22 sep
|
Innovaderm Research
|
Madrid
22 sep
Innovaderm Research
Madrid
Medical Monitor, Dermatology, Poland or Spain About The Position The Medical Monitor Dermatology provides medical and scientific support to clinical research programs.
The Medical
Monitor will perform thorough data review to ensure data integrity and subject safety oversight, and will communicate with sites, investigators, and internal project team members to ensure questions are promptly addressed. You are skilled in building positive working relationships with all stakeholders (clinical sites, colleagues, sponsors) in a clinical research project. You are able to interpret high volumes of data and situations efficiently, and take position and advise as necessary.
Protocols and projects More specifically, as required by the projects' scope of work, the Medical Monitor will: Develop or review Medical Monitoring plan. Provide project team training on study protocol and/or therapeutic area/indication. Provide 24-hour, 7 days a week, on-call (outside business hours) service for urgent safety-related matters.
Provides 24-hour, 7 days a week, on-call service for urgent trial-related safety issues, questions on the protocol, or other safety concerns.
Data Activities
Provide project-related medical consultation to the Innovaderm project team members during business hours throughout the duration of the study. Escalate to the Project Manager or Sponsor any issues requiring medical input and significant safety or data integrity concerns identified during review of data or site contact. Attend meetings with Innovaderm project team members (PM, DM,
stats, CRO) and/or Sponsor, as required.
Verify the medical accuracy of subject safety data and maintain an ongoing assessment of the safety profile of the study. Review subject safety-related data listings/tools for the purpose of identifying potential trends, unreported protocol deviations related to safety assessments, AEs, and SAEs; Review coding listings of adverse events, medical history, and concomitant medications to ensure all terms are coded properly. Participate in the Central Monitoring activities with site data signal detection and risk management activities for the safety portion; participate in the safety review for RBM and central monitoring.
Safety Medical
Monitoring and SAE Reporting Activities Participate in feasibility discussions relating to specific project proposals. Assist with drafting of standard operating procedures and working practices regarding Medical Monitoring activities.
Requirements Education Ability to organize and work efficiently on several projects, each with specific requirements and/or shifting priorities. Permanent full-time position. Home-based position. The successful candidate for this position is given to work remotely anywhere in Spain or Poland.
Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients.
📌 Monitor/a (remote) (Madrid)
🏢 Innovaderm Research
📍 Madrid