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Senior Study Associate
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Join to apply for the Senior Study Associate role at Daiichi Sankyo US Overview Assist in planning and execution of clinical studies, under the supervision of the Study Manager and the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), FDA regulations/EU Directive, and ICH guidelines. The key focus is on providing clinical trial management support to study teams and tracking CRO and other vendor performance against project goals and milestones to monitor and ensure compliance with the Daiichi Sankyo Clinical Study Oversight Plan (CSOP). Responsibilities Reconcile the TMF document trackers generated by the CRO with the document archive. Bring issues with the reconciliation to the attention of the Study Manager and propose remediation plan. Distribute key study documents to the CRO and vendors as appropriate. Provide clinical administrative support to the study teams. This may include preparing meeting logistics, distributing agendas, and minutes for study team meetings, meetings with Academic Research Organizations (AROs), and meetings with CRO and Investigator Meetings. Support Fair Market Value process in evaluating study budgets. Collect information and coordinate with DS Regulatory Operations to post trial information on required public forums (e.g. clinicaltrials.gov). Under supervision, review and document CRO-generated reports, such as site monitoring trip reports and protocol deviation reports and elevate issues to the attention of the supervisor. Compile and maintain a monitoring review spreadsheet and CRO Oversight Monitoring (CROOM) visit output. Analyze study site metrics reports to identify potential areas of concern and bring to supervisors attention. Track study metrics such as site start-up, Investigator/site performance, recruitment, regulatory documents, TMF filing and QC activities and elevate areas of concern to your supervisor. Create/maintain spreadsheets to track other items as needed (e.g., Vendor invoices). Work with Insurance Brokers to obtain study site Insurance and provide tracking and oversight to the Vendor handling lab logistics and any other vendors deemed appropriate. Participate in training; make recommendations for areas of improvement and innovation (study, or departmental level). Work with supervisor to provide input into individual career development plan. Qualifications Bachelor's Degree (preferred in Life Sciences) with relevant clinical development experience required; 2 or more years work experience with Bachelors degree required. Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO) or Contract Research Organization (CRO). CRA experience preferred. Time spent directly in a medical environment (e.g. as a Study Site Coordinator) is also considered relevant. Travel Ability to travel up to 5%. In-house office position that may require occasional travel. Equal Opportunity Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range $99,120.00 - $148,680.00 #J-18808-Ljbffr
