Sr. Clinical Trial Manager (1 year fixed term contract)

Lausanne, Vaud, Switzerland · Clinical Research & Development

Description

The Sr. Clinical Trial Manager (CTM) is reporting to the Director, Clinical Operations and, is responsible and accountable for leading, planning, and delivering clinical trials (Phases I–III) 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.

Requirements

Your responsibilities :

  • Manage the cross functional study team dedicated to the clinical study to ensure clinical program goals and timelines are met;
  • Manage operational aspects of projects including budgeting, study initiation and risk management;
  • Select and manage external vendors, such as Contract Research Organizations (CROs), central laboratories, etc.;
  • Assist in the identification of investigational sites and perform 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;
  • Give operational input (and scientific if appropriate) into Due Diligence activities.
  • Your profile :

  • University degree or equivalent in Life Sciences.
  • Fluent in English, French and another European language are an asset.
  • Oncology experience highly preferred.
  • Proven track record of Phase I-III international clinical trials management in the Pharmaceutical Industry or CRO. Previous monitoring experience preferred.
  • Deep knowledge and experience on the implementation and use of EDC, IWRS, eTMF, CTMS and any other digital clinical trial systems.
  • Experience in management of CROs, vendors and consultants.
  • Experience in external audits, an asset.
  • 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.
  • Ability to lead and influence a cross-functional study team and external partners.
  • Strong negotiation skills.
  • Strong scientific involvement.
  • Former experience in contributing to protocols and clinical development plans.• High degree of initiative and ability to work independently.• Willingness to travel according to business needs (10-30%).
  • Benefits

    Debiopharm International can offer you:

  • An international and highly dynamic environment.
  • The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry.
  • The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success.
  • Apply for this job