Global Study Manager United Kingdom

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.

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

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

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

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

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

Provides supervision and/or mentorship to SOMs and possibly other 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 SOMs (if assigned) or to Clinical Study Team Assistants (CSTAs) as appropriate

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

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

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

Ensures applicable system closure at study completion

May support study level submission readiness

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

Accountable for study management and oversight of all study management functions

Forms, oversees, and leads the operational sub team and requests resources as needed

Ensures the development of realistic detailed study startup and/or study management strategies and monitoring plans, including sourcing strategy, input into requests for proposals, and for the selection of vendors

Ensures country level feasibility is completed in collaboration with cross functional departmental colleagues, organizations, and pCRO, reviewing PTA report outputs,…