Global Study Manager II
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Job Description
Global Study Manager II at Parexel coordinating global clinical trial execution and ensuring compliance. Leading operational strategy and vendor management for successful clinical trials.
Responsibilities:
- Leads and coordinates the execution of a clinical trial globally
- Provides quality oversight and coordination of regional and country operations
- Provides leadership to the teams in setting recruitment targets and delivery milestones
- Serves as a critical member of the core team and represents the operational sub-team
- Drives decision making and works closely with the Clinical Study Team Lead to provide input to operational strategy
- Ensures development of study level plans
- Approves and oversees drug supply management
- Ensures overall vendor oversight for vendors managed by SOMs
- Reviews consolidated pre-trial assessment reports and feasibility outputs
- Coordinates development of study and protocol training
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
- Experience in clinical research and/or study management
- Study management/leadership experience
- Experience with oversight of CROs and vendors
- Experience in managing per subject costs, vendor and ancillary and monitoring costs projections and spend
- Ability to work outside of core business hours, as required, to support global trials or initiatives
- Ability to travel, as required, including IMs, vendor kick off and re-set meetings, and client internal global or department level meetings
- Fluency in written and spoken English required.
Benefits:
- N/A
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