Clinical Team Lead

hace 2 semanas


Tlahuac, México Fortrea A tiempo completo

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Clinical Trial Lead

Remote

In this role, 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.

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Additionally, you will be responsible for:

- 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

**Education**:
University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate.

**Experience**:

- Zero to four (0-4) years' experience as a CTL, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job.
- Minimum four plus (4+) years CRA experience, on-site or in-house.

Or

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit


Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other med



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