What are the responsibilities and job description for the Sr Clinical Study Assoc CO position at Daiichi Sankyo US?
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).
Responsibilities
Job Description
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
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).
Responsibilities
Job Description
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
Salary : $100,960