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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

• 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]

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 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

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

• 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

Subject Matter Expertise

• 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

Skills:

• 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

• 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:

• 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

Education:

• 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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