Clinical Start-up

1 semana atrás

São Paulo, Brasil Fortrea Tempo inteiro

**Position Summary**

The Clinical Start-Up & Trial Lead (Start-Up + CTL) is responsible for the strategic planning, coordination, and oversight of clinical trial start-up activities as well as the ongoing execution of clinical studies. This hybrid role ensures operational excellence from site initiation through to study close-out, serving as the primary operational point of contact for internal teams, vendors, and clinical sites.

**Key Responsibilities**

**Start-Up Responsibilities**
- Lead country/site feasibility, site selection, and activation strategy in collaboration with project teams.
- Oversee development and negotiation of site contracts, budgets, and regulatory/ethics submissions.
- Track and report on start-up timelines, metrics, and bottlenecks; drive resolution.
- Collaborate with Regulatory, Legal, and Contracts to ensure timely delivery of activation packages.
- Ensure readiness for site initiation visits (SIVs) and coordinate site training.

**Clinical Trial Lead Responsibilities**
- Provide end-to-end operational oversight for the assigned study(ies), including CRO/vendor and site performance.
- Lead cross-functional study team meetings and act as key escalation point for site-level issues.
- Monitor overall study progress, timelines, and quality metrics; implement mitigation plans as needed.
- Drive proactive risk identification and resolution, aligning with RBQM principles.
- Ensure inspection-readiness through quality oversight of TMF, monitoring reports, and issue management.
- Partner with data management, medical, and safety teams to ensure clean, timely data delivery.

**Qualifications**

**Education & Experience**
- Bachelor’s degree in life sciences or a related field; advanced degree preferred.
- 6+ years of clinical research experience, including significant site start-up and CTL/project management responsibilities.
- Prior experience in a CRO, biotech, or pharma environment required.
- Strong knowledge of ICH GCP, regulatory requirements, and clinical trial lifecycle.

**Skills & Competencies**
- Proven ability to manage multiple timelines and priorities with attention to detail.
- Strong project leadership and stakeholder engagement skills.
- Familiarity with EDC, CTMS, eTMF, and site start-up platforms (e.g., Veeva Vault, Medidata).
- Excellent communication, negotiation, and team-building skills.
- Solution-oriented mindset and comfort with ambiguity in fast-paced environments.

**Travel Requirements**
- Up to 20% domestic and/or international travel, as needed.

**Why Join Us?**

We offer a dynamic environment where innovation, accountability, and integrity are valued. In this dual-role position, you'll have an opportunity to shape trial success from the very beginning and carry that leadership throughout the study lifecycle.

Learn more about our EEO & Accommodations request here.

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