Global Clinical Trial Manager Oncology Early Phase (Temporary 12 months)
Debiopharm Group, Switzerland

Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and bacterial infections in order to improving 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. Bridging the gap between disruptive discovery products and real-world patient reach, we 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.

Here: https://apply.workable.com/debiopharm-group-sa/

Debiopharm International S.A. identifies high-potential compounds for in-licensing, conducts clinical development and then selects large pharmaceutical commercialization partners to maximize patient access across the globe.

To support our Clinical Operations Department based in Lausanne, Switzerland, we are looking for 12 months mission:

Global Clinical Trial Manager Oncology Early Phase (Temporary 12 months)

The temporary Global Clinical Trial Manager (CTM) reports to the Manager, Clinical Operations and, is responsible and accountable for leading, planning, implementing and delivering international clinical trials in early Phases (Phases I/II) in Oncology, to ensure that studies are carried out according to the protocol, SOPs, applicable regulations and principles of Good Clinical Practice.

Your key responsibilities, on behalf of Debiopharm:

• Lead the overall initiation, coordination, implementation and management of international clinical trials at different stages during mission duration

• Lead the cross functional study team dedicated to the clinical study to ensure clinical program goals and timelines are met
• Manage operational and technical aspects of projects including budgeting, timelines and risk management
• Anticipate potential issues and risks within the clinical program, create contingency plans and drive solution implementation
• Manage and coordinate external vendors, such as Contract Research Organizations (CROs), central laboratories, etc. You may be involved in the selection process, depending on study status
• Monitor vendor and CROs performance and ensure continuous oversight
• Assist in the identification of investigational sites and coordinate co-monitoring with CRAs when required
• Represent clinical operations on multi-function project teams internally and externally, if needed; report on study progress
• Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines, alert in case of deviations or risks, and propose mitigation plans
• Ensure the delivery of the clinical study according to ICH GCP (E6-R2), local applicable regulations and company’s specific SOPs
• Provide operational input (and scientific if appropriate) into Protocol synopsis, Study protocol and all other study related documents
• Design, review and approve of all trial related documentation, and establish trial processes

Requirements

• University degree or equivalent in Life Sciences.
• Proven track record of 5-7 years of experience as Clinical Trial Manager or comparable operating experience in Pharma with good knowledge of budget and invoicing requirement, as well as drug development process and medical terminology
• Experience in phase I-II studies is a must; experience in pharmacokinetic studies (e.g. DDI, ADME) is an asset
• Experience in one or the following disease areas: Oncology, Rare Diseases or Orphan Drugs
• Experience in Management and Filing of Trial Master File (Veeva Vault knowledge is a plus)
• Customer oriented and strong team-spirit with the ability to foster a collaborative team environment and to work effectively with others in a fast-paced matrix organization
• Capable of anticipating obstacles and bottlenecks and acting as a problem solver with a sense of urgency
• Experience in external audits, an asset
• Strong negotiation skills, scientific knowledge and involvement
• Former experience in contributing to protocols and clinical development plans
• Fluent in English French is an asset

Benefits

• An international and highly dynamic environment, with a long term vision.
• 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

Job Rewards and Benefits