Clinical Affairs Program Manager - Europe

The Clinical Affairs Program Manager – Europe is part of InSightec Global Clinical Affairs Management team and is responsible for execution of Global Clinical Affairs studies in Europe. In particular, the Clinical Affairs Program Manager – Europe is responsible to develop strategies for a successful execution of roadmap clinical trials that demonstrate medical product safety and efficacy. Additional responsibilities include management of clinical trials approvals with local IRBs and/or Competent Authorities. 

Responsibilities:

  • Collaborate with Company Stakeholders to execute company objectives into successful clinical trials, investigator-sponsored studies, etc.
  • Overall responsibility for design of clinical trials including protocol development, clinical trial discussions with EU Competent Authorities, and development of timeline and budget
  • Manage the process of screening/qualifying, selecting, and contracting with investigators, sites and vendors required for conduct of clinical trials
  • Direct/Manage necessary clinical trial approvals from IRBs/ECs, and ensure studies are on track for site initiation, patient recruitment and enrollment; take corrective actions where necessary to address issues
  • Develops budget for all clinical projects and adhere to company financial goals
  • Ensure clinical results are interpreted and documented clearly and concisely for regulatory submissions and publications
  • Develop, maintain and expand collaborations with Company Stakeholders, clinical investigators and researchers, and key opinion leaders to optimize the clinical development programs
  • Participate in the development of SOPs and work instructions to assure internal files and clinical study files (patient; site; country) conform to Good Clinical Practice regulations and standards
  • Ensure adherence to protocols and compliance with regulatory (FDA/ICH/ISO/GCP) guidelines as well as SOP procedures
  • Identify clinical training needs and develop training materials for in-house and clinical site use

 

Skills and Experience:

  • BS, BA, BSN or RN or higher degree in the Life Sciences or related disciplines
  • Minimum 3+ years in clinical management position in biopharmaceutical or device industry, Clinical Research Organization Biopharmaceutical experience would provide a strong advantage
  • Additional 4+ years direct experience in clinical trial management
  • Solid track record in successfully executing Phase I – III clinical trials
  • Demonstrated expert knowledge and comprehensive understanding of applicable GCP, ICH, ISO guidelines.  FDA and or Health Canada experience would provide a strong advantage
  • Strong, hands-on manager with experience in managing Core Labs, data management, biostatistics, and medical safety reporting
  • Knowledge of electronic data capture systems and web-based clinical trial management tools
  • Excellent interpersonal, written / verbal communication & organizational skills
  • Excellent command of the English language; both written and verbal.  Additional language beside native language is a significant advantage
  • Collaborative team player with strong abilities to operate independently
  • Strong program management and financial skills
  • High level computer skills required (e.g. MS Word, Excel, PowerPoint)
  • Willing & able to travel domestically and internationally, as required (up to 40%)

* Only qualified applicants will be considered

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