Medical Monitor, Dermatology

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🔥 5 minutes ago

🇵🇱 Poland – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

👻 Ghost score 12%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Innovaderm Research Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

💊 Pharmaceuticals

🏥 Healthcare

💼 Consulting

Pharmaceuticals • Healthcare • Consulting

Innovaderm Research Inc. is a Contract Research Organization (CRO) specialized in dermatology, providing scientific guidance and conducting Phase I to IV clinical trials in the field. With a strong presence in North America and Europe, Innovaderm offers a comprehensive range of services including study design, regulatory consulting, project management, patient recruitment, and data management, ensuring high-quality research outcomes and customer satisfaction since 2000.

📋 Description

• Provide medical and scientific support to clinical research programs • Perform thorough data review to ensure data integrity and subject safety oversight • Communicate with clinical sites, investigators, sponsors, and internal project team members • Keep current on study protocols, amendments, Investigator’s Brochure, safety information, and relevant clinical research guidelines • Develop or review Medical Monitoring plans • Train project teams on study protocols and therapeutic areas • Prepare for, attend, and present at Investigators’ Meetings • Attend Safety Review Meetings as needed • Provide 24/7 on-call service for urgent safety-related matters • Provide ongoing medical support to investigators, site personnel, and monitors • Advise sites on protocol-related issues, eligibility criteria, concomitant medications, medical conditions, follow-up visits, and prohibited medications • Review laboratory critical values and alerts • Assess prohibited medication impact and appropriate subject action • Evaluate dropout subject replacement • Provide emergency unblinding code-break of randomized treatment assignment • Provide medical consultation to Indero project team members • Escalate issues requiring medical input and significant safety or data integrity concerns • Attend meetings with project teams and sponsors • Verify medical accuracy of subject safety data and assess the study safety profile • Review safety data listings, protocol deviations, coding listings, stopping rules, and clinical study reports • Participate in central monitoring, site data signal detection, risk management, and safety review activities • Medically review SAE forms and investigator causality assessments • Write or review SAE narratives • Collaborate with pharmacovigilance providers or Marketing Authorization Holders on SAE review and safety queries • Assist with pharmacovigilance activities and safety committee member selection • Serve as a non-voting safety committee member and develop operating guidelines • Support business development, proposal development, sales presentations, and feasibility discussions • Assist with standard operating procedures and working practices • Perform other related duties assigned by the Chief Medical Officer

🎯 Requirements

• Medical degree • Minimum of 2 years of relevant experience in clinical research in a CRO, dermatology clinical trials, pharmaceutical, or biopharmaceutical company (Medical Monitor, Medical affairs, Medical Director, Safety) • Dermatology experience • Excellent knowledge of the drug development process • Ability to work in partnership with a multidisciplinary group of colleagues, including translating concepts into practical approaches and promoting consensus • Ability to work independently with minimal supervision and effectively within a team and matrix environment • Ability to organize and work efficiently on several projects with specific requirements and/or shifting priorities • Excellent verbal and written communication and interpersonal skills • Client-focused approach to work • Good knowledge of good clinical practices • Must be legally able to work in Europe

🏖️ Benefits

• Flexible work schedule • Permanent full-time position • Ongoing learning and development • Attractive advancement opportunities • Accommodations throughout the recruitment and selection process for applicants with disabilities, upon request

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