Clinical Operations (d/f/m)

- Globally operating pharmaceutical company - Temporary assignment for 12-24 months **About Our Client** For our client, a globally renowned pharmaceutical company in the Basel area, we are seeking a Clinical Operations professionals to strengthen the team in 2026 in support of Phase 3 development activities. The contract duration is 12-24 months and is open to candidates with 5+ years of relevant experience across different seniority levels. Depending on the selected candidate's performance and motivation, the possibility of an extension or a permanent take over. **Job Description** 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 deliverables - Support / Lead vendor selection, onboarding, and oversight (CROs, central labs, IRT, imaging) - Track / Manage CRO performance, metrics, and issue resolution - Escalate / Resolve operational risks and deviations **Site Management & Monitoring Oversight** - Support / Coordinate / Lead site management activities through CRO or internal monitors - Track / Ensure site activation, enrollment, and retention performance - Support / Manage site issues, protocol deviations, and compliance concerns - Review / 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 readiness - Support / Lead GCP compliance activities - Support / Participate in audits and inspections **Cross-Functional Collaboration** - Coordinate / Lead interactions with different internal stakeholders e.g. Clinical Development, Biostatistics, RA, QA, etc. - Support / Lead cross-functional study team meetings - Communicate / Drive issue resolution across functions **Budget & Resource Management** - Track / Manage study budgets and invoices - Support / Own forecasting and resource planning - Identify / Mitigate cost and timeline risks **The Successful Applicant** **In order to be considered for the role, the selected candidate must have:** - Degree in Life Sciences disciplines - Relevant 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-GCP - Vendor and stakeholder management and global trial experience desirable - Strong organizational and communication skills in English - Ability to work in fast-paced, matrix environments **What's on Offer** The 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. **Contact: Kamila Fotiou** **Quote job ref: JN-122025-6909331** Quelle: https://ch.linkedin.com/jobs/view/clinical-operations-d-f-m-at-michael-page-4345186842

Level: mid level