Medical Monitor, Dermatology
Location:
Poland or Spain
About The Position
The Medical Monitor Dermatology provides medical and scientific support to clinical research programs. Responsibilities include thorough data review to ensure data integrity and subject safety oversight, and communication with sites, investigators, and internal project teams to address questions promptly. This role is ideal for individuals skilled in building positive stakeholder relationships, balancing protocol requirements with trial realities, and interpreting high volumes of data to advise accordingly.
Responsibilities
1. Protocols and Projects:
Keep current on study protocol, amendments, Investigator’s Brochure, safety information, and guidelines. Develop or review Medical Monitoring plans, train project teams, and participate in investigator and safety review meetings. Provide 24/7 on-call support for urgent safety issues. Offer ongoing medical support to investigators and site personnel, advising on protocol-related issues, lab value reviews, medication impacts, and emergency unblinding.
2. Medical Advisory Role:
Serve as first-line contact for medical and safety questions, assess medication impacts, evaluate subject replacements, and provide medical input during meetings with project teams and sponsors.
3. Data Activities:
Provide medical consultation, escalate safety or data concerns, verify safety data accuracy, review safety-related listings, assess protocol deviations, and participate in safety monitoring activities.
4. Safety and SAE Reporting:
Review SAE forms and narratives, collaborate with pharmacovigilance, assist in safety committee activities, and support pharmacovigilance efforts.
5. Additional Duties:
Contribute to proposal development, develop SOPs, and perform other duties as assigned by the Chief Medical Officer.
Requirements
* Minimum 5 years of experience in clinical research within CRO, pharmaceutical, or biopharmaceutical settings.
* At least 3 years of experience as a medical monitor or in a similar role.
* Excellent knowledge of drug development and clinical practices.
* Strong communication, organizational, and interpersonal skills.
* Ability to work independently and within a team, managing multiple projects efficiently.
About Innovaderm
Innovaderm is a CRO specializing in dermatology, with a reputation for high-quality research since 2000. Based in Montreal, it expands across North America and Europe. The company values collaboration, innovation, reliability, and responsiveness, offering a stimulating environment, career growth, and remote work options. The position is remote in Spain or Poland, with accommodations available for disabilities. Applicants must be legally eligible to work in these countries.
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