Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.
Report Reviewer
Location
India
Posted
8 days ago
Salary
0
Seniority
Senior
Job Description
Report Reviewer
Syneos Health
• Responsible for execution of Central Report Review activities on the study • May support development of annotated visit reports • Reviews the content and quality of site and central monitoring documentation • Ensure deliverables are provided according to company and/or sponsor specifications • Documents observations noted during reviews and ensures protocol deviations or action items are reported as necessary
Job Requirements
- Monitoring strategy defined, with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity
- Development of annotated visit reports such as PSV, SIV, IMV, COV & SCAN
- Reviews the content and quality of site and central monitoring documentation
- Document requested revisions and approvals in CTMS
- Assess factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site
- Immediately communicates/escalates serious issues to Clinical Trial Manager/Project Manager
- Documents observations noted during reviews
- May assesses CRA/CM report quality, risks, and trends as well as operational performance and summarizes the findings for CTM review and action planning
- Participates in clinical monitoring/project staff meetings and attends clinical training sessions according to the project specific requirements
Benefits
- We are passionate about developing our people, through career development and progression
- supportive and engaged line management
- technical and therapeutic area training
- peer recognition and total rewards program
- We are committed to building an inclusive culture – where you can authentically be yourself
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