Job Overview:Global Clinical Trial Project Manager, Remote - Home-Based
Must have experience managing Clinical Trials in Oncology from a global perspective.
Labcorp Drug Development gives you the best two-for-one opportunity for career growth. Who doesn’t want twice the perks? Working 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 located on the globe, we have an FSP opportunity for you.
Typically, under the direction of a Senior Project Manager/Project Director, the Project Manager II oversees and manages domestic, regional and/or projects. Responsibilities typically include 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 Project Manager is expected to have a working knowledge of drug development and clinical trial execution. The Project Manager also compiles and drives documentation for the project, ensuring the accuracy and quality of regulatory data.
Operational delivery
Responsible for project delivery with regards to agreed time, scope, cost and quality- Serve as key client contact for assigned project responsibilities, establishing working relationships with client project teams which result in client satisfaction, operational excellence and thereby increase potential for repeat business
- For areas of project responsibility, 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 Senior Project Manager and/or Project Director
- Serve as escalation point for project issues, within area of project responsibility, to internal and external stakeholders, as appropriate
- Proactively identify and resolve conflicts as needed
- Understand the project delivery strategy, costing assumptions and resulting budget for assigned project(s)
- Monitor project scope, schedule and costs to ensure 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
- Proactively lead both quality control and risk assurance activities to ensure project deliverables are met according to regulatory, Covance and client requirements
- 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
Education/Qualifications:- BA/BS or equivalent degree in a relevant discipline.
- Preferred:
- Masters or other advanced degree.
- PMP certification.
- Minimum of 4 years of relevant clinical research experience in a pharmaceutical company/CRO
- Experience in all phases of study execution
- Demonstrated leadership of a global clinical trial and management of CROs
- Experience with electronic quality, compliance and CTMS systems
- Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
- Broad knowledge of drug development process and client needs
Experience:
Working knowledge of project management processes- Experience managing projects in a virtual environment
- Demonstrated ability to handle multiple competing priorities and to utilize resources effectively
- Financial awareness and ability to actively utilize financial tracking systems
- 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 independently.
- Excellent communication, planning and organizational skills
- Ability to work independently
- Ability to negotiate and liaise with clients in a professional manner
- Ability to present to staff at all levels
- Knowledge and understanding of Microsoft office
- Travel is estimated around 25%