Description
*Debiopharm is privately-owned Swiss biopharmaceutical company commitmented to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Debiopharm International SA aims to develop innovative therapies via our unique -development only- business model, acting as a bridge between disruptive discovery products and patient access in international markets. At Debiopharm you will be at the forefront of the fight against cancer and infectious diseases through working on innovative medicines for patients. Join our team at Debiopharm where together, we innovate, we impact, and we grow.*
For our Global Clinical Operations organization based at our Headquarters in Lausanne, we are looking for a
**Global Clinical Operational Manager**
**Your responsibilities will be but not limited to:**
* Being a core member of Clinical Trial Team (including deputizing the Clinical Trial Leader during his/her absence), you organize, and participate the Clinical Trial Team meetings, maintain and facilitate interactions within Clinical Trial Team and external functions including the CRO/vendors.
* Lead & contribute to the development and maintenance of the trial level documents and CRO/vendor trial operational plans.
* Establish and maintain trial-related processes/systems with the CRO/vendors as assigned. You oversee and address CRO/vendor performance during the trial conduct.
* Contribute to risk and issue identification, development of mitigation and/or actions for the identified risks and issues.
* Set up and maintain accurate trial information in tracking systems and communication tools to monitor the trial progress and to update the relevant internal/external boards.
* Develop and oversee the execution of IRB/IEC submission plan for initial protocol and its amendment(s) for the trial.
* Work in collaboration with Clinical Team Members and TMF Lead/Specialist on the set-up, maintenance, close-out and archiving of the Trial Master File.
* Set up and maintain clinical trial insurance in participating countries.
* Prepare and distribute trial related correspondence, and contribute to & distribute materials for meetings, newsletters, and websites.
* Lead the arrangement and contribute to the preparation of external meetings e.g., monitor meetings, investigator meetings, and advisory boards.
* Support Clinical Trial Lead with budget management such as forecast and accrual, and assist in the tracking, processing, and reconciliation of invoices from the CRO/vendors and generating purchasing order according to the CRO/vendor contracts.
* Take the role of a Clinical Trial Lead as assigned in clinical trial and leads the cross-functional Clinical Trial Team to operationalize the protocol.
* Bachelor-s/Master-s Degree in Science or Healthcare.
* 5 years in the pharmaceutical industry, with 3 years in clinical trials Phase 1 and 2 at the sponsor
* Experience on Oncological trials is an asset
* 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.
* Possibility to work from home 2 days/week
* 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
*The use of external staffing agencies or recruiters requires prior approval from our Human Resources Department. The Human Resources Department at Debiopharm requests external staffing agencies or recruiters not to contact Debiopharm employees or members of the Board of Directors directly in an attempt to present candidates.*
*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.*
*Debiopharm will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions.*