Clinical Research Physician/Sr Clinical Research Physician

  • Company:
    ICON PLC
  • Location:
  • Salary:
    negotiable / month
  • Job type:
    Full-Time
  • Posted:
    2 weeks ago
  • Category:
    Healthcare | Biotechnology/Pharmaceutical/Medicine

Skill: regulatory , pharmacovigilance , crf , clinical documents , drug safety , medical affairs , clinical , clinical research; Exp: 0-3 years; Clinical Research Physician/Sr Clinical Research Physician India-Chennai Permanent Reference 051495 Description 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 PERCENT 25 of the time or as required Excellent communication skills Excellent presentation skills

Clinical Research

Degree: 

Experience: 0-3

Function: Biotech / Pharma / R&D