Job Overview:
Clinical Team Leads (CTL) own the clinical delivery of clinical research trials. CTLs function as the Clinical Project Manager (CPM) within the core project team. CTLs partner with the Project Manager other functional leads to ensure successful delivery of the clinical aspects of a trial within contractual budgetary requirements. The CTL oversees the clinical site management aspects of the trial. The CTL represents clinical delivery with the given customer.
Summary of Responsibilities:
Successful Clinical Team Leads will:
1. Take accountability fproactively driving clinical project performance toward contracted deliverables while meeting customer needs maintaining operational excellence
2. Drive communication collaboration with the client project team across a matrixed, multicultural, environment. Lead the development of the clinical project strategy ensures prioritization with the clinical project team key stakeholders in the creation of clear, data driven strategies proactive management of project scope, timelines, quality budget. In collaboration with relevant departments, prepare deliver presentations fnew business as required.
3. Manage the operational aspects of projects to support subject recruitment retention, clinical venddelivery oversee the monitoring visit strategy.
4. Identify clinical project, financial quality risks leveraging end to end risk management practices quality by design principles. Appropriately utilize data sources, dashboards risk management strategies to drive innovation proactive problem solving with the project client teams. Adhere to project governance issue escalation pathways, ensuring that clinical project plans are in place to address identified risk while adhering to professional standards, SOPs, client regulatory requirements
5. Partner with project team members key stakeholders to oversee manage clinical project budgets, resources scope. Ensure adherence to established budget financial milestones. Accountable faccurately forecasting clinical project revenue managing project costs in adherence to the budget. Leading the timely management of changes to scope the changeder process. Ensures project team awareness tracking of KPIs fany client specific metrics.
6. Provide inspiring leadership play a key role in the creation of high performing clinical project teams. Facilitating communication teamwork while driving delivery, ensuring that clinical team members understcontracted scope, timelines budget. Ensures that clinical resource projections are accurate visible to resourcing teams, proactively escalating resource constraints challenges. Develops mentors team members in multiple areas of expertise provide feedback as needed to respective line managers
7. As required by the project roles participate oversee the regulatory/ethics committee submissions, tracking, documentation.
8. Support new business with active participation in Bid Defense preparation meetings, as required.
9. all other duties as needed assigned
Qualifications(Minimum Required):
1. University/college degree (life science preferred) certification in a related allied health profession (i.e. nursing, medical laboratory technology) from an appropriately accredited institution
2. Fortrea may consider relevant equivalent experience in lieu of educational requirements.
3. Fluent in English, both written verbal.
Experience (Minimum Required):
1. 2+ years clinical research/monitoring experience an equivalent combination of education experience to successfully perform key responsibilities of the job.
On the Job Experience:
2. Working knowledge of ICH Guidelines GCP including international regulatory requirements fthe conduct of clinical development programs.
3. Advanced computer skills (e.g., Microsoft Word, Excel, Project, Access Power Point)
4. Experience managing projects in a matrix virtual environment
5. Excellent communication, planningganizational skills
6. Demonstrated ability to lead by example to encourage team members to seek solutions independently Demonstrated ability to handle multiple competing priorities to utilize resources effectively
7. Demonstrated ability to inspire effective teamwork motivate staff within a matrix system
8. Financial awareness ability to actively effectively utilize financial tracking systems
9. Ability to work independently mentjuniproject team members
10. Ability to negotiate liaise with clients in a professional manner
11. Ability to present to staff at all levels
Preferred Qualifications Include:
1. Master other advanced degree
2. PMP certification
3. 2+ years CRA experience, on-site in-house.
4. In lieu of the above minimum requirement, candidates with three more years of relevance clinical research experience in pharmaceutical, CRO health care setting will be considered
Physical Demands / Work Environment:
1. Standard Office Environment remote based work required
2. Weekend off-hour work as required
3. Travel Requirements: up to 30% (Global – primary domestic international)
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