Medical Data Review Manager – Rheumatology

• Review structured clinical patient data output without direct access to medical charts to ensure medical plausibility, protocol adherence, completeness, and readiness for the next level of review
• Identify anomalies in patient-reported data requiring investigation with clinical sites
• Review inclusion and exclusion criteria for clinical trial patient acceptance
• Review investigational product dosing records for protocol adherence and inaccurate or missed dosages
• Review Adverse Events, Concomitant Medication, and medical history information for completeness, plausibility, supporting information, and protocol adherence
• Ensure end-of-treatment and end-of-study information is correctly documented
• Review laboratory results for completeness, protocol schedule adherence, and potential unreported safety conditions
• Review other information as necessary to determine readiness for next-level review
• Interact with Medical Review staff to verify information and triage data issues or action items
• Attend kick-off meetings, weekly team meetings, and client meetings as needed or requested

• Specialization in Rheumatology, certified (mandatory)
• Bachelor's Degree in Medicine, graduated and specialized in Rheumatology (mandatory; only physicians considered)
• 5 years of related experience in clinical research at research site level or CRO/Pharmaceutical companies
• Experience as Sub-Investigator or Principal Investigator considered relevant
• Advanced English level and strong communication skills in English
• Understanding of clinical/medical data related to clinical trials
• Background in Medical Terminology, Pharmacology, Anatomy, and Physiology
• Excellent motivational, influencing, and coaching skills
• Ability to work on multiple projects and manage competing priorities
• Strong customer focus skills
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients

• Home-based work arrangement
• Global scope position