Clinical Trial Operations Manager

vor 1 Woche


Bern, Bern, Schweiz Lindus Health Vollzeit
Company Overview

Lindus Health is a pioneering software company that empowers innovative companies to run faster, more reliable, and patient-friendly clinical trials. Our mission is to revolutionize the clinical trial infrastructure and make new medicines more accessible to patients.

Job Description

We are seeking an experienced Clinical Trial Operations Manager to join our dynamic team. As a key member of our Clinical Operations department, you will be responsible for leading and managing the day-to-day running of clinical trial programs and projects.

You will act as the primary liaison between Lindus Health and sponsors, ensuring project launch, conduct, and closeout align with contractual agreements. Your role will involve coordinating activities and deliverables of project partners, identifying and managing issues, and maintaining project information on various databases and systems.

As a Clinical Trial Operations Manager, you will also be responsible for project management components of inspection readiness, including Trial Master Files. You will develop contingency plans and risk mitigation strategies to ensure successful delivery of project goals.

Required Skills and Qualifications
  • Meaningful experience working on German and/or French clinical trials
  • Strong knowledge of Good Clinical Practice/ICH guidelines, regulatory requirements, drug development process, and clinical monitoring procedures
  • More than 4 years' experience managing and coordinating clinical trials from end to end in a project management and/or clinical operations role
  • Experience conducting study start-up and EC/IRB applications
  • Able to use different software for the delivery of clinical trials and adapt to using new technology to change trial processes
  • Experienced in decentralized/remote trials, multi-site, and IND/CTIMP trials
Benefits
  • Unlimited holidays; everyone encouraged to take off at least 28 days each year
  • 60 EUR monthly wellness allowance for wellhub membership, wellness activities, or personal expenses
  • Enhanced parental leave: 16 weeks full pay for primary caregiver and 6 weeks full pay for secondary caregiver
  • 1000 EUR learning and development allowance each year for courses, certifications, and development


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