Contribute to the development and review of region specific

RESPONSIBILITIES Study Planning Management Responsible for regional study planning activities as agreed and delegated by the Study Lead, such as: Participate with Study Lead on regional study feasibility assessment activities (if applicable) Ensure timely development and finalization of region specific sections of study plans and manuals as per the study team / project team charter. Contribute to the development and review of region specific elements of critical study documents, such as study protocol Knockoff Hermes Bag, eCRF, ICF template Replica Hermes Birkin, and others Identify regional CLO risks and mitigations and share with the Study Lead Identify, resolve or, if necessary, escalate regional CLO issues that have a significant impact to overall global CLO study timelines, other functions, budget or quality to the Study Lead as per study team / project team charter Lead CLO regional study activity timeline development and contribute to regional study budget development and management Provide regional/local operational and regulation knowledge to Study Lead as related to the study(ies) in support of enrollment strategies Provide regional study status updates to Study Lead Vendor Management Contribute to regional vendor evaluation and selection process Oversee day to day regional CRO and vendors’ contracted activities as per regional oversight plans Work with COA to ensure final payments to regional vendors at study closure Study Conduct Responsible for all region specific study conduct activities, including: Start up: Lead site identification, qualification, selection and activation activities for the study, such as site and staff training Replica Hermes Birkin, site budgets, site or country specific ICF and site investigator contracts Plan and deliver IM in collaboration with other key stakeholders Enrollment and Maintenance: Ensure adherence to study enrollment strategy and plan Ensure adherence to monitoring plan Ensure adherence to monitoring oversight SOP Ensure timely site payments Partner with Patient Advocacy to manage patient travel, housing and associated patient management costs as applicable for the study Closure: Oversee all study closure activities (sites Replica Hermes, reconciliation activities, filing archiving, and e/TMF related activities) Coordinate and oversee data listing reviews Ensure timely uploading of clinical documents for the CSR appendices Cross functional Representation Support Study Lead on any delegated cross functional activities Additional Train and mentor junior regional team members such as CRAs and CTAs Prepare regional standard metrics (KPIs, SQMs) for global study dashboards to routinely monitor team activities and ensure compliance to timelines, quality and budget Provide forecast for regional clinical supply Replica Hermes Birkin Bag, including ancillary supplies and comparator drugs Ensure compliance with regional regulations, GCP, and SOPs during the execution of the study Contribute expertise to departmental and cross functional process improvement activitiesEDUCATION / EXPERIENCE: BA/BS or higher in nursing, life or health sciences is preferred. 7 10 years of relevant pharmaceutical /biotech industry experience bio Location: This position is based in San Rafael, California at BioMarin’s corporate headquarters.

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