Clinical Start-Up & Trial Lead

Fortrea; São Paulo; Presencial; BRL 160.000 - 200.000; Tempo integral

Resumo da oferta

A leading clinical research organization in Brazil is seeking a Clinical Start-Up & Trial Lead to oversee clinical trial start-up activities and manage study operations. The ideal candidate will have 6 years of experience in clinical research, strong project leadership skills, and familiarity with EDC systems. This role involves collaboration with various teams to ensure the success of clinical studies and will require some travel.

Qualificações

• 6 years of clinical research experience with site start-up and project management.
• Prior experience in a CRO, biotech, or pharma environment.
• Strong knowledge of ICH GCP regulatory requirements.

Responsabilidades

• Lead country/site feasibility and activation strategy.
• Oversee development and negotiation of site contracts.
• Provide end-to-end operational oversight for assigned studies.
• Monitor overall study progress and implement mitigation plans.

Conhecimentos

Project leadership

Stakeholder engagement

Communication skills

Attention to detail

Problem-solving

Formação académica

Bachelor's degree in life sciences or a related field

Advanced degree

Ferramentas

Veeva Vault

Medidata

Descrição da oferta de emprego

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

• Bachelors 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 this dual-role position youll 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 .

Key Skills

Administrative Skills,Facilities Management,Biotechnology,Creative Production,Design And Estimation,Architecture

Employment Type: Full-Time

Experience: years

Vacancy: 1