Central Report Reviewer - Clinical Trials
Central Report Reviewer - Clinical Trials
Syneos Health
Job description
Looking to build a career in clinical monitoring, quality, and oversight? Explore this Central Report Reviewer role at Syneos Health, based remotely in India.
Company Description
Syneos Health is a fully integrated life sciences services company created to help customers succeed faster. It works with people who are coming up with ideas in drug development and selling medicines. The company helps them deal with situations and get things done quicker. In the past five years, it has helped 94 percent of all new medicines that got approval from the FDA. The company has 29,000 employees. They all have the same goal: Driven to Deliver.
Job Summary
This remote position in India is part of the Clinical Solutions team at Syneos Health. As a Central Report Reviewer, you will review site and central monitoring reports and letters. Your job is to check that these reports correctly show site activity. You will also. Flag any risks that could affect patient safety, data quality, or Good Clinical Practice rules. You will record changes in CTMS. Report serious concerns to your managers.
Key Responsibilities
Perform central report review as per the monitoring strategy, focusing on patient safety, rule compliance, and data integrity.
Please review the content and quality of site monitoring papers and central monitoring papers. For example, check site monitoring calls, visit reports, site letters, and central monitoring reports.
Make sure these papers show site management and trial conduct correctly and flag any risks.
Record requested changes and approvals in CTMS.
Deliver reviews on time according to company and sponsor needs.
Check for factors that may affect safety and data integrity. Look for protocol deviations, special sponsor needs, and pharmacovigilance issues.
Quickly pass issues to the Clinical Trial Manager or Project Manager.
Record findings and ensure protocol deviations and action items are logged in the right systems.
Support annotated visit reports such as PSV, SIV, IMV, COV, and SCAN when needed.
Check CRA report quality, risks, and trends. Share a summary for review.
Join monitoring and project meetings and training sessions.
Support Clinical Trial Manager tasks, such as protocol deviation and action item management.
Educational Qualification
Bachelor's degree or RN in a related field, or an equivalent mix of education, training, and experience.
Skills Required
Clinical trial experience in site management is preferred.
Study management experience, such as Lead CRA or similar, is preferred.
Knowledge of Good Clinical Practice, ICH guidelines, and other rules.
Good documentation habits and strong attention to detail.
Good computer skills and the ability to learn new tools.
Good communication and people skills to work with the project team and sites.
Critical thinking and problem-solving skills to find the cause of issues and the right fix.
Ability to work in an international setting.
Salary Structure
The estimated annual salary of a Central Monitor at Syneos Health typically ranges from ₹4.7 Lakhs to ₹7.3 Lakhs per year, depending on experience.
Career Development
This role gives you hands-on experience in clinical monitoring oversight. Syneos Health says it helps you grow through career development, supportive managers, and technical and therapeutic training.
How to Apply
Visit our job portal and search for the Central Report Reviewer role at Syneos Health.
Click on the job posting to see all the details about the job.
Enter your information and add your resume.
Send your application.
Education
Bachelor's Degree
Key Skills
Market insights & trends
Salary Insights
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Hiring Trends
The number of jobs for this profile is going up every year. Hospitals and other healthcare companies are looking for people who're good, at their job and can also figure out new problems. They want who can do the work and also think on their feet to deal with the challenges of working in healthcare today.