Syneos Health is a fully integrated biopharmaceutical solutions organization that helps clients move therapies from clinical development to commercial delivery. Its teams combine clinical, medical affairs, commercial, technology, and market insights to address changing healthcare needs and support the development and launch of important treatments worldwide.
Clinical Scientist, Oncology Medical Monitoring
Support medical monitoring for Syneos Health oncology trials by reviewing clinical data, identifying safety risks, and helping study teams deliver trials. The role covers multiple indications and is remote within the United States.
Description
- Develop medical plans with the Medical Director, covering medical management, data review, and eligibility review.
- Consult external experts and advisors for medical and scientific input.
- Review data listings and visualizations on a scheduled and ad hoc basis.
- Analyze data for risks, patterns, and trends, and document medical reviews.
- Write medical data queries, assess responses, and approve query closure with the Medical Director.
- Support patient profile and study data reviews, protocol deviation assessments, and Medical Review Summary reports.
- Work with Medical Directors on medical and safety review meetings, including preparing slides.
- Oversee project scope, objectives, deliverable quality, milestones, and timelines.
- Coordinate medical data and eligibility reviews across internal teams, customers, and vendors.
- Work with study teams to detect data integrity and participant safety risks.
- Raise project concerns, threatened deliverables, and out-of-scope work with project leads.
- Attend Trusted Process meetings and take part in internal and external audits.
- Follow applicable data privacy, ICH, GCP, company, customer, and project requirements.
Requirements
- Understand active protocol designs, disease terminology, and pathology.
- Follow data privacy guidance, International Council for Harmonisation (ICH) standards, and Good Clinical Practice (GCP).
- Follow company and customer policies, standard operating procedures, work instructions, and project plans.
- Equivalent experience, skills, or education may be considered.
- Work with medical data review, eligibility review, data listings, and visualizations.
- Write medical data queries and review responses.
- Collaborate with Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Management teams.
Benefits
- Career development and advancement opportunities.
- Supportive, engaged line management.
- Technical and therapeutic area training.
- Peer recognition and a total rewards program.
- Company car or car allowance.
- Medical, dental, and vision coverage.
- Company matching contributions to a 401(k).
- Eligibility to participate in the Employee Stock Purchase Plan.
- Eligibility for commissions or bonuses based on company and individual performance.
- Flexible paid time off.
- Sick time.
- Reasonable accommodations when appropriate.