Sr Clinical Research Physician
About the role
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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
Application process
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Reasonable AccomodationsDay in the life
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