Global Clinical Operational Specialist - 12 months (T2404)

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.

Join our dynamic Global Clinical Operations team at our vibrant Headquarters in Lausanne

 Global Clinical Operational Specialist – 12 months contract

In this role, you will be a member of the dynamic Global Clinical Trial Team, playing a vital role in the successful delivery of our global clinical trials. As a dedicated and detail-oriented professional, you will be entrusted with responsibility of overseeing and executing various operational activities throughout the entire lifecycle of a clinical trial. Working closely with the esteemed Clinical Trial Leader, you will have the unique opportunity to contribute to the groundbreaking advancements in our field.

Your responsibilities will be but not limited to:

• Coordinate and participate in Global Clinical Trial Team meetings and prepares meeting minutes, and tracks and follows up on outstanding actions.
• Ensure all delegated operational trial deliverables are met according to timelines, budget, operational procedures, and quality standards.
• Set up and maintain accurate trial information in tracking systems and communication tools for updating the relevant internal/external boards (e.g., Core Team, Development Leadership Team, and Core Team). You train and provide guidance to Clinical Trial Team members in the use of these systems.
• 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 Specialist on the set-up, maintenance, close-out and archiving of the Trial Master File. You coordinate regular quality check and review of TMF ensuring continual inspection readiness.
• Set up and maintain clinical trial insurance in participating countries.
• Establish and maintain trial-related processes/systems (e.g., central laboratories, interactive response technologies (IRT), clinical supplies, etc.) with the CRO/vendors as assigned per protocol requirements.
• Manage and oversee the activities of the CRO/vendors as assigned including the interactions between the Clinical Trial Team and the CRO/vendors.
• Assist in the tracking, processing, and reconciliation of invoices from the CRO/vendors and generating purchasing order according to the CRO/vendor contracts.
• Lead the arrangement and contribute to the preparation of external meetings e.g., monitor meetings, investigator meetings, and advisory boards.
• Ensure trial inspection/audit readiness and participate in internal audits and inspections as required.
• Prepare and distribute trial related correspondence and contribute to and distribute materials for meetings, newsletters, and websites.
• Contribute to process improvement or acts as Subject Matter Experts for training or SOPs.

• Bachelor’s Degree or Master’s Degree in Science or Healthcare
• With at least 3 years of experience in the pharmaceutical industry, specifically in international clinical research
• Strong knowledge of Good Clinical Practice and the complete clinical trial process, including the interfaces
• Previous experience working on anti-infectives or oncology studies is highly desirable
• Familiarity with Veeva Vault is a strong plus
• Ability to work effectively in a matrix organization and demonstrate strong collaboration skills
• Excellent organizational skills, with the ability to coordinate and prioritize multiple tasks and deliverables
• Highly flexible with strong verbal and written communication skills in English – fluency in any other 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.