Endpoint Adjudication Specialist Lead
18 hours ago
Syneos Health is a leading biopharmaceutical solutions organization dedicated to accelerating customer success.
Job DescriptionThe Endpoint Adjudication Specialist Lead will provide operational support to the MCAM Manager and project team members across scoped services, including attending committee meetings, preparing meeting materials, and filing project documents.
You will review clinical event/endpoint documentation to ensure completeness, redact Protected Health Information (PHI), and identify potential unreported endpoints or events requiring adjudication.
In addition, you will manage translation services, distribute Safety Listings and Expedited Safety Reports for review, initiate queries to sites for discrepant or missing data, and support User Acceptance Testing (UAT) of Committee's collaborative workspace and/or electronic adjudication platform.
This role requires a strong understanding of Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) guidelines and other applicable regulatory requirements.
Required Skills and Qualifications- A BS in life sciences, Medicine, Pharmacy, Nursing, or related field, or an equivalent combination of education and experience.
- Prior experience in study coordination, contract research organizations (CROs), pharmaceutical, or biotechnology companies is preferred.
- Strong organizational and time management skills, as well as excellent communication and interpersonal skills, are required.
- Knowledge of MS Office Applications and proficiency with full MS Office Applications is essential.
We offer a competitive annual base salary ranging from $63,000 to $122,400, a company car or car allowance, health benefits, a 401(k) plan, commissions/bonus opportunities based on performance, and flexible paid time off.
Join Our TeamWe believe in providing an environment and culture where our employees can thrive, develop, and advance. If you are passionate about delivering exceptional results and making a meaningful impact, we encourage you to explore this opportunity.
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