Clinical Team Manager

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Lead assigned clinical teams, including Clinical Research Associates (CRAs).

• Create, review, and modify clinical trial documents, such as Clinical Monitoring Plans.

• Assist project managers with study Key Performance Indicators (KPIs), timelines, budgets, invoicing, and approval of staff time.

• Contribute to clinical risk management, Critical to Quality Factors, and Quality Tolerance Limits.

• Suggest investigators and sites, and review and approve Pre-Site Visit (PSV) reports.

• Supervise site initiations, supply management, activation documentation, CRA assignments, and visit schedules.

• Organize internal project team meetings and provide updates on study status and protocol deviations.

• Aid in the setup and maintenance of trial master files while overseeing ongoing and final quality control.

• Examine CRA site visit reports to ensure timely and high-quality completion.

• Manage investigational products and study supplies.

• Review data listings and query reports, identify trends, and implement mitigation or retraining actions.

• Oversee documentation, tracking, escalation, and corrective/preventive actions for protocol deviations and study non-compliance.

• Serve as the site contact in the absence of CRAs and escalate unresolved issues to project management.

• Supervise tasks performed by clinical staff, including approval of CRA travel.

• Manage activities related to trial close-out.

• Communicate and collaborate effectively with sponsors, investigators, partners, and cross-functional teams.

• Support strategies for patient recruitment and retention.

• Coordinate the preparation for site audits and inspections, overseeing corrective and preventive action plans.

• Mentor and train new staff while conducting Monitoring Evaluation Visits.

• Oversee the contracting or invoicing of local clinical vendors.

• Develop and update Standard Operating Procedures (SOPs) in line with Good Clinical Practices and regulatory standards.

• Participate in bid defense meetings and contribute to company process improvement initiatives.

• Conduct monitoring activities as required based on project needs.

⛳️ Requirements

• Bachelor's degree or RN degree in a life science or related field, or equivalent education and experience.

• At least 6 years of clinical research experience across multiple studies and countries.

• Experience in managing the clinical aspects of studies in more than one region or comparable study complexities.

• Ability to effectively mentor and train other Clinical Trial Managers (CTMs) and CRAs in a positive manner.

• Extensive knowledge of clinical trials and the key components that contribute to their success.

• Expertise and skills in diverse therapeutic areas.

🏝️ Benefits

• Collaborative, international team environment.

• Opportunities for career advancement.

• Flexible work environment.

• Work-life balance.

• A passionate and cooperative team of experts.

• The chance to help deliver safe and effective pharmaceutical treatments to patients globally.