Clinical Research Physician

vor 1 Monat

Basel, Schweiz Pharmiweb Vollzeit

RBW Consulting are partnered with a global Biopharma who specialise in the discovery, development and commercialization of innovative small molecules, with the aim of transforming the horizon of therapeutic options, in their search for a Contract Clinical Research Physician.

The Clinical Research Physician will play a key role in a large global phase 3 cardiovascular outcome study. In addition to the responsibilities described below, the CRP will be specifically responsible for the implementation of the study-specific patient training strategy. The tasks and activities of the Clinical Research Physician will be carried out in close collaboration with the study Clinical Trial Scientist, the Clinical Lead and Cardiovascular Medical Expert.

This role is for 1 FTE on an initial 12 month contract, with 1-2 days per week in the Allschwil office. The rate for this position is CHF 77.96 per hour.

Responsibilities

  • Providing the medical leadership internally for the trial activities assigned, through a comprehensive understanding of the science, medicine, product environment and competitive landscape relating to a disease area
  • Delivering the medical aspects of the Clinical Project Development Plan related to the indication and overseeing its implementation
  • Contributing to the core medical/scientific information required in all clinical documents of the respective trial (e.g. protocols, core informed consent forms, clinical study reports, safety related documents etc.) and assure production of high-quality documents
  • Supporting the Clinical lead by contributing to global strategic development and providing evidence-based input to clinical project-related, strategic and regulatory documents
  • Writing protocol amendments and other study related documents such as the Informed Consent Form (ICF), committee(s) charter(s), subject narratives and the Clinical Study Report (CSR)
  • Delivering medical oversight of the study (including safety, medical review of data during the trial, quality and performance of the trial)
  • Interpreting Clinical Trial data and present conclusions and action plan(s) to Clinical Development Management team
  • Managing contacts with external Experts, National Coordinating Trainers (NCTs) and study site investigators
  • Answering to trial-related EC/IRB and HA questions
  • Developing a sound understanding of the science and medicine relating to the therapeutic area
  • Developing a sound understanding of the complexity of global clinical development with an attention to methodological and ethical aspects of development, in the assigned therapeutic area
  • Performing literature reviews and write position papers as necessary
  • Delivering medical training to the study teams' members and staff and protocol-related training to study sites

Requirements

  • MD
  • At least 2 years' experience in clinical research in a Pharmaceutical and/or Biotech company or equivalent in Academia preferably within cardiovascular therapeutic area
  • Experience in patient education is a plus
  • Good knowledge of drug development and clinical trial process based on previous experience
  • Good knowledge of regulatory requirements/ICH guidelines
  • Good organizational and communication skills, able to work as part of a team and independently
  • Proven record of successfully engaging and interacting within a complex and challenging matrix organization as well as with all levels of seniority
  • Results driven attitude and good sense of urgency
  • Able to anticipate and proactively address issues and demands, solution oriented and hands-on
  • Analytical thinking, data and detail oriented
  • Shares knowledge and expertise openly
  • Excellent written and spoken communication skills in English

Please apply here and Harry Henson will be in touch to discuss your application further

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