Clinical Research Associate Manager

This is a fully remote position, open to applicants in United States, +2 more locations.

📋 Description

• Oversee a team of 6–14 Clinical Research Associates to guarantee outstanding study and site performance.

• Ensure compliance with local regulations, company SOPs, and ICH GCP guidelines.

• Foster talent development through training, support, and mentoring initiatives.

• Address low or non-performance situations and manage CRA escalations effectively.

• Collaborate at the country level with Clinical Research Managers and other stakeholders to enhance country capabilities.

• Work in partnership with Line Managers across monitoring functions.

• Assist in HQ capacity and resource planning, ensuring efficient resource allocation.

• Distribute work, nurture staff growth, and carry out performance evaluations.

• Support departmental initiatives and workstreams within the organization.

• Report on current manpower while forecasting CRA capacity and requirements.

• Maintain process consistency and protocol implementation throughout the country.

• Engage with sites to address operational issues in coordination with the study CRM.

• Participate in local Investigator Meetings when required.

• Collaborate with GCTO partners on clinical trial execution.

• Raise site performance concerns to the Head of Site Management and Monitoring.

• Coordinate with local HR and finance departments.

• Ensure CRA adherence to corporate policies, procedures, and quality standards.

• Primarily focus on Vaccine/Infectious Disease trials, with additional work in the Cardiovascular therapeutic area.

⛳️ Requirements

• Bachelor’s degree in a Science-related field.

• At least 5 years of experience in Clinical Research.

• Minimum of 3 years’ experience as a CRA monitoring clinical trials.

• Line management experience is preferred, or at least experience in a team leader role.

• Capability to work autonomously as well as collaboratively within a team setting.

• Exceptional people management, time management, project management, and organizational abilities.

• Proven history of strong performance outcomes.

• Skills and judgment necessary to act as a responsible steward and decision-maker for the company.

• Fluency in the Local Language and business proficiency in English, both verbal and written.

• Strong understanding of applicable ICH/GCP regulations and Good Documentation Practices.

• Proficient in core trial management systems and tools.

• High emotional intelligence.

• Demonstrated strong leadership abilities with a track record of success in people management.

• Excellent interpersonal and communication skills, along with conflict resolution capabilities.

• Ability to establish relationships and communicate effectively with external customers, including sites and investigators.

• Strong influencing skills.

• Available to US and Puerto Rico residents only.

• No visa sponsorship is available.

• Willingness to travel 50% of the time.

🏝️ Benefits

• Annual bonus and long-term incentives, if applicable.

• Comprehensive medical, dental, vision healthcare, and other insurance benefits for employees and their families.

• Retirement benefits, including 401(k) plans.

• Paid holidays.

• Vacation time.

• Compassionate and sick days.

• Flexible remote work arrangements.

• No relocation is required.