Clinical Operations will support and / or lead the operational execution of Phase 3 clinical trials for small-molecule drug programs, ensuring studies are delivered on time, within budget, and in compliance with GCP, protocol, and regulatory requirements. Level of accountability for the following areas will vary by seniority :
Study Planning & Execution
- Support / Coordinate / Lead day-to-day operational activities for Phase 3 clinical trials
- Support / Manage study timelines, milestones, and deliverables
- Assist with / Own study start-up activities including site activation and readiness
- Support / Lead protocol execution and operational feasibility
CRO & Vendor Oversight
Coordinate / Manage CRO activities and deliverablesSupport / Lead vendor selection, onboarding, and oversight (CROs, central labs, IRT, imaging)Track / Manage CRO performance, metrics, and issue resolutionEscalate / Resolve operational risks and deviationsSite Management & Monitoring Oversight
Support / Coordinate / Lead site management activities through CRO or internal monitorsTrack / Ensure site activation, enrollment, and retention performanceSupport / Manage site issues, protocol deviations, and compliance concernsReview / Approve monitoring reports and follow-up actions (per level)Trial Documentation & Compliance
Prepare / Review / Approve essential documents (TMF, study plans, monitoring plans)Ensure / Support Trial Master File completeness and inspection readinessSupport / Lead GCP compliance activitiesSupport / Participate in audits and inspectionsCross-Functional Collaboration
Coordinate / Lead interactions with different internal stakeholders e.g. Clinical Development, Biostatistics, RA, QA, etc.Support / Lead cross-functional study team meetingsCommunicate / Drive issue resolution across functionsBudget & Resource Management
Track / Manage study budgets and invoicesSupport / Own forecasting and resource planningIdentify / Mitigate cost and timeline risksIn order to be considered for the role, the selected candidate must have :
Degree in Life Sciences disciplinesRelevant experience in Clinical Operations phase 2 / 3 of small molecules drugs :
~3-5 years : Executes and tracks assigned Phase 3 operational tasks, maintains TMF and study documentation, and supports CRO and site communications.~5-7 years : Manages defined Phase 3 study components or regions, supports CRO oversight and issue resolution, and contributes to timelines and risk tracking.7+ years : Leads Phase 3 study execution end-to-end, owns CRO oversight, timelines, budget, and inspection readiness, and drives cross-functional issue resolution.Strong understanding of ICH-GCPVendor and stakeholder management and global trial experience desirableStrong organizational and communication skills in EnglishAbility to work in fast-paced, matrix environmentsThe selected candidate will be part of a dynamic team in an international environment and actively contribute to shape, develop, and drive the market authorization of innovative drugs. Hybrid work model (3 days onsite). Extension or take-over possibility.