.**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- Coordinates study/protocol training and Investigator Meetings- 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
