Report Reviewer

🔥 26 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

✨ Reviewer

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Execute Central Report Review activities on studies according to the monitoring strategy, focusing on patient safety, protocol/GCP/regulatory compliance and data integrity • Support development of annotated visit reports such as PSV, SIV, IMV, COV and SCAN • Review the content and quality of site and central monitoring documentation, including site monitoring calls, site visit reports, site letters, central monitoring reports and pertinent correspondence • Document requested revisions and approvals in CTMS and ensure deliverables meet company and/or sponsor specifications and deadlines • Assess factors affecting subject/patient safety and clinical data integrity, including protocol deviations, violations, sponsor requirements and pharmacovigilance issues • Immediately communicate or escalate serious issues to the Clinical Trial Manager or Project Manager • Document review observations and report protocol deviations or action items in appropriate systems • Assess CRA/CM report quality, risks, trends and operational performance, and summarize findings for CTM review and action planning • Participate in clinical monitoring/project staff meetings and clinical training sessions • Maintain current project status knowledge through project discussions and email correspondence • Support CTM activities such as Protocol Deviation management and Action Items management

🎯 Requirements

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience • Capable of working in an international environment • Previous clinical trial experience in site management and clinical preferred • Preferred experience in study management, such 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 • Good computer skills and ability to learn new technologies • Good communication and interpersonal skills among project team and with sites • Critical thinking and problem-solving skills • Understanding of protocol, SOPs, ICH GCP and country regulations

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture • Reasonable accommodations for applicants with disabilities, when appropriate