Senior Study Manager - FSP

*******US- Remote- All locations*****

Dedicated

Senior Study Manager

Position Purpose:

• The Senior Study Manager (SSM) has responsibility for one or more studies of moderate complexity generally with responsibility for all study management aspects of assigned studies
• The SSM leads and manages the tactical execution of one or more clinical studies from study startup through database release and inspection readiness to ensure timely delivery of quality study data.
• The SSM provides quality oversight to the Contract Research Organization (CRO) and of the CRO deliverables related to study execution
• The SSM may also input to and support compilation of sections to Clinical Study Reports
• The SSM will provide leadership to the teams in the setting of realistic recruitment targets and delivery milestones as the single point of accountability for detailed study start-up and monitoring plans and for delivery to the agreed plans
• The SSM is a core member of the Study Team and will represent the CRO on matters of study execution
• The SSM works with functional lines and directly with CRO line functions to resolve or triage site level issues
• The SSM will drive decision making and work closely with the Clinical Study Team Lead (CSTL) to provide input to operational strategy
• For studies where more than one SSM is assigned, may be required to act as ‘lead’ SSM and will coordinate activities of the other SSMs assigned

Organizational Relationships:

• Reports to the Parexel FSP assigned Line Management with day-to-day direction from Client. Refer to Organizational Chart for details regarding assigned role and associated reporting structure
• In addition to responsibilities for working with other SMs, the SSM will be responsible for liaising with members of the project team and other cross functional lines as required for technical system and process expertise and Therapeutic Area (TA) operational knowledge

Primary Duties:

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

• May expand study design document into approved protocol template while incorporating input from other team members (e.g., Clinician, Clinical Pharmacology Lead, Supply Chain (SC) 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 Supply Chain Lead
• Reviews consolidated Pre-trial assessment reports, feasibility outputs, etc.
• May support study level submission readinessStudy 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

o  Works proactively with CRO and data management functions to ensure alignment on data flow and timely delivery

• Shares and escalates plan deviations to CSTL (and study team)
• Provides ongoing assessment of subject enrollment/discontinuations to inform accurate forecasting for financial planning
• Provides operational input into protocol designSubject 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, can serve as a resource to the study team to facilitate

the audit/inspection

General

• Completes training assigned by Client and/or Parexel FSP as necessary, including general training requirements, SOPs, system, and process related training
• Adheres to EP and Client SOPs and processes

Skills and Education:

• BS/Nurse – minimum of 5 years relevant experience
• MS/PhD – minimum of 3 years relevant experience
• Extensive global clinical trial/study management experience
• Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations
• Demonstrated study management/leadership experience
• Demonstrated oversight of CROs
• Demonstrated experience in managing per subject costs, vendor and ancillary, and monitoring costs projections and spend
• Understands how to work with vendors to accomplish tasks
• Ability to interpret study level data and translate and identify risks