Clinical Operations project Manager – (Part time) – 6866 URA
We are seeking a temporary and part time Clinical Operations Project Manager to support a Phase I clinical development program and a regulatory registration project related to EMEA submission. The Project Manager will act as a central coordination point, ensuring alignment between internal stakeholders and external institute partners, with strong focus on milestones, tracking, and communication. This role is based in Swiss Romandy area and can be done remotely from anywhere in Switzerland.
This role is not a regulatory specialist position, but a project management role in a regulatory and clinical environment .
Key Responsibilities
Act as Single Point of Contact (SPOC) for external institute partners.
Centralize and coordinate all incoming project-related requests.
Support coordination of EMEA registration activities and responses to regulatory questions.
Ensure timely tracking, follow-up and escalation of actions and deliverables.
Manage project milestones, timelines and dependencies.
Support Phase I clinical trial activities (UK-based project).
Perform gap analysis and ensure implementation of action plans.
Ensure TMF completeness and compliance.
Prepare and maintain project documentation (plans, status reports, dashboards).
Drive effective cross-functional communication with internal and external stakeholders.
Work closely with the Regulatory Manager on planning and milestone delivery.
Identify risks and issues and propose mitigation strategies.
Ensure alignment of stakeholders on priorities and timelines.
Qualifications
Relevant working/residency permit or Swiss/EU-Citizenship required
Bachelor’s degree in Life Sciences or related field (or equivalent).
At least 4 years of hands‑on experience managing operational aspects of all phases of clinical trials within pharmaceutical industry,
Familiarity with International Conference on Harmonization‑Good Clinical Practice (ICH‑GCP) guidelines.
Experience with electronic data capture systems (e.g., eTMF, CTMS).
Proven experience working in cross‑functional, multicultural teams.
Demonstrated experience in selecting and managing external service providers, including performance assessments and finance management.
Excellent communication skills in English.
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