Sr Clinical Study Assoc CO

Job Summary

Assist in planning and execution of clinical studies, under the supervision of the Study Manager, within Clinical Operations, adhering to protocols, GCPs, SOPs, FDA regulations/EU Directive, and ICH guidelines. Focus on providing clinical trial management support to study teams and ensuring compliance with 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 plans.
• Distribute key study documents to the CRO and vendors as appropriate.
• Provide clinical administrative support to the study teams, including preparing meeting logistics, distributing agendas, and minutes for study team meetings, ARO meetings, and investigator meetings.
• Support Fair Market Value process in evaluating study budgets.
• Collect and post trial information on required public forums (e.g., clinicaltrials.gov).
• Review and document CRO-generated reports, such as site monitoring trip reports and protocol deviation reports, and escalate issues to the supervisor.
• Create and maintain monitoring review spreadsheets.
• Compile and maintain CRO Oversight Monitoring (CROOM) visit outputs.
• Analyze study site metrics reports to identify potential areas of concern and bring them to the supervisor's attention.
• Track study metrics such as site start-up, investigator/site performance, recruitment, regulatory documents, TMF filing, and QC activities, and escalate 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.
• Track and oversee vendor handling of lab logistics and other vendors as deemed necessary.
• 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 plans.

Qualifications

• Education: Bachelor's Degree (preferred in Life Sciences) with relevant clinical development experience required.
• Experience: 2 or more years work experience with a Bachelor's degree required. Relevant experience includes clinical or basic research in a Pharmaceutical company, Medical device/Diagnostic company, ARO, or CRO. CRA experience preferred.
• Travel: 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