Report Reviewer

Job Description

Position: Report Reviewer Department: Clinical Operations Location: Ahmedabad Key Responsibilities Prepare and finalize the visit report annotation as per protocol and study plans. Ensure finalization of the visit reports as per timeline mentioned in contract, study plans & SOPs. Effectively review trip reports as per annotated report, protocol & SOPs. Ensure the quality of reports are of the highest standards, consistent across sites and visits, errors are minimized and those issues are escalated as appropriate. To follow up on open action items and protocol deviations and coordinate with team for timely resolution of issues. To act as an extension of the CTM/CTM team for the specific purpose of visit report review To observe and escalate safety trends in patients as identified in visit reports Where required, attend project meetings and actively provide suggestions for improvement of quality of reports, provide feedback for timely and appropriate resolution of action items and report trends Ensure all necessary trainings, required to improve job performance and knowledge, are completed in a timely manner Any other responsibility assigned by HOD/Project Manager. Qualifications & experience required University Life sciences degree or related field. At least 3 to 5 years of clinical trial-related experience including on-site monitoring experience, CRO working experience is preferred. Adequate knowledge of new product development, including local regulation, GCP, clinical trial operations. Fluent written and verbal communication skills including good command of English language. Ability to handle conflicting priorities. Attention to detail and accuracy in work. Results-oriented approach to work towards delivery and output and strong problem-solving skills. Good software and computer skills, including MS Office applications including but not limited to Microsoft Outlook, Word, Excel and PowerPoint.