Responsibilities for study and regional or specific country level activities from study startup through conduct and study close on one or more studies
Provides leadership, strategic planning, and organization skills to ensure the operational delivery of tasks
Serves as leader of the local study team on one or more studies
Provides back up to or assumes the responsibilities of the GSM as needed
Oversees the preferred Contract Research Organization and/or Country Trial Manager/Site Care Partner for assigned studies at country level
Manages and maintains accurate country level plans (e.g., timelines, budget, risk, and quality plans)
Manages the study startup process in countries assigned or oversees the CRO responsible for these activities
Liaises with SCP, Lead SCP, Site Activation Partners and regulatory colleagues in country to agree on submission strategy to Health Authorities and Ethics Committees
Provides country level input on startup and recruitment milestones during planning
Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution and implements mitigation strategies as required.

Bachelor’s of Science or Bachelor’s of Arts degree with a minimum 5 years of relevant operational clinical trial experience required
Master’s of Science or Master’s of Business Administration degree with a minimum 3 years of relevant operational clinical trial experience required
A scientific or technical degree is preferred

EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Study Operations Manager – Clinical Trial Manager

Key skills