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Clinical Research Physician/Sr Clinical Research Physician

051495_2

About the role

This vacancy has now expired. Please click here to view live vacancies.

Looking for CRP/Sr CRPs for ICON Chennai or Trivandrum. Freshers or candidates with experience in medical affairs or Pharmacovigilance with a Medical degree can apply.

The role would involve reviewing and approving final study reports or other clinical documents among other reposnisbilities

 

PURPOSE OF THE JOB:

  • Provide medical leadership on project teams
  • Provide medical/scientific consultation and therapeutic expertise including QPPV (EU)
  • Oversee study specific medical/safety monitoring activities, ensuring compliance with ethical, legal, and regulatory standards as well as ICON and Sponsor SOPs
  • Represent the Medical Affairs Department in business development activities
 JOB FUNCTIONS/RESPONSIBILITIES:
  • Serve as medical team leader on assigned projects
  • Ensure provision of all contracted activities and identification of out of scope activities on projects assigned
  • Provide medical monitoring for clinical studies
  • Provide medical oversight for serious adverse event reporting and tracking, and communication of safety issues to ICON staff, sponsors, and regulatory authorities
  • Oversee and provide consultation for lab report review, CRF safety review, and potential endpoint reporting, for clinical projects
  • Coordinate and provide medical training including indication training, protocol training, safety presentations for ICON clinical staff, project teams, or during investigator meetings
  • Review and approve protocols, case report forms, informed consent forms (when applicable), and other miscellaneous study documentation
  • Coordinate review and approval of serious adverse event narratives
  • Review and approve final study reports or other clinical documents
  • Direct code-break activities (as appropriate)
  •  Act as QPPV (EU) as assigned
  • Serve as part of the medical management team
  • Supervise, develop and mentor lower level Medical Affairs and Drug Safety staff as assigned by the Regional Vice President
  • Represent ICON Medical Affairs at teleconferences and meetings
  • Liaise with Sponsors regarding medical issues and medical consultation
  • Ensure quality of medical deliverables in accordance with project plans and ICON standards
  • Represent Medical Affairs in business development activities including general capabilities presentations, bid defenses, medical costing estimates, and change order assumptions
  • Assist senior medical management in ensuring departmental revenue and margin targets are met
  • Provide input for monthly status reports, departmental activities, and project / performance related issues to the Director / Senior Director / Regional Vice President / Senior Vice President Medical Affairs
  • Other activities as identified and requested by senior

QUALIFICATIONS/EXPERIENCE REQUIRED:

  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Medical Degree and broad based post-graduate experience
  • Medical board certification (preferred)
  • Two years (minimum) industry experience as a Clinical Research Physician or other equivalent experience
  • Ability and willingness to travel approximately 10% of the time or as required
  • Excellent communication skills
  • Excellent presentation skills
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