
10,000+ employees
đĽ Healthcare
đź Consulting
đŚ 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.
đ August 7
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10,000+ employees
đĽ Healthcare
đź Consulting
đŚ 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.
⢠Serve as a Clinical Data Reviewer and identify data errors through data review per the Data Review Plan ⢠Perform ongoing review of clinical and medical aspects of study participant data and documents ⢠Escalate relevant issues to the Syneos/client Clinical Scientist and/or Study Medical Director ⢠Issue clinical data queries and ensure timely follow-up and resolution after site responses ⢠Communicate sponsor data training needs and concerns for CRAs and sites ⢠Provide clinical data review project-management status and expert data review and cleaning support ⢠Maintain focus on data quality and audit readiness with Clinical Compliance and Systems Validation Compliance ⢠Assist with data-capture requirements guidance aligned with protocol and reporting requirements ⢠Monitor site data-entry performance and provide information for root-cause analysis and remedial actions ⢠Improve task efficiency and the quality of data deliverables ⢠Contribute to EDC completion training, clinical data review meetings, data dissemination materials, and presentations when needed ⢠Collaborate with Syneos/client clinical and data functions throughout study conduct, including data cuts, interim analyses, DSURs, IBs, regulatory requests, site close-outs, and final database lock ⢠Contribute to QC review of patient narratives
⢠Equivalent experience, skills, and/or education will be considered ⢠Expertise in clinical/medical data review and cleaning ⢠Ability to review clinical/medical aspects of study participant data and documents ⢠Ability to issue, follow up, close, and re-query clinical data queries ⢠Ability to collaborate with Clinical Scientists, Study Medical Directors, Data Management, and Clinical Operations ⢠Knowledge of clinical trial data, including patient eligibility, diagnosis, medical history, prior treatments, study drug administration, AE/SAE/AESI, concomitant medications, dosing/compliance, safety labs, efficacy assessments, coding, and related data ⢠Ability to monitor site data entry performance and identify root causes of data issues ⢠Ability to ensure audit readiness and resolve clinical data compliance issues ⢠Ability to contribute to EDC completion training, data review meetings, data dissemination meetings, and patient narrative QC ⢠Ability to support data reviews before snapshots, interim analyses, DSURs, IBs, regulatory requests, site close-outs, and final database lock
⢠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 and employees with disabilities
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