Study Senior Manager (SSM)

Operational Study Management for one or more studies of moderate complexity generally with responsibility for all study management aspects of assigned studies. Accountable for the development of realistic detailed study start-up and monitoring plans Accountable for conducting country level feasibility in collaboration with Global Clinical Trial Execution and CROs, reviewing Pre-trial Assessment outputs, approving sites, and assessing site activation plans Leads study risk planning process in context of site and subject Coordinates study/protocol training and Investigator Meetings Develops and provides key inputs to Clinical Trial Budget (e.g., per subject costs) Accountable for the delivery of the study against approved plans Leads inspection readiness activities related to study management and site readiness May produce or review model Informed Consent Document (ICD) and study/country/site level ICD, as appropriate M ay expand study design document into approved protocol template while incorporating input from other team members (e.g., Clinician, Clinical Pharmacology Lead, SCC Lead, Statistician, Outcomes Research Representative, Clinical Assay Group, etc.) Study Management Oversight Approves the Study Start-up, Study Monitoring and protocol Recruitment Plans Approves and oversees drug supply management Manages flow of drug supply to the sites and set-up Interactive Voice Randomization System (IVRS) with SCC Lead Reviews consolidated Pre-trial assessment reports, feasibility outputs, etc. May support study level submission readiness

Study Team Interface Leads and oversees all elements of study start-up and monitoring functions both internally and at the CROs to ensure delivery and compliance with all applicable Standard Operating Procedures (SOPs) and Quality Standards. Interfaces directly with CRO to determine Feasibility/Study Start-up, Monitoring/Management, and Site Contracting Groups Works proactively with CRO and data management functions to ensure alignment on data flow and timely delivery Shares and escalates plan deviations to CPM and study team Provides ongoing assessment of subject enrollment/discontinuations to inform accurate forecasting for financial planning Provides operational input into protocol design

Subject Matter Expertise Serves as the 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-effective, timely, and high-quality clinical trial data according to agreed global goals Responsible for the technical oversight of the CRO to include, but not limited to: mentoring, standards, continuous improvement, issue escalation/resolution, inspection readiness/quality assurance, performance feedback, review of metrics Partners with CRO Managers to proactively identify and resolve study operations staff performance issues For project-specific audits and inspections, the SSM can serve as a resource to the study team to facilitate the audit/inspection

General Completes training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, system, and process related training Adheres to EP and Client SOPs and processes QualificationsTraining and Education: Extensive global clinical trial/study management experience Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations BS/Nurse – minimum of 5 years’ relevant experience MS/PhD – minimum of 3 years’ relevant experience Demonstrated study management/leadership experience Demonstrated oversight of CROs Demonstrated experience in managing per subject costs, vendor, ancillary, and monitoring costs projections and spend Understands how to work with vendors to accomplish tasks Ability to interpret study level data, translate and identify risks A bility to proactively identify and mitigate risks around site level in study execution Understands feasibility of protocol implementation Country level cultural awareness and strong interpersonal skills Keen problem solving skills Excellent communication skills, both written and verbal Must be fluent in English Detail oriented and possesses technical expertise (e.g., spreadsheets, metrics, and data flow management)