Global Study Manager​/Project Leader - US or Canada - FSP

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 (CRO), 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 CRO 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 CRO 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]

Study Management Operations

• 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 CRO, reviewing PTA report outputs, approving sites, and assessing site activation plans

• Ensures Trial Master File (TMF) setup for study management and country and site level documents

• Provides input into the risk planning process for the study

• Coordinates development of study and protocol training and global investigator meetings (IMs)

• Ensures that local IMs are coordinated by the SOM, if assigned to study

• Develops and provides key inputs to clinical trial budget (e.g., per subject costs)

• Ensures that…