Principal Clinical Team Lead - Homebased
The Principal Clinical Team Lead (PCTL) is responsible and accountable for the driving the delivery of the clinical deliverable acting as the Clinical Project Manager role within the Core Team, as well as the portfolio team. The P CTL is expected to provide study and/or portfolio oversight of the clinical operations from a quality, timeline, budget and scope perspective. If needed for studies where combining the PM/CTL roles are feasible, the P CTL is capable of concurrently managing both Clinical and Project Delivery roles to ensure successful execution of the trial. The P CTL must have the ability to lead multiple functions as a Project Lead as well as leading multiple levels of CTLs on a portfolio of large global trials.
Essential Job Duties:
- Full oversight of a client portfolio for streamlined, efficient, high quality, consistent study delivery.
- Overall ownership of client-specific templates, SOPs, and guidance.
- Liaison for escalations within the clinical team which have an effect on deliverables.
- Responsible for clinical project delivery at the portfolio and/or project level with regards to agreed time, scope, cost and quality.
- Accountable for leading clinical deliverables across the all functions for the assigned portfolio and/or studies.
- Support/Lead Clinical project team ensuring effective cross-functional teamwork among project team members including both internal and external stakeholders.
- Serve as escalation point for clinical project issues, within area of project responsibility, to internal and external stakeholders, as appropriate.
- Serve as a 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.
- Proactively identify and resolve conflicts across the entire portfolio as needed.
- Understand the clinical project delivery strategy, costing assumptions and resulting budget for assigned project(s).
- Monitor clinical project scope, schedule and costs to ensure all remain on track with the contract and with financial performance targets. Initiate appropriate actions to proactively manage the change control process working in.
- Proactively lead both quality control and risk assurance activities to ensure clinical project deliverables are met according to regulatory, Labcorp and client requirements.
- Ensure successful creation and implementation of required clinical project plans. Monitor progress and manage variance to required clinical project plans and revise as necessary per SOPs. Ensure that all staff allocated to assigned project(s) adheres to professional standards and SOPs, providing performance feedback to team member's respective supervisors.
- Track and maintain key clinical project performance indicators for specified client and internal metrics. Drive successful clinical team delivery on these KPIs/metrics.
- Define and manage clinical project resource needs and establish succession plans for key resources.
- May act in a blended role between Project Management, Clinical Project Delivery and/or Start-up Project Management
- Perform other duties as required by the Department or Project Team
- In collaboration with relevant departments, prepare and deliver presentations for new business as required.
- Trains & mentors Sr.CTLs, CTLs, CRAs and IHCRAs in multiple areas of expertise.
- Accountable for project delivery with regards to agreed time, scope, cost and quality
- Serve as a 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
- Proactively identify and resolve conflicts as needed
- Play an active role in understanding Root Cause for Quality Issues and help develop CAPA to be applied over entire portfolio.
- Take an active role in any major escalations to mitigate risk over the entire portfolio.
- Understand the project delivery strategy, costing assumptions and resulting budget for assigned project(s)
- 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
- 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
- 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
- Partner with Delivery Directors to ensure an understanding of Sponsor pipelines, Book of Business Growth, in order to partner with key stakeholders in regards to resource planning and business expansion.
- Perform other duties as assigned by management
- Trains & mentors all functions supporting Clinical Delivery 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 clinical project management competencies for assigned staff in order to create developmental plans that will increase competencies and close performance gaps
- Provides technical support to assigned project leaders, including training, development and performance review of assigned staff
- Will support revising and developing processes for Global Clinical Project Delivery (GCPD)
- Expected to be an internal key contact for process questions impacting (GCPD)
- University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)
- Fluent in English
- Relevant Masters or other advanced degree
- PMP Certification
In lieu of the above requirement, candidates with seven (7) or more years of relevant clinical research experience in pharmaceutical or CRO industries may be considered
Minimum Required Experience:
- Six (6) years relevant clinical research experience in a pharmaceutical company/CRO, including at least three (3 ) years of CTL or equivalent combination of experience to successfully perform the responsibilities of the job.
- 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
- 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 internal and external staff at all levels
- Prior portfolio oversight
- Two (2) years of full project leadership or management responsibility
- PMP Certification
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