Sr Clinical Study Assoc CO

Job Summary Assist in planning and execution of clinical studies under the supervision of the Study Manager. Ensure adherence to protocol, GCP, SOPs, FDA regulations, EU Directive, and ICH guidelines. Key focus is providing clinical trial management support, tracking vendor performance, and ensuring compliance with Daiichi Sankyo CSOP. Responsibilities Reconcile the TMF document trackers generated by the CRO with the document archive, bring issues to Study Manager, and propose remediation plans. Distribute key study documents to the CRO and vendors as appropriate. Provide clinical administrative support to study teams, including meeting logistics, agendas, and minutes for team meetings, ARO interactions, and CRO/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 supervisor. Compile and maintain a monitoring review spreadsheet. Compile and maintain CRO Oversight Monitoring (CROOM) visit output. Analyze study site metrics reports to identify potential concerns and bring them to supervisor’s attention. Track study metrics including site start-up, investigator/site performance, recruitment, regulatory documents, TMF filing, QC activities, and elevate concerns to supervisor. Create and maintain spreadsheets to track other items as needed (e.g., vendor invoices). Work with insurance brokers to obtain study site insurance. Provide tracking and oversight to vendor handling lab logistics and other appropriate vendors. Participate in training, recommend areas of improvement and innovation, and work with supervisor to develop individual career development plans. Qualifications Education Qualifications Bachelor's Degree (preferred in Life Sciences) with relevant clinical development experience required. Experience Qualifications 2 or more years of work experience with a Bachelor’s degree required. Experience considered relevant includes clinical or basic research in a pharmaceutical company, 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 Requirements Ability to travel up to 5% of the time. 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

USD $100,960.00 – $151,440.00

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