Sr Clinical Research Physician

Looking for a Sr CRP for ICON Chennai or Trivandrum. 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

• 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