When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. The Study Operations Manager II (SOM II) has responsibilities for study and regional or specific country level activities from study start-up through conduct and study close on one or more studies, providing 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 (CRO) and/or Country Trial Manager (CTM)/Site Care Partner (SCP) for assigned studies at country level in accordance with the overall project plan Manages and maintains accurate country level plans (e.g., timelines, budget, risk, and quality plans) May manage the study start up process in countries assigned Liaises with site activation and regulatory colleagues in country to agree on submission strategy to Health Authorities (HAs) and Ethics Committees (ECs) Provides country level input on start-up and recruitment milestones Collaborates with accountable roles to identify and manage deviations and risks in study start-up and execution and implements mitigation strategies as required. Requirements: Bachelor’s of Science or Bachelor’s of Arts degree with a minimum 7 years of relevant operational clinical trial experience required Master’s of Science or Master’s of Business Administration degree with a minimum 6 years of relevant operational clinical trial experience required 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. Headquartered near Boston, Massachusetts and in Durham, North Carolina, Parexel has over 16,000 employees, with offices that support clients in over 100 countries around the world. We provide the most comprehensive drug development capabilities of any CRO worldwide. Our global regulatory expertise, Phase I-IV clinical research services, and advanced commercialization services all work together to move you through the development journey more smoothly and cost-effectively from beginning to end.