Global Study Manager/Global Trial Manager - Remote - FSP

When our values align, there's no limit to what we can achieve. Â 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. Parexel is actively recruiting for an experienced Global Trial Manager/Study Manager to join us in Europe As the Global Study Manager, you will provide operational leadership throughout the study lifecycle, with accountability for oversight and execution of study management, site management, preferred Contract Research Organization, and vendor deliverables for all study management deliverables in a study. Some specifics about this advertised role

• Leads and coordinates the execution of a clinical trial globally from sourcing strategy and study specification development for requests for proposals to fully outsourced studies and ancillary vendors, study start up through database release and inspection readiness to ensure timely delivery of quality study data. May also provide input to and support compilation of sections to clinical study reports (CSRs) as needed.
• Drives decision making and works closely with the Clinical Study Team to provide input to operational strategy
• Provides supervision and/or mentorship to country trial managers and possibly other junior GSMs.
• Ensures development of study level plans, including the study monitoring and study training plans.
• Develops, reviews, or approves the study startup, study monitoring, protocol recruitment, and training plans and other documents, guidelines, and plans.
• May delegate development of plans or components of plans to junior trial team members
• Support results/documents disclosure of global registries.
• Champions the implementation and use of harmonized, consistent processes, and excellence in study management deliverables related to cost and effective, timely, and high quality clinical trial data according to agreed global goals.

Who are Parexel Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base. We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients. What we are looking for in this role For every role, we look for professionals who have the determination and courage always to put patient well-being first. That to us is working with heart. Here are a few requirements specific to this advertised role.

• Bachelor’s of Science or Bachelor’s of Arts degree with a minimum 7 years of relevant operational clinical trial experience or Master’s of Science or Master’s of Business Administration degree with a minimum 6 years of relevant operational clinical trial experience required
• Experience with oversight of CROs and vendors
• Experience in managing per subject costs, vendor and ancillary and monitoring costs projections and spend
• Fluency in written and spoken English required
• 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

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