Study Operations Manager – Clinical Trial Manager
Parexel
full-time
Posted on:
Location Type: Remote
Location: United States
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About the role
- 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.
Requirements
- 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
Benefits
- 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
operational clinical trial experiencestudy startup process managementbudget managementrisk managementquality planningsubmission strategy developmentdeviation managementmitigation strategy implementation
Soft Skills
leadershipstrategic planningorganizational skillscollaborationcommunication