Global Study Manager - FSP

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 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, CRO]

Accountable for the delivery of the study against approved plans

Works directly with cross-functional and department lines and CRO to resolve or triage site level issues

Leads inspection readiness activities related to study management and site readiness

Supports development and delivery of decentralized capabilities at investigator sites

Ensures timely study closure and release of internal and external resources as appropriate if assigned to study post database lock

Monitors vendor contracts for out of scope activities and budget spend and invoices for assigned vendors (e.g., central labs, ePRO, radiology)

Reviews study level metrics and analytics and ensures appropriate actions are taken to mitigate risks and resolve issues

Works independently and demonstrates resourcefulness

May, on occasion, take on the role and responsibilities of a SOM

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

Works proactively with data management functions and department colleagues to ensure alignment on data flow and timely delivery

Regularly reviews data reports and dashboards to identify risks and drive appropriate actions

Shares and escalates plan deviations to CSTL and study team and drives and oversees mitigations

Review vendor expenses and workorders as per study budget for assigned vendors (e.g., central labs, ePRO, radiology, CRO)

Provides ongoing assessment of subject enrollment and discontinuations to inform accurate forecasting for financial planning

Provides operational input into protocol design

Leads protocol deviation trend review, partnering with the clinical team

May lead and facilitate the routine study management vendor calls

Serves as technical expert for study management systems and processes

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

Partners with the operational sub team and CRO to proactively identify and resolve study operations staff performance issues

May serve as a resource to the study team in addition to the SOM(s), if assigned, to facilitate project specific audits and inspections

Exceptional knowledge of study management processes and deliverables

Good knowledge in understanding the responsibilities beyond their function to ensure goals are met for the study

Maintains expertise within the assigned therapeutic area and study to set the appropriate strategy, identify risks and to drive operational deliverables

Working knowledge of Good Clinical Practices (GCPs), monitoring, clinical and regulatory operations

Bachelor’s of Science or Bachelor’s of Arts degree with a minimum 7 years of relevant operational clinical trial experience required

Master’s of Science or Master’s of Business Administration degree with a minimum 6 years of relevant operational clinical trial experience required

A scientific or technical degree is preferred along with extensive knowledge of clinical trial methodology

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