Clinical Trial Manager II, Dermatology, Rheumatology

This is a fully remote position, open to applicants in United States.

📋 Description

• Manage and supervise clinical investigative sites as well as clinical monitoring deliverables for clinical trials.

• Ensure that clinical monitoring activities meet sponsor expectations and adhere to SOPs, regulations, good clinical practices, and specific study requirements.

• Identify and analyze quality issues and trends related to site performance and monitoring activities.

• Summarize findings and develop corrective action plans.

• Act as a primary contact for CRAs and Lead CRAs on assigned projects.

• Mentor and supervise CRAs and Lead CRAs.

• Review site visit reports and monitor compliance metrics.

• Contribute to the development of the Clinical Monitoring Plan.

• Prepare and deliver project-specific CRA training.

• Create annotated site visit reports and monitoring tools, including source data verification worksheets.

• Conduct quality control visits alongside CRAs.

• Organize and lead CRA meetings.

• Participate in co-monitoring visits with CRAs.

• Engage in business development activities, such as client meetings, proposal defense meetings, RFPs, and RFIs.

⛳️ Requirements

• A Bachelor's degree in a field related to clinical research, nursing, or equivalent experience.

• A minimum of 8 years of clinical research experience, including prior monitoring experience.

• At least 2 years of experience in a Lead CRA or Clinical Team Leader role within the biotechnology, pharmaceutical, or CRO industry.

• Strong understanding of ICH/GCP standards and relevant regulatory requirements.

• Proficient in Microsoft Office suite (Word, Excel, PowerPoint).

• Ability to thrive in a fast-paced, evolving environment while fostering positive relationships with colleagues, sites, and sponsors.

• Exceptional leadership, organizational, time management, and multitasking abilities.

• Strong judgment and problem-solving capabilities.

• Willingness to travel occasionally, up to 10% of the time, including potential international travel.

• Fluent in English, demonstrating excellent oral and written communication skills.

• Experience in a CRO and in the field of dermatology is a plus.

• Must possess legal authorization to work in the US.

🏝️ Benefits

• Flexible work schedule.

• Home-based position.

• Continuous learning and development opportunities.

• Attractive career advancement prospects.