Clinical Trial Manager II

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

📋 Description

• Ensures that clinical monitoring tasks are executed to the satisfaction of the Sponsor, delivering quality results on time while adhering to relevant standard operating procedures (SOPs), regulations, good clinical practices, and specific study requirements;

• Identifies quality issues and trends concerning site performance and clinical monitoring activities through project meetings, communications with sites, site visit reports, follow-up letters, quality control visits, and findings from quality assurance audits. Compiles findings and formulates action plans to implement corrective measures;

• Acts as a primary contact for CRAs and Lead CRAs regarding assigned projects;

• Provides mentorship and oversight to CRAs and Lead CRAs;

• Reviews site visit reports for assigned projects and monitors site visit report metrics to ensure compliance;

• Contributes to the formulation of the Clinical Monitoring Plan;

• Prepares and delivers project-specific training sessions for CRAs;

• Develops annotated site visit reports and monitoring tools, including source data verification worksheets;

• Conducts quality control visits alongside CRAs;

• Organizes and leads CRA meetings;

• Participates in co-monitoring visits with CRAs;

• May engage in business development activities, such as client meetings, proposal defense sessions, requests for proposals (RFPs), and requests for information (RFIs);

⛳️ Requirements

• B.Sc. in a field relevant to clinical research, nursing degree, and/or equivalent experience;

• Minimum of 8 years of clinical research experience, including prior monitoring roles, with at least 2 years in a Lead CRA or Clinical Team Leader position within the biotechnology, pharmaceutical, and/or contract research organization (CRO) sectors;

• In-depth knowledge of ICH/GCP standards and relevant regulatory requirements;

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

• Ability to thrive in a fast-paced and evolving 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;

• Fluent in English, with excellent oral and written communication skills;

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

🏝️ Benefits

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