Company: Indero
Location: Remote – Germany, Spain, or Poland
Employment Type: Permanent | Full-Time
Experience Required: Minimum 5+ years in clinical research within CRO, pharmaceutical, or biopharmaceutical organizations
About the Role
Indero, a global contract research organization (CRO) specializing in dermatology and rheumatology, is seeking a Medical Monitor to provide medical and scientific oversight across clinical trials in Europe. This role ensures subject safety, protocol adherence, and high-quality data integrity, while serving as the primary medical contact for investigative sites, study teams, and sponsors.
The ideal candidate is a medically trained professional with extensive experience in dermatology and rheumatology trials, skilled in collaborating with cross-functional teams, interpreting complex clinical data, and providing timely guidance on safety and protocol-related issues.
Key Responsibilities
Clinical Oversight & Protocol Management
Maintain up-to-date knowledge of study protocols, amendments, Investigator’s Brochures, and safety updates.
Develop or review Medical Monitoring Plans tailored to study requirements.
Provide study-specific training to project teams on protocol and therapeutic areas.
Participate in Investigator Meetings, Safety Review Meetings, and other key study discussions.
Serve as a 24/7 on-call resource for urgent safety and protocol-related matters.
Advise sites on subject eligibility, prohibited medications, follow-up visits, and safety concerns.
Evaluate the need for subject replacement and perform emergency unblinding if required.
Medical Advisory & Stakeholder Support
Act as the first point of contact for investigators, site staff, and clinical monitors on safety and protocol issues.
Provide guidance on adverse events, serious adverse events (SAEs), and protocol deviations.
Collaborate with Pharmacovigilance teams or Marketing Authorization Holders (MAH) to review SAEs and follow-up on outstanding safety queries.
Support safety committee activities as a non-voting member, including guideline development and procedural oversight.
Data Review & Quality Assurance
Conduct comprehensive review of subject safety data, including adverse events, lab critical values, and concomitant medications.
Identify potential trends, protocol deviations, or safety concerns and escalate to project managers or sponsors as necessary.
Verify coding accuracy for adverse events, medical history, and concomitant medications.
Participate in central monitoring and risk-based monitoring (RBM) activities.
Support the preparation of Clinical Study Reports (CSRs) and other regulatory documents.
Business Development & Process Support
Assist in feasibility discussions, proposal development, and client presentations.
Contribute to drafting and updating SOPs and internal medical monitoring procedures.
Support ongoing training and development of internal medical monitoring teams.
Required Qualifications
Education:
Medical degree (MD or equivalent).
Residency in Dermatology is an asset.
Experience:
Minimum 5 years in clinical research within a CRO, pharmaceutical, or biopharmaceutical organization.
At least 3 years in a role as Medical Monitor, Medical Reviewer, or Drug Safety Physician in clinical trials.
Skills & Competencies:
Deep understanding of ICH-GCP and global regulatory guidelines (FDA, EMA).
Strong clinical judgment, problem-solving, and decision-making skills.
Ability to manage multiple concurrent studies with varying requirements and priorities.
Excellent interpersonal, communication, and collaboration skills within matrix teams.
Client-focused approach with attention to quality and compliance.
Proficiency in Microsoft Word, Excel, and PowerPoint.
Work Environment & Benefits
Home-based, flexible work schedule within Germany, Spain, or Poland.
Permanent full-time employment.
Opportunities for continuous professional learning and global exposure.
Collaborative and innovative CRO environment with international project teams.
About Indero
Indero (formerly Innovaderm) is a leading global CRO specializing in dermatology and rheumatology. Since 2000, the organization has delivered high-quality clinical research services, including study design, clinical monitoring, medical monitoring, pharmacovigilance, and biostatistics. With operations across Europe, North America, Asia Pacific, and Latin America, Indero provides comprehensive, scientifically rigorous solutions for biotech and pharmaceutical sponsors.
Equal Opportunity Statement
Indero provides equitable treatment and accommodates applicants with disabilities throughout the recruitment process. Only candidates legally authorized to work in Europe (Germany, Spain, or Poland) will be considered.
Apply Today – Advance your career as a Medical Monitor in a global dermatology and rheumatology CRO and contribute to high-impact clinical research programs across Europe.
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