Central Monitor II

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🕒 July 7

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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

• Perform remote patient data review activities for Phase I-IV clinical research and/or non-interventional studies to assess compliance with the protocol, ICH-GCP, and applicable regulatory requirements • Ensure patient safety and data integrity using a variety of technologies • Review protocols and identify critical data, process, safety, and data integrity risks • Review patient data listings and visualizations to confirm eligibility and identify protocol deviations, patient safety concerns, data integrity issues, and inaccurate or missing data • Assess factors affecting subject/patient safety and clinical data integrity at investigator/physician sites • Communicate and escalate serious issues to the project team and develop action plans with guidance • Document observations and write queries, protocol deviations, or action items in appropriate systems • Access vendor systems or reports to verify investigational product administration, laboratory and other procedures, and current eTMF data • Document completion of activities through tracking, reporting, and required project documents • Manage patient- and site-level activities to meet project objectives, deliverables, and timelines • Adapt to changing priorities under the oversight of the Lead CRA/LCMDA • Prepare for and attend investigator and sponsor meetings • Participate in project staff meetings and clinical training sessions

🎯 Requirements

• Bachelor’s degree or RN in a related field, or equivalent combination of education, training and experience • Knowledge of Good Clinical Practice/ICH E6 (R2) Guidelines and/or other applicable regulatory requirements • Good computer skills and ability to embrace new technologies • Mastery of MS Excel, including sorting, filtering, calculating, and pivoting • Proficiency with analytical data visualization tools, including adjusting visualizations and selecting data subsets • Excellent verbal and written communication skills • Ability to inform, influence, and communicate cross-functionally • Strong analytical skills • Developing therapeutic expertise • Ability to travel less than 10%, limited to trainings and investigator meetings

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • Inclusive culture • Comprehensive resources including emerging technologies, data, science and knowledge sharing • Career paths and employment opportunities • Reasonable accommodations, when appropriate