Clinical Start-up

hace 5 días

Ciudad de México Fortrea A tiempo completo

**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.

  • Clinical Start-Up

    hace 4 días

    Ciudad de México, Ciudad de México Fortrea A tiempo completo $120,000 - $180,000 al año

    Position SummaryThe 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...

  • Start-Up Manager

    hace 1 semana

    Ciudad de México, Ciudad de México Novo Nordisk, Inc. A tiempo completo $2,000,000 - $2,500,000 al año

    Start-Up ManagerCategory: Clinical DevelopmentLocation:Ciudad de México, Ciudad de México, MXClincal Development CenterMéxicoAre you passionate about clinical trial management and regulatory excellence? Do you thrive in an unordinary and dynamic environment where collaboration and innovation drive success? If you have a strong background in clinical...

  • Start-Up Manager

    hace 1 semana

    Ciudad de México, Ciudad de México Novo Nordisk A tiempo completo $250,000 - $450,000 al año

    Clincal Development CenterMéxicoAre you passionate about clinical trial management and regulatory excellence? Do you thrive in an unordinary and dynamic environment where collaboration and innovation drive success? If you have a strong background in clinical development and are ready to lead the way in ensuring seamless trial start-up activities, we want to...

  • Start-Up Manager

    hace 2 semanas

    Ciudad de México, Ciudad de México Novo Nordisk A tiempo completo $1,200,000 - $2,400,000 al año

    Clincal Development CenterMéxicoAre you passionate about clinical trial management and regulatory excellence? Do you thrive in an unordinary and dynamic environment where collaboration and innovation drive success? If you have a strong background in clinical development and are ready to lead the way in ensuring seamless trial start-up activities, we want to...

  • Start-up & Regulatory Specialist II

    hace 2 días

    Ciudad de México, Ciudad de México Fortrea A tiempo completo USD104,000 - USD130,878 al año

    Shape the Future of Global Clinical TrialsJoin our dynamic team and lead the crucial start-up phase of impactful clinical trials, with opportunities for international exposure. You'll ensure projects are delivered on time, within budget, and to the highest quality standards, directly contributing to life-changing medical advancements.Your ImpactDrive the...

  • Study Start Up Associate Ii

    hace 5 días

    Ciudad de México ICON Plc A tiempo completo

    Study Start Up Associate II - Mexico - Homebased ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Study Start Up...

  • Study Start-up Associate Senior

    hace 2 semanas

    Ciudad de México, Ciudad de México Emmes A tiempo completo USD60,000 - USD120,000 al año

    Study Start-up Associate SeniorLATAM RemoteEmmes Group: Building a better future for us all.Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US...

  • Study Start Up Associate I

    hace 3 días

    Ciudad de México ICON Plc A tiempo completo

    Study Start Up Associate I - Hybrid - Mexico CityICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical developmentWe are currently seeking a Study Start Up Associate...

  • Study Start Up Associate I

    hace 5 días

    Ciudad de México ICON Plc A tiempo completo

    Prefer Clinical Regulatory Exp. ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Study Start Up Associate I to join our...

  • Study Start-up Project Manager

    hace 2 semanas

    Ciudad de México Medpace, Inc. A tiempo completo

    Job Summary: Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based Study Start-Up Manager (Regulatory Submissions Manager) to support our growing Study Start-Up/Regulatory Submissions team at Medpace! This position plays a key role in the clinical trial management process at Medpace. If you want an...