The Global Study Manager II (GSM II) provides operational leadership throughout the study lifecycle, with accountability for oversight and execution of study management, site management, preferred Contract Research Organization (pCRO), and vendor deliverables for all study management deliverables in a study.
Key Accountabilities:
Study Management Oversight
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
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
Study Management Operations
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, approving sites, and assessing site activation plans
Ensures that SOMs are inputting into the budget for local/country level tasks (if assigned), and reviews cost variance, invoices, and purchase orders (POs) in a timely manner to ensure that spend is appropriate and on track with the forecast
Monitors the budget and contracts for assigned vendors [e.g., central labs, electronic patient reported outcomes (ePRO), radiology, pCRO]
Monitors vendor contracts for out of scope activities and budget spend and invoices for assigned vendors (e.g., central labs, ePRO, radiology)
Study Team Interface
Leads and oversees all elements of study startup and monitoring functions to ensure delivery and compliance with all applicable Standard Operating Procedures (SOPs) and quality standards, interfacing directly with CRO feasibility and study startup, monitoring and management, and site contracting groups
Review vendor expenses and workorders as per study budget for assigned vendors (e.g., central labs, ePRO, radiology, pCRO)
Subject Matter Expertise
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
Provides technical oversight of the operational sub team to include but is not limited to standards, continuous improvement, issue escalation and resolution, inspection readiness and quality assurance, performance feedback, review of metrics
Skills:
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 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
Knowledge and Experience:
Education:
#LI-LO1
#LI-REMOTE
