Senior Project Manager

Posted 8 Days Ago
Be an Early Applicant
Tokyo, JPN
In-Office
Senior level
Biotech
The Role
Lead and deliver clinical development projects by managing scope, schedule, cost, quality, risk, and stakeholders; serve as client contact; lead cross-functional teams; ensure regulatory data accuracy; mentor staff; support business development, resource planning, and KPIs.
Summary Generated by Built In

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, establishingworking 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 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.
    • 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.
    • 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.
    • 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

    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

    • University/college degree (life science preferred) or certification in allied health (nursing, medical or laboratory technology)
    • Minimum of seven (7) years 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 Good Clinical Practice (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 teams, mentor junior staff, and work independently
    • Financial awareness and ability to utilize financial tracking systems
    • Good knowledge of project management processes, change control, and risk/quality assurance
    • Ability to negotiate, liaise with clients, and present to staff at all 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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