FSP - Senior Project Manager, PM COE
Senior Global Clinical Trial Project Manager
Remote - Home-Based
Must have experience managing Clinical Trials in Cardiovasculr from a global perspective and have strong vendor management experience.
Labcorp Drug Development gives you the best two-for-one opportunity for career growth. Who doesn't want twice the perks ? W orking at one of the largest FSP CROs-and partnering with one sponsor with a dedicated therapeutic focus. You can have it all!
Dedicated to an FSP project , you will bring your specialized discipline to a core team working directly with one sponsor. Whether your specialization is in clinical monitoring, clinical project management, data management, biometrics or pharmacovigilance , we have an FSP opportunity to match your area of expertise.
You will enjoy the best of both worlds-all the benefits that come along with our Energizing Purpose, Exceptional People and Extraordinary Potential combined with working exclusively with one sponsor and this also comes with the benefit of bringing your strong therapeutic experience to allow your expertise to shine through.
Our FSP model is flexible and scalable. Our teams are collaborative and proactive - a great place for you to continue honing your therapeutic skills and growing and excelling in new and exciting research.
Our reach is global - extending to 60+ countries making us one of the largest FSP CROs. No matter where you are locat ed on the globe, we have an FSP opportunity for you.
In this role, the selected candidte will providestrategic and operational leadership of clinical research studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs/WPs.
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, Covance 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
In collaboration with relevant departments, prepare and deliver presentations for new business as required
Perform other duties as assigned by management
Line Management & Talent Development
Trains & 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
- 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
- COVID-19 vaccination required
- Master or other advanced degree
- PMP certification
Minimum of 6 years of relevant clinical research experience in a pharmaceutical company/CRO, including at least two (2) years of in direct multinational study management.
Ability to work on site if located within 50 miles of site.
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
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