Roles & Responsibilities
• Perform medical and scientific data review for hematology clinical trials (e.g., myeloma, lymphoma)
• Review standard data listings including adverse events, concomitant medications, efficacy and safety data
• Conduct patient profile reviews, safety narratives, PD analysis, and scientific data evaluations
• Support Lead Clinical Scientist and Medical Director in medical data review activities
• Develop and contribute to Medical Management Plans, Medical Data Review Plans, and Eligibility Review Plans
• Author medical data queries, review responses, and support query closure
• Participate in medical and safety review meetings, including slide preparation
• Collaborate with Clinical Operations, Data Management, Pharmacovigilance, and Project Management teams
• Identify data trends, risks, and subject safety issues; escalate concerns appropriately
• Ensure compliance with ICH-GCP, data privacy standards, SOPs, and regulatory requirements
• Support audits and trusted process meetings as required
Qualification
• Degree in Life Sciences: MSc, PharmD, PhD, MD, DMD or equivalent
Experience
• Relevant scientific or clinical research experience in clinical development
• Exposure to medical data review, clinical trials, or drug development preferred
Skills
• Strong understanding of clinical trial data, scientific principles, and ICH-GCP guidelines
• Excellent analytical, documentation, and problem-solving skills
• Strong written and verbal communication abilities
• Proficiency in MS Office (Word, Excel, PowerPoint)
• Ability to manage multiple tasks in a regulated, fast-paced environment
• Strong collaboration and stakeholder management skills
About the Organisation
Syneos Health® is a leading global biopharmaceutical solutions organization, supporting clinical development, medical affairs, and commercialization. With operations across 110+ countries and involvement in the majority of novel FDA and EMA approvals, Syneos Health partners with customers to accelerate the delivery of therapies that improve and save lives worldwide.
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