Global Clinical Operational Manager
vor 20 Stunden
Description
Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to develop innovative therapies that target high unmet medical needs. Our unique “development only” business model allows us to act as a bridge between disruptive discovery products and patient access in international markets. We first identify high-potential compounds for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally.
At Debiopharm you will be at the forefront of the fight against cancer and infectious diseases, and you will have the opportunity to work on new innovative medicines for patients. Efficiency is our mode of action, saving lives our collective target.
For our Global Clinical Operations organization based at our Headquarters in Lausanne, we are looking for a
Global Clinical Operational Manager
(Maternity Cover - 8 months)
**Your responsibilities will be but not limited to**:
Organizes, coordinates, and participates the Clinical Trial Team meetings including agenda/minutes preparation, and actions tracking and follow-up.
Leads/contributes to the development and maintenance of the trial level documents and CRO/vendor trial operational plans.
Establishes and maintains trial-related processes/systems with the CRO/vendors as assigned per protocol requirements.
Contributes to risk and issue identification, development of mitigation and/or actions for the identified risks and issues.
Sets up and maintains accurate trial information in tracking systems and communication tools to monitor the trial progress and to update the relevant internal/external boards.
Develops and oversees the execution of IRB/IEC submission plan for initial protocol and its amendment(s) for the trial.
Works in collaboration with Clinical Team Members and TMF Lead/Specialist on the set-up, maintenance, close-out and archiving of the Trial Master File
Sets up and maintains clinical trial insurance in participating countries.
Leads the arrangement and contributes to the preparation of external meetings e.g., monitor meetings, investigator meetings, and advisory boards.
Supports Clinical Trial Lead with budget management such as forecast and accrual. Assists in the tracking, processing, and reconciliation of invoices from the CRO/vendors and generating purchasing order according to the CRO/vendor contracts.
**Requirements**:
Bachelor’s/Master’s Degree in Science or Healthcare.
5 years in the pharmaceutical industry, with 3 years in clinical trials.
Excellent knowledge of Good Clinical Practice and the end-to-end trial process.
Strong communication, leadership, organizational, and project management skills.
Analytical mindset, innovative, and solution-driven.
Proficient in computer skills.
Fluency in English; knowledge of French and another European language is an asset.
**Benefits**:
The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry and be exposed to many areas within clinical development and the pharmaceutical industry
The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success
Proud to be an Equal-Pay certified, we ensure offering to all our employees the same opportunities
Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external staffing agency or recruiter does not create any implied obligation on the part of Debiopharm.
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