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 escalate 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, 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, pCRO]
Accountable for the delivery of the study against approved plans
Works directly with cross-functional and department lines and pCRO 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, pCRO)
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 pCRO 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
Requires exceptional knowledge of own discipline and advanced knowledge of others and applies these skills to ensure a sub-business unit/sub-operating unit meets its goals
Creates an environment where innovation is standard, taking appropriate risks to advance innovative processes
Develops ideas and leads complex projects across sub-business unit/sub-operating unit
Develops innovative solutions to complex problems impacting a sub-business unit/sub-operating unit
Exercises own judgment and is a resource for others
Acts independently on self-initiated projects
Experience in clinical research and/or study management
Study management/leadership experience
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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
