Medical Monitor, Rheumatology

Job not on LinkedIn

🔥 2 minutes ago

🌐 Argentina, Canada – Remote

infoinfo

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

Where this job comes from

Posted on Innovaderm Research Inc.'s careers page, not through a job board

First seen by Remote Rocketship 2 minutes ago

Logo of Innovaderm Research Inc.

Innovaderm Research Inc.

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, 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 • Provide project team training on study protocols and therapeutic areas • Prepare for, attend, and present at Investigators’ Meetings • Attend Safety Review Meetings as needed • Provide 24-hour, 7-days-a-week 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 medication • Review critical laboratory values and alerts • Assess prohibited medication impact and dropout subject replacement appropriateness • Provide emergency unblinding code-break of randomized treatment assignments • Provide medical consultation to the project team during business hours • Escalate medical issues and significant safety or data integrity concerns to the Project Manager or Sponsor • Attend project team and Sponsor meetings as required • Verify medical accuracy of subject safety data and assess the study safety profile • Review safety data, protocol deviations, coding listings, stopping rules, and clinical study reports • Participate in central monitoring, data signal detection, risk management, and safety review activities • Medically review SAE forms and Investigator-assigned SAE causality • Write or review SAE narratives • Work with pharmacovigilance providers or the Marketing Authorization Holder on SAE reviews and safety queries • Assist with pharmacovigilance activities and safety committee selection • Serve as a non-voting safety committee member and develop operating guidelines • Support business development through proposal development and sales presentations • Participate in project feasibility discussions • Assist with drafting Medical Monitoring SOPs and working practices • Perform other related duties as 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) • Rheumatology experience/knowledge • 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 shifting priorities • Excellent verbal and written communication and interpersonal skills • Client-focused approach to work • Good knowledge of good clinical practices • Legally authorized to work in Argentina

🏖️ 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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