Clinical Trial Physician

3 weeks ago

Ahmedabad, India Theia New Consultancy Full time

The Clinical Trial Physician is responsible for providing medical input within the organization as well as to external partners and performing medical review tasks within the context of clinical trials. Furthermore, the Clinical Trial Physician is responsible for undertaking scientific/medical writing tasks within the organization.

Role & responsibilities

Is responsible for the development of:

  • All study related documents that fall under the Clinical Science Department scope (e.g., Study Protocols, ICFs - in collaboration with other departments e.g., Clinical Operations, Regulatory, as required -, Pharmacy Manuals, Medical Review Plans, etc.),
  • Scientific presentations and manuscripts,

  • Medical training material (i.e. therapeutic area and study protocol training material)

  • Delivers internal and external study protocol and therapeutic area training courses

  • Provides medical expertise and consultation within the Company on key therapeutic areas of the clinical development program
  • Provides guidance to all involved departments on the medical and scientific aspects of the assigned clinical trials/projects.
  • Responds to medical queries from all involved parties in assigned clinical trials (e.g., CRAs, Project Managers, Clinical Operations Managers, Investigators) and collaborates with all concerned staff in maintaining an up-to-date study-specific Q&A log
  • Is available 24/7 to respond to urgent medical/protocol related issues derived from an Investigational Site, as applicable
  • Performs periodic medical review of the data from clinical trials according to the study-specific Medical Review Plan requirements (e.g., review of eligibility, review of efficacy and safety data).
  • Performs real-time medical review on urgent medical and safety issues, as needed
  • Collaborates with and provides medical input to the Data Management staff to ensure the successful development of the study-specific eCRF
  • Attends Investigator Meetings and Conferences, as applicable
  • Complies with the Company's Quality and Information Security Management Systems and applicable national and international legislation, including legislation for data protection and ICH GCP requirements

Preferred candidate profile

  • Required Medical Degree (MBBS, MD)
  • Preferred: Clinical experience in the therapeutic area of the assigned study or of the Companys clinical development program - Preferred: 2 years of experience in a CRO or in the pharma industry in a relevant role (Clinical, Medical Information, Medical Affairs or PV)

Key competencies

  • Exceptional written and oral use of English
  • In-depth knowledge of medical and drug terminology
  • Good medical judgement and ability to make medical decisions
  • Excellent communication skills
  • Excellent business acumen
  • Initiative taking and team working attitude
  • Excellent Organizational skills
  • Innovative thinking
  • Excellent IT skills
  • Deep understanding of the Clinical Development industry

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