The Clinical Team Lead (CTL) is responsible and accountable for the driving the delivery of the clinical deliverables, acting within the Clinical Project Management (CPM) role within the Core Team or supporting the CPM, as assigned. The CTL is responsible for working cross functionally, within a matrix environment, to ensure successful execution of the trial including oversight of the clinical operations from a quality, timeline, budget and scope perspective.
- Responsible for clinical project delivery with regards to agreed time, scope, cost and quality.
- Key clinical deliverables include but are not limited to:
- Patient recruitment and retention
- Ensuring the clinical project team is resourced effectively
- Agile management of the Monitoring Visit Strategy
- Management of SDV burden
- Clinical vendor delivery
- Management of clinical deliverables related to protocol endpoints
- Responsible for leading clinical deliverables across the following functions (this list is not exhaustive and may change dependent on the study):
- Clinical Team Leads
- Clinical Research Associates (CRA)
- Inhouse CRAs
- GSDM Clinical Functions
- TMF Delivery Center
- Clinical and Ancillary Supplies Services
- Regulatory Affairs (post initial approval)
- Local Site Start-Up Operations (post initial approval)
- Site ID
- 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 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. Depending on size and scope of project(s), this job duty may be performed in collaboration with a Senior CTL and/or CPDM.
- Proactively identify and resolve conflicts 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.
- Proactively lead both quality control and risk assurance activities to ensure clinical project deliverables are met according to regulatory, Covance 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.
- 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 CRAs and IHCRAs in multiple areas of expertise.
- 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.
- Masters or other advanced degree.
- PMP certification.
Minimum 0-4 year's experience as a CTL, Project Manager or an equivalent combination of education and experience to successfully perform key responsibilities of the job.
2+ years CRA experience, on-site or in-house.
Global clinical project management experience.
In lieu of the above minimum requirement, candidates with three or more years of relevance clinical research experience in pharmaceutical, CRO or health care setting will be considered.
- 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
- Basic 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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