Global Study Manager - 6-month contract - FSP

When our values align, there's no limit to what we can achieve.

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.
About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose - moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry leading innovation, With Heart.
Key Accountabilities:
Study Management Oversight
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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

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Provides quality oversight and coordination of regional and country operations and the pCRO for the tasks both owned by and delegated to Study Operational Managers (SOMs), if assigned to study, related to study execution

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Provides leadership to the teams in setting recruitment targets and delivery milestones as the single point of accountability for detailed study start up, monitoring, and other study level plans and delivery to the agreed plans by partnering with cross functional colleagues

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Serves as a critical member of the core team and represents the operational sub-team including applicable vendors and pCRO on matters of study execution

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Drives decision making and works closely with the Clinical Study Team Lead (CSTL) to provide input to operational strategy

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Provides supervision and/or mentorship to SOMs and possibly other GSMs

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Ensures development of study level plans, including the study monitoring and study training plans

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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 SOMs (if assigned) or to Clinical Study Team Assistants (CSTAs) as appropriate

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Approves and oversees drug supply management, manages flow of drug supply to the sites, and sets up interactive randomization systems with supply chain lead

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Ensures overall vendor oversight for vendors managed by SOMs (if assigned), action escalations related to vendor issues and escalate further as necessary

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Reviews consolidated pre-trial assessment (PTA) reports and feasibility outputs in partnership with appropriate cross functional colleagues

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Ensures applicable system closure at study completion

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May support study level submission readiness

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May participate in vendor user accountability testing (UAT) and system setup requirements review and approval [e.g., Interactive Response Technology (IRT), central lab]

Study Management Operations
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Accountable for study management and oversight of all study management functions

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Forms, oversees, and leads the operational sub te