Syneos Health
10,000+ employees
🧬 Biotechnology
💊 Pharmaceuticals
⚕️ Healthcare Insurance
Biotechnology • Pharmaceuticals • Healthcare Insurance
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.
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Syneos Health
10,000+ employees
🧬 Biotechnology
💊 Pharmaceuticals
⚕️ Healthcare Insurance
Biotechnology • Pharmaceuticals • Healthcare Insurance
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
• 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
🎯 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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