Associate Director / Lead Global Clinical Trial Management - Phase III

Lausanne, Vaud, SwitzerlandFull time

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Description

Debiopharm Group™ is a Swiss-headquartered global biopharmaceutical group active in the life science areas of drug development, GMP manufacturing of proprietary drugs, diagnostic tools and investment management. Debiopharm International SA is focused on the development of prescription drugs that target unmet medical needs. The company in-licenses and develops promising drug candidates. The products are commercialized by pharmaceutical out-licensing partners to give access to the largest number of patients worldwide.

For our Clinical Operations Department based at our Headquater in Lausanne, we are looking for a

Associate Director / Lead Global Clinical Trial Management - Phase III (100%)

The Associate Director / Lead Clinical Trial Management (CTM) Ph III trials is responsible and accountable for leading, planning, implementing and delivering large international Phase III clinical trials in Oncology and onco-haematology, to ensure that studies are carried out according to the protocol, SOPs, applicable regulations and principles of Good Clinical Practice.

Associate Director / Lead Clinical Trial Management leads planning and management of the assigned clinical study from an end-to-end trial management perspective to achieve Global Program Team objectives. Acts as Study Team Lead representative at Core Team level. Enables an empowered organization, which can navigate in a matrix environment and adjust quickly to business needs. Point of escalation for resolution of trial management operational issues within assigned program.

Your responsibilities will be but not limited to:

• Lead the overall initiation, coordination, implementation and management of large international Phase III clinical trials from start-up to close out.


• Lead the cross functional study team dedicated to the clinical study to ensure clinical program goals and timelines are met, and drive timely and efficient program execution according to the approved development plan;


• Manage operational and technical aspects of projects including budgeting, study initiation and risk management;


• Anticipate potential issues and risks within the clinical program, create contingency plans and drive solution implementation;


• Select, manage and coordinate external vendors, such as Contract Research Organizations (CROs), central laboratories, etc;


• 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; 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.


• Fluent in English – French and another European language are an asset.


• Oncology experience required.


• Proven track record of successful management of large complex Phase III international clinical trials in the Pharmaceutical Industry or CRO. Previous monitoring experience preferred.


• Ability to lead and influence a cross-functional study team and external partners.


• Strong experience in management of CROs, vendors and consultants.


• Deep knowledge and experience on the implementation and use of EDC, IWRS, eTMF, CTMS and any other digital clinical trial systems.


• Strong project management skills.


• Excellent budgeting, planning, and communication skills.


• Capable of anticipating obstacles and bottlenecks and acting as a problem solver with a sense of urgency.


• Strong negotiation skills.


• Strong scientific knowledge and involvement.


• Former experience in contributing to protocols and clinical development plans.


• High degree of initiative and ability to work independently.


• Experience in external audits, an asset.


• Willingness to travel according to business needs (10-30%).


• Working knowledge of Microsoft Word, Excel, PowerPoint and Outlook


• Technology-savvy in all Microsoft Office 365 applications;


• Ability and willingness to handle special projects.


• Demonstrate excellent written and verbal communication skills in English

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 its success.

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