Country Study Operations Manager – Clinical Trial Manager

Job Description

As a Country Study Operations Manager at Parexel, you'll be pivotal in the operational success of clinical trials. This role involves overseeing activities from study initiation to completion at the country or regional level. You'll support Global Study Managers and local teams, ensuring seamless execution and adherence to clinical protocols. Your responsibilities include managing Contract Research Organizations and Country Trial Managers, and collaborating with regulatory teams to develop effective submission strategies for Health Authorities and Ethics Committees. Furthermore, you will play a crucial role in identifying and mitigating deviations and risks during study startup and execution, contributing to the overall efficiency and success of clinical trials.

Qualifications

1. A minimum of 3-5 years of clinical trial study management experience is essential for this role. 2. Comprehensive knowledge of Good Clinical Practice (GCP) and clinical and regulatory operations is necessary. 3. Candidates must demonstrate clinical research experience and/or project management/startup experience. 4. A Bachelor's degree in Science or Arts, coupled with at least 7 years of relevant operational clinical trial experience, is required. Alternatively, a Master's degree in Science or Business Administration with a minimum of 6 years of relevant experience will also be considered. 5. Fluency in both written and spoken English is a mandatory requirement for this position.

Benefits

- Health insurance coverage. - 401(k) retirement plan options. - Generous paid time off for work-life balance. - Flexible work arrangements to accommodate personal needs. - Opportunities for professional development and career advancement.