Central Report Reviewer

Syneos Health India Private Limited; India; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Syneos Health India Private Limited is seeking a Central Report Reviewer to ensure accurate execution of central monitoring and reporting activities across studies, emphasizing patient safety, protocol/GCP compliance, and data integrity.

Applicants should have clinical trial site management experience, knowledge of regulatory requirements, strong documentation habits, and excellent communication with cross-functional teams to support CTM and project delivery.

Qualifications

• Previous clinical trial experience in site management and clinical preferred
• Preferred experience in study management (as Lead CRA or equivalent)
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Good documentation habits and skills, strong attention to detail
• Must demonstrate good computer skills and the ability to learn new technologies
• Good communication and interpersonal skills among project team and with sites
• Demonstrates critical thinking and problem solving techniques to determine the cause and appropriate solution in the identification of issues

Responsibilities

• Execute Central Report Review activities per the monitoring strategy with focus on patient safety and data integrity
• Review site and central monitoring documentation to ensure accurate representation of site activities and risks
• Escalate serious safety issues to CTM/Project Manager as needed
• Document observations and action items in appropriate CTMS systems
• Support CTM activities such as protocol deviation management and action items tracking
• Participate in project meetings and trainings to maintain up-to-date project status knowledge

Skills

CRA experience

Clinical trial

Documentation

Communication

Problem solving

Attention to detail

Education

Bachelor's degree or RN in related field

Job description

Central Report Reviewer Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success.

We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.

We are agile and driven to deliver - for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 future colleagues already know:

Why Syneos Health

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.

Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life.

- We are continuously building the company we all want to work for and our customers want to work with.

Why?

Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities

Responsible for execution of Central Report Review activities on the study based on the - Monitoring strategy defined, with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity. May support development of annotated visit reports such as PSV, SIV, IMV, COV & SCAN.

• Reviews the content and quality of site and central monitoring documentation (site monitoring calls, site visit reports, site letters, central monitoring reports and pertinent correspondence), to ensure they represent site management activities and conduct and that they appropriately convey any risks to protocol/GCP compliance, trial conduct, patient safety or data integrity. Document requested revisions and approvals in CTMS. Ensures these deliverables are provided according to company and/or sponsor specifications, including delivery deadlines.
• Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations/special Sponsor's requirements and pharmacovigilance issues documented in the report. Immediately communicates/escalates serious issues to Clinical Trial Manager/Project Manager
• Documents observations noted during reviews and ensures protocol deviations or action items are reported as necessary in appropriate systems for action by CRA/CM or other functional team members.
• May assess 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. Involves in regular project discussion and email correspondence to maintain the most up-to‑date project status knowledge and progression. Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations.
• May support in CTM activities such as Protocol Deviation management, Action Items management, etc.

Additional Qualifications

Bachelor's degree or RN in a related field or equivalent combination of education, training and experience Capable of working in an international environment skills

• Previous clinical trial experience in site management and clinical preferred
• Preferred experience in study management (as Lead CRA of equivalent)
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Good documentation habits and skills, strong attention to detail
• Must demonstrate good computer skills and the ability to learn new technologies
• Good communication and interpersonal skills among project team and with sites
• Demonstrates critical thinking and problem solving techniques to determine the cause and appropriate solution in the identification of issues

Get to know Syneos Health

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-changin