Senior Clinical Trial Manager

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

📋 Description

• Oversee the operational management and supervision of clinical investigative sites as well as the clinical monitoring deliverables associated with clinical trials.

• Ensure that clinical monitoring tasks are conducted to meet the Sponsor’s expectations, delivering quality results in a timely manner.

• Detect quality issues and trends related to site performance and clinical monitoring operations.

• Compile findings and develop action plans for necessary corrective measures.

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

• Provide mentorship and guidance to CRAs and Lead CRAs.

• Review site visit reports for the projects assigned.

• Contribute to the formulation of the Clinical Monitoring Plan.

• Design and deliver project-specific training for CRAs.

• Create annotated site visit reports and monitoring tools.

• Conduct quality control visits in collaboration with CRAs.

• Organize and facilitate CRA meetings.

• May participate in business development initiatives.

⛳️ Requirements

• Bachelor’s degree in a relevant field related to clinical research, nursing qualification, and/or equivalent experience.

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

• At least 2 years of experience in a Lead CRA or Clinical Team Leader position within the biotechnology, pharmaceutical, and/or contract research organization (CRO) sectors.

• Extensive knowledge of ICH/GCP standards and relevant regulatory requirements.

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

• Capability to thrive in a fast-paced, dynamic environment while building strong relationships with colleagues, sites, and sponsors.

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

• Strong judgment and problem-solving skills.

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

• Fluency in English (both oral and written) is essential.

• Experience in a CRO and familiarity with dermatology is a plus.

🏝️ Benefits

• Flexible work schedule / work arrangement: Home-based position.