Protocol Manager

Protocol Manager

Bristol-Myers Squibb

Munich, Germany

Area of ​​Responsibility:

  • Demonstrates a strong operational understanding of conducting clinical trials (both interventional and non-interventional, late phase (medical Phase IV) & Investigator Sponsor Research);
  • Able to coordinate or contribute to key clinical documents (e.g. Protocol, ICF, CRFs ...);
  • Can manage all aspects of global company sponsored studies from start to end;
  • Demonstrates flexibility and is able to manage studies across organization (i.e. multiple TAs) & different study types (i.e. NIR, Late Phase, ISR);
  • Demonstrates cultural awareness and ability to manage studies across geographies;
  • Ability to identify potential barriers to study completion and implement effective strategies that facilitate study conduct;
  • Interacts and communicates effectively with different groups including Local Medical, HQ Medical, Field Medical Science, GHEOR, CORDS, GPVE, GCT-SU, GRS, Global Biostatistics, GCR, GCO, and Legal;
  • Ability to mentor, train and/or educate junior, or new employees;
  • CRO/vendor management and RFP experience;
  • Able to manage study budget;
  • Able to assist in establishing and implementing departmental standard practices and processes;
  • Contract management and Project management.

Requirements:

  • 5 years of experience working within the pharmaceutical industry;
  • MSc or equivalent, with strong science background: Nurse, Pharm D, PhD;
  • Strong working knowledge of Oncology and/or Immunoscience;
  • Experience of NIR & ISR is an advantage;
  • Demonstrates the ability to drive clinical trial activities. (i.e. experience in the design, conduct and management of clinical trials and experience in working with Contract Research Organizations (CROs) or external vendors (IVRS/IXRS);
  • Demonstrated ability to multi-task and manage high performance demands;
  • Experience on international studies management;
  • Knowledge of clinical research including its processes, procedures and timelines;
  • Knowledge of the pharmaceutical industry and of the clinical, regulatory and legal components;
  • Strong knowledge of good clinical practices (GCP), and ICH Guidelines;
  • Adequate knowledge of specific local/regional regulations (EU-CTD), when leading local/regional projects (e.g. Early Patient Access, Named Patient Programs, Investigator Sponsored Research).

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© EuroJobsites 2019

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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