Clinical Start-Up

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 operational point of contact for internal teams, vendors, and clinical sites.Key ResponsibilitiesStart-Up ResponsibilitiesLead 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 ResponsibilitiesProvide 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.QualificationsEducation & ExperienceBachelor'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 & CompetenciesProven 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 RequirementsUp 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.