Clinical Operations Specialist

2 semanas atrás

São Paulo, São Paulo, Brasil beBeeClinical Tempo inteiro R$90.000 - R$120.000
Clinical Start-Up Lead Role

We are seeking a seasoned Clinical Start-Up Lead to join our team and play a pivotal role in shaping trial success from inception to completion.

This dynamic position will involve overseeing the strategic planning, coordination, and execution of clinical trial start-up activities, ensuring operational excellence from site initiation through to study close-out. As the primary operational point of contact for internal teams, vendors, and clinical sites, you will be responsible for driving the timely delivery of activation packages, managing site contracts, budgets, and regulatory/ethics submissions, and tracking/reporting on start-up timelines, metrics, and bottlenecks.

Key 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 assigned studies, 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 and Skills:

  • 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.
  • 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.
  • Excellent communication, negotiation, and team-building skills.
  • Solution-oriented mindset and comfort with ambiguity in fast-paced environments.

Benefits and Requirements:

  • Up to 20% domestic and/or international travel, as needed.

About Us:

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

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