Senior Clinical Trial Manager: Lead Programs & Submissions

LimmaTech Biologics AG; Zürich; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

LimmaTech Biologics AG in Switzerland is seeking a Clinical Project Manager (100%) to lead and manage clinical trials and programs, including Phase I/II studies. The role focuses on scope, quality, timeline and budget adherence, with emphasis on high-quality study documentation and regulatory submissions.

You will coordinate CROs, sites, and vendors, plan visits and trainings, and ensure data integrity and accurate reporting, while driving risk mitigation and development plans in a fast-paced,

Qualifikationen

• Master’s or PhD in Life Sciences and 5+ years in clinical operations.
• Led and managed clinical trials or programs, ideally Phase I/II.
• Experience in selection and management of CROs, sites, vendors and consultants.
• Strong planning, communication and regulatory submission experience.

Aufgaben

• Manage clinical trials to ensure adherence to scope, quality, budget and timelines.
• Prepare high quality clinical study documentation (protocols, study plans, reports, ICFs, manuals).
• Identify risks, assess impact, and drive mitigation strategies.
• Plan and conduct site initiation visits, monitoring visits, investigator meetings, trainings and KOL interactions.
• Manage regulatory submissions per requirements and timelines.
• Conduct data reviews and resolve data queries; support data integrity activities.
• Oversee CROs, sites, vendors and consultants to ensure performance.
• Manage trial budgets and negotiate contracts for cost efficiency.
• Shape development plans and regulatory strategies to achieve program objectives.
• Ensure compliance with ICH-GCP and local regulations; update SOPs.

Kenntnisse

Hands-on clinical trial management

Planning & communication

ICH-GCP familiarity

English communication

Ausbildung

Master’s or PhD in Life Sciences

Jobbeschreibung

LimmaTech Biologics AG in Switzerland is seeking a Clinical Project Manager (100%) to lead and manage clinical trials and programs, including Phase I/II studies. The role focuses on scope, quality, timeline and budget adherence, with emphasis on high-quality study documentation and regulatory submissions.

You will coordinate CROs, sites, and vendors, plan visits and trainings, and ensure data integrity and accurate reporting, while driving risk mitigation and development plans in a fast-paced,