Sr Clinical Study Assoc CO

Sr Clinical Study Assoc CO Employer Daiichi Sankyo Location Basking Ridge - NJ Start date May 4, 2026 View more categories View less categories Discipline Clinical , Clinical Research Required Education Bachelors Degree Position Type Full time Hotbed Pharm Country , Best Places to Work Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Send job

Job Details Company Job Details Job Description Job Title:

Sr Clinical Study Assoc CO Job Requisition ID:

1454

Posting Start Date:

5/4/26 At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary Assist in planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. 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 Daiichi Sankyo Clinical Study Oversight Plan (CSOP). Job Description 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 meeting, 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 (eg.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. Compile and maintain CRO Oversight Monitoring (CROOM) visit output Analyze study site metrics reports to identify potential areas of concern and bring to supervisor's 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). Works with Insurance Brokers to obtain study site Insurance 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. Responsibilities Continued Qualifications Education Qualifications Bachelor's Degree (preferred in Life Sciences) with relevant clinical development experience required Experience Qualifications 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. preferred Travel Requirements Ability to travel up to 5% of the time. In-house office position that may require occasional travel. Additional Information 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 - USD$151,440.00 Download Our Benefits Summary PDF Professionals Company Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. For more information, please visit: www.daiichisankyo.com . Daiichi Sankyo, Inc., headquartered in Basking Ridge, New Jersey, is a member of the Daiichi Sankyo Group. To learn more about Daiichi Sankyo, Inc., please visit www.dsi.com .

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4568 Company info Website http://www.daiichisankyo.com/ Phone (908) 992-6400 Location 211 Mt. Airy Road Basking Ridge New Jersey 07920 United States Share this job Facebook Twitter LinkedIn Apply now Send job Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Get job alerts Create a job alert and receive personalized job recommendations straight to your inbox. Create alert