Roles & Responsibilities:
• Perform medical and scientific data review for hematology clinical trials (e.g., myeloma, lymphoma).
• Review standard data listings, adverse events, concomitant medications, patient profiles, and efficacy/safety data.
• Support Lead Scientist in medical data review, including protocol deviations, PD analysis, and Medical Review Summary reports.
• Collaborate with Medical Directors to develop medical plans (Medical Management Plan, Data Review Plan, Eligibility Review Plan).
• Author and review medical data queries, approve query closure, and participate in data review and safety meetings.
• Serve as liaison between internal teams, customers, and vendors on medical data and eligibility review.
• Collaborate with Clinical Operations, Data Management, Drug Safety, and Project Management to identify data integrity and subject safety risks.
• Adhere to ICH/GCP guidelines, data privacy policies, SOPs, and customer-specific procedures.
Qualification:
• Degree in Life Sciences (MSc, PharmD, PhD, DMD, MD) or equivalent.
Experience:
• Relevant scientific experience in clinical trials, medical review, or clinical data management.
Skills:
• Strong scientific and analytical skills for medical data review.
• Excellent written and verbal communication skills.
• Proficient in MS Office (Excel, Word, PowerPoint).
• Knowledge of drug development, ICH/GCP guidelines.
• Ability to manage multiple tasks, prioritize, and work in cross-functional teams.
• Self-starter, adaptable to changing priorities and timelines.
About the Organisation:
Syneos Health is a fully integrated biopharmaceutical solutions organization that accelerates the delivery of therapies through clinical development, medical affairs, and commercial insights. With 29,000 employees across 110 countries, Syneos Health partners with clients to optimize clinical trial outcomes, streamline drug development, and ensure scientific integrity while fostering an inclusive and collaborative work culture.
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