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Clinical Research PhysicianRef: MC25174

Salary:Negotiable

Added:15 Oct 2020

Region: Europe

Sector: Pharmaceutical

Sub Sector: Physicians

All tasks below should be performed in compliance with Good Clinical Practices and our clients Sop's. The CTP is a member of the Clinical Trial Team (CTT). The tasks and activities of the CTP are carried out in close collaboration with the Clinical Trial Scientist (CTS) for the trial related activities and with the Clinical Project Physician (CPP) and Clinical Project Scientist (CPS) for the project related activities.

  • Develop a sound understanding of the science and medicine relating to the therapeutic area
  • Develop a sound understanding of the complexity of global clinical development with a particular attention to methodological and ethical aspects of development, in the assigned therapeutic area
  • Perform literature reviews, and write position papers as necessary
  • Contribute to writing of the Clinical Trial Protocol including amendments and related documents such as the Informed Consent Form (ICF), committee(s) charter(s), subject narratives and the Clinical Study Report (CSR)
  • Ensure that the Case Report Form is designed to allow careful and comprehensive collection of data
  • Deliver medical training to the Clinical Trial Team (CTT) members and/or our clients staff
  • Deliver medical oversight of the study (including safety, medical review of data during the trial, quality and performance of the trial)
  • Interpret Clinical Trial data
  • Manage contacts with external Experts, Steering Committees (SC), Independent Data Monitoring Committees (IDMC), other study or project committees
  • Answer to trial-related EC/IRB and HA questions

Candidate's Requirements:

  • MD
  • At least 4 years' experience in clinical research in a Pharmaceutical or Biotech company or equivalent in Academia
  • Clinical research or clinical experience in the indication relevant to the clinical project is preferred
  • Good knowledge of drug development and clinical trial process based on previous experience
  • Good knowledge of regulatory requirements/ICH guidelines
  • Detail oriented
  • Fluent in English (written and oral)

Behavioral Skills:

  • Good organizational, problem solving, and interpersonal and communication skills
  • Ability to work independently and within a cross-functional team to prioritize and coordinate multiple competing tasks
  • Ability to work under pressure and meet short timelines without compromising quality
  • Results driven attitude and good sense of urgency
  • Able to anticipate and proactively address issues and demands
  • Analytical thinking, data and detail oriented
  • Shares knowledge and expertise openly
  • Effectively negotiates with key stakeholders to influence, convince, and gain their buy-in and agreement

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