Country Study Operations Manager I
Parexel
full-time
Posted on:
Location Type: Remote
Location: Turkey
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About the role
- Supports Global Study Managers (GSMs), other SOMs, and the larger study management delivery of the study by leading specific parts of the project, driving specific countries, executing tasks of moderate complexity, and developing solutions to problems as needed to support deliverables
- Serves as leader of the local study team (core members, ad hoc members, and other key stakeholders as required) on one or more studies
- Oversees the preferred Contract Research Organization (pCRO) and/or Country Trial Manager (CTM)/Site Care Partner (SCP) for assigned studies at country level in accordance with the overall project plan, and 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 [where the Start Up Project Manager (SUPM) is not assigned] and/or oversee the pCRO responsible for these activities as applicable
- Liaises with SCP, Lead SCP, Site Activation Partners (SAPs), and regulatory colleagues in country to agree on submission strategy to Health Authorities (HAs) and Ethic Committees (ECs)
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
- Comprehensive knowledge in managing and coordinating specific tasks and responsibilities as part of a larger study management team
- Comprehensive knowledge of own discipline with good knowledge of other disciplines to ensure that the study can meet its goals and to serve as a resource for others
- Demonstrated clinical research experience and/or study management/startup project manager experience
- Demonstrated experience in managing country level operational activities and/or vendors
- Ability to work outside of core business hours, as required, to support global trials or initiatives
Benefits
- Health insurance
- Professional development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical trial managementstudy managementproject managementoperational activities managementvendor managementsubmission strategyrisk managementbudget managementtimelines managementproblem-solving
Soft Skills
leadershipcommunicationcollaborationorganizational skillsinterpersonal skillsadaptabilityteamworkresourcefulnessattention to detailtime management
Certifications
Bachelor’s degreeMaster’s degree