Clinical Site Manager (CRA) Midwest - Indianapolis, Cincinnati, Louisville

Clinical Site Manager (CRA) Midwest - Indianapolis, Cincinnati, Louisville About Astellas Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com. Are you driven to make a real difference in the lives of patients? We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact. Purpose & Scope A Clinical Site Manager (CSM) serves as the primary contact point between the Sponsor and the Investigational Site. A CSM is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure. The Site Manager will manage the site/sponsor relationship as it relates to clinical trial delivery through consistent communication and support. The Site Manager will partner with Clinical Trial Lead (CTL,) Clinical Trial Manager (CTM,) Clinical Trial Specialist (CTS,) and Study Start-Up Specialist (SSS) to ensure overall site management while performing trial related activities for assigned protocols. Responsibilities may include assisting with or primary responsibility for:

• Site Selection
• Pre-trial assessment
• Site level Study Participant recruitment/retention plans
• Site Activation/Initiation
• On-site and remote monitoring
• Overall site relationship management in collaboration with other sponsor roles that interact with the site
• Close-out activities

Reports to the regional Site Management Lead Early or Late-Stage Site Monitoring & Management Organization. This position may provide mentoring to less experienced site managers and may provide oversight for contract team members. A matrix relationship to the study teams is essential in effective execution of this role. Role and Responsibilities

• Acts as primary local company contact for assigned sites for specific trials. Trials may include both early and late phase clinical trials.
• Develops meaningful site relationships through consistent collaborative communication and engagement.
• May participate in site feasibility and/or pre-trial site assessment visits.
• Attends/participates in investigator meetings as needed.
• May serve as Lead CSM for specific study providing study level oversight and support for CSMs assigned to the study. This assignment ensure study level information is shared with assigned CSMs and has key role in establishing site monitoring strategy for study.
• Responsible for driving activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. Responsible for the implementation of risk-based monitoring approaches at the site level and to work with site to ensure timely resolution of issues found during monitoring visits.
• Ensures site staff are trained, and the corresponding training records are complete and accurate at any time point during all trial phases. Responsible in close collaboration with study team for the activities during site activation phase to speed up the process and activate the site in the shortest possible timeframe.
• Ensure site compliance with study protocol, ICH-GCP, and local/country regulations.
• Ensure ongoing adequacy of site (facilities, staff) for trial conduct.
• Ensure source and other site documentation is adequate and in compliance with ALCOA-CCEA.
• Involved with site level recruitment strategy and prioritization and implementation in partnership with other functional areas.
• Ensures site non-IMP study supplies are adequate for trial conduct.
• Ensures that clinical drug supplies are appropriately used, handled, and stored and returns are accurately inventoried and detailed.
• Oversees the appropriate destruction of clinical supplies.
• Ensures site staff complete data entry and resolve queries within expected timelines.
• Ensures validity and completeness of data collected at trial sites.
• Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs) are reported w

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