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Clinical Study Associate
2 months ago
Join a Legacy of Innovation 110 Years and Counting
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 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. 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.
Responsibilities:
Reconcile the TMF document trackers generated by the DS TMF team and/or CRO with the document archive. Bring issues with the reconciliation to the attention of the supervisor. Distribute key study documents to the CRO and vendors as appropriate.Upload DS country and study level documents to the TMFConfirm Essential Document Listing accuracy throughout duration of trialProvide clinical administrative support to the study teams. This may include preparing meeting logistics, distributing agendas, and preparing minutes for study team meeting, meetings with Academic Research Organizations (AROs), and meetings with CRO and Investigator Meetings.Collect information and coordinate with DS Regulatory Operations to post trial information on required public forums ).Grant access to study systems for internal DS study team members and applicable CRO study team members.Works with Insurance Brokers to obtain study site InsuranceProvide tracking and oversight to the vendor handling lab logistics and any other vendors deemed appropriate.Under supervision, 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 the supervisor.Create/maintain spreadsheets to track other items as needed, (e.g. Vendor invoices).Participate in training and departmental objectives. Work with supervisor to provide input into individual career development plan.Assist in planning and execution of clinical studies, under the close supervision of a Manager (or above) 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 administrative support to study teams and tracking Contract Research Organizations (CROs) and other vendors performance against project goals and milestones to ensure compliance with Daiichi Sankyo Clinical Oversight Plan (CSOP)Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education Qualifications: (from an accredited college or university)Bachelor's Degree (preferred in Life Sciences) with relevant clinical development experience requiredExperience Qualifications:1 or More Years relevant experience.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:Ability to travel up to 5% In-house office position that may require occasional travel.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.