Senior Clinical Trial Manager – Dermatology & Rheumatology CRO | Romania
Company: Indero
Location: Romania (Home-Based)
Employment Type: Permanent | Full-Time
Industry: Clinical Research | CRO | Dermatology | Rheumatology
Experience Required: Minimum 8+ years in clinical research, including 2+ years in Lead CRA or Clinical Team Leadership roles
Job Overview
A leading global Contract Research Organization specializing in dermatology and rheumatology clinical trials is seeking a Senior Clinical Trial Manager (CTM) to oversee clinical monitoring operations and site performance across assigned projects in Romania.
This senior-level role is responsible for the operational management of investigative sites and clinical monitoring deliverables, ensuring compliance with ICH-GCP guidelines, sponsor SOPs, and applicable regulatory requirements. The Senior CTM will drive monitoring excellence, oversee CRA performance, manage quality oversight processes, and ensure timelines and deliverables are achieved.
This opportunity is ideal for experienced clinical research professionals who have successfully managed monitoring teams within CRO environments and are looking to further develop therapeutic expertise in dermatology and rheumatology.
Key Responsibilities
Oversee clinical monitoring activities to ensure delivery meets sponsor expectations, regulatory requirements, and project timelines.
Identify site performance trends and quality issues through monitoring reports, audit findings, and project meetings.
Develop corrective and preventive action plans to address compliance gaps.
Serve as the primary escalation point for CRAs and Lead CRAs on assigned studies.
Provide leadership, mentorship, and oversight to CRAs and Lead CRAs.
Review site visit reports and track compliance metrics.
Contribute to the development and implementation of Clinical Monitoring Plans.
Design and deliver project-specific CRA training programs.
Develop annotated visit report templates and monitoring tools, including SDV worksheets.
Conduct co-monitoring and quality control visits.
Lead and coordinate CRA meetings.
Support business development activities including client meetings, RFPs, RFIs, and proposal defense meetings when required.
Required Qualifications
Education:
Bachelor of Science degree in Life Sciences, Nursing, or a related clinical research field.
Equivalent professional experience may be considered.
Experience:
Minimum 8+ years of clinical research experience within biotech, pharmaceutical, or CRO environments.
Prior hands-on monitoring experience required.
At least 2+ years in a Lead CRA, Clinical Team Leader, or equivalent oversight role.
Experience within a CRO setting strongly preferred.
Dermatology experience is considered a significant advantage.
Core Competencies
Advanced knowledge of ICH-GCP standards and global regulatory frameworks.
Strong leadership and team management capabilities.
Excellent organizational, time management, and multi-tasking skills.
Ability to analyze quality trends and implement corrective strategies.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
Strong communication skills in English (written and verbal).
Ability to work effectively in fast-paced, evolving project environments.
Occasional travel required (up to 10%), including potential international travel.
Work Environment & Benefits
This is a home-based position in Romania offering:
Flexible work schedule
Ongoing professional development and learning opportunities
Exposure to global dermatology and rheumatology clinical programs
Collaborative mid-sized CRO environment with direct leadership access
About the Organization
Indero is an established Contract Research Organization specializing in dermatology clinical research since 2000. Headquartered in Montreal, the company has built a strong international reputation for scientific rigor, operational excellence, and client-focused delivery across North America and Europe.
With expanding expertise in dermatology and rheumatology, the organization delivers full-service clinical trial solutions, including monitoring, project management, biometrics, pharmacovigilance, and regulatory consulting.
Equal Opportunity Statement
The organization is committed to equitable employment practices and provides reasonable accommodations during the recruitment process upon request.
Applicants must be legally authorized to work in Romania.
Apply via ThePharmaDaily.com
If you are an experienced Clinical Trial Manager with strong monitoring oversight experience and leadership expertise within CRO environments, apply now through ThePharmaDaily.com to advance your career in global dermatology and rheumatology clinical research.
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