for the client Project Manager on a program of studies,
• while adhering to professional, SOP, regulatory and ICH/GCP standards.
• Assesses resource needs for project or program delivery based on scope of services to be provided.
• Manages and communicates scope of the program or project according to proposal, budget, timeline throughout the life cycle of the project.
• Works with project team on identification of work scope changes against the program or project timelines.
• Creates and/or review required project plans. Implement and monitor progress against project.
• Organizes, chairs, and ensures accurate documentation in meeting minutes for program or project meetings with client and team, as applicable.
• Completes, or delegates with oversight, the Project Log (Action/Decision/Issues) items to ensure appropriate project team member delegation and resolution.
• Renegotiates timelines and budgets with client and project team, as necessary.
• Has extensive understanding of complex clinical, external site management, biometrics, and critical path activities.
• Improves project and program margins based on project financial expertise and minimizes write offs.
• Proactively engages in development of project and or department quality assurance and risk mitigation activities that are cost effective and obtain agreement with client and key stakeholders.
• Collaborates with finance when project milestones or completion of contracted units of activity have been met to approve monthly invoicing, and performs client follow up as appropriate
• Serves as the escalation point for project uses and resolves conflicts, as necessary.
• Accountable for TMFs including TMF Index & Plan, audit readiness and delivery of the TMF per agreed upon timelines, when contracted by client.
• May oversee timely uploading of documents by the project team into the TMF for client held systems.
• Accountable for directing the CTMS build, working with project team to ensure loading of information for site activation and timely entry of key milestones for site payment.
• Accountable for developing Project Specific Training and ensuring project team members have read, reviewed, and documented project related documents and plans.
• Drives issue resolution at the project and program level and ensures proper escalation of potential CQI per Fortrea SOPs.
• Contributes to audit responses from agencies and clients, as appropriate.
• Ensures lessons learned are implemented across projects currently being managed and across the department as applicable.
• Attend Triage meeting as required.
• Increase potential for repeat business by establishing a strong working relationship with client project team striving for client satisfaction and operational excellence.
• Contributes to proposal strategy, development, and leads bid defense strategy for assigned business development opportunities.
• May own a relationship with key strategic clients(s) with development and implementation of partnership plans, processes, tool, and templates.
• Leads implementation of process excellence initiatives on projects and across departments that enhance the efficiency, and the quality of the work performed on a program or project.
• Develop strategic client metrics and track project metrics across program as needed.
• Monitor and report KPI for strategic relationships, actively managing to ensure they are within the scope of the contract and initiate process improvements to address variance.
• May serve as a committee member in a governance structure for strategic clients.
• Assists training and development of more junior and project team staff.
• Develops or is a SME contributor to department training material.
• May perform supervisory duties including, but not limited to, interviewing, hiring, training, developing, performance evaluation, intervention, discipline, and discharge for Project Managers
• Responsible for the oversight of site start up activities.
• Oversees the coordination of the study activation components of the project from an oversight level including Feasibility, Site selection, Activation, Site Contracting, Regulatory Submission, Greenlight.
• Assists in the design and maintenance of tools/processes relevant to feasibility assessments and patient recruitment campaigns.
• Supervision of Investigator package review and approval prior to drug shipment.
• Supervision of study set-up with the clients regarding pre-study documentation for Investigator packages.
• Supervision of Site Budget and Statements of Agreement (SOA) documents that leads to an executed site contract.
• Supervision of Document Review, including Informed Consent Forms, Advertisements, labels, and protocols.
• All other duties as needed or assigned

Minimum Required Qualifications

• University/college degree or certification in a related allied health profession (i.e., nursing, medical or laboratory technology) from an appropriately accredited institution.
• In lieu of the above requirement, candidates with a 2-year associate degree and an additional 5 or more years of relevant clinical research experience in pharmaceutical, CRO industries or experience in a health care setting will be considered.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Minimum Required Experience:

• Minimum of 7 years’ relevant clinical research experience in a pharmaceutical company/CRO including demonstrated skills and competency in project management tasks.
• Patient clinical trial experience, ideally Phase Ib experience
• Experience in managing projects in a virtual environment.
• Demonstrated ability to handle multiple competing priorities and to utilize resources effectively.
• Financial awareness and ability to track project progress against financial milestones.
• Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system.
• Demonstrated ability to lead by example and to encourage team members to seek solutions.
• Excellent communication, planning and organizational skills.
• Ability to negotiate and liaise with clients in a professional manner.
• Ability to present to staff at all levels.
• Good computer skills with good working knowledge of a range of software packages.
• Detailed knowledge of project management processes.
• In lieu of the above experience requirement, a combination of other experiences including, but not limited to preclinical research, clinical biometrics, clinical study management, clinical monitoring, and clinical project management may be considered

Preferred Experience:

• Master’s or other advanced degree.
• Working knowledge of Fortrea with cross functional department expertise.
• Basic knowledge of Fortrea sales and business development strategies and procedures.
• Working knowledge of Fortrea SOPs.
• Certified in Clinical Research – PMP, SOCRA/ACRP Certification.
•  PMP Certification.
• Six Sigma trained

Travel:  Up to 30% travel required both domestic and international including overnight stays.

Pay Range: 135,000k – 165,000k USD

Benefits: All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable.  For more detailed information, please.    Application Deadline: September 25th, 2024

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.

Fortrea is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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