Posting Title: Senior Clinical Study Associate, Clinical Operations
About Daiichi Sankyo Cancer Enterprise
The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA.
The Senior Clinical Study Associate, Clinical Operations assist in planning and execution of clinical studies, under the supervision of a Senior Clinical Study 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 on interacting with the Contract Research Organizations (CROs) and other vendors conducting the study to help monitor compliance with Daiichi Sankyo Quality Oversight measures.
- Support and assist the transmittal of trial and site level document to the Daiichi Sankyo Document Control Center (DCC) in support of the Trial master File (TMF). Reconcile the TMF document trackers generated by the CRO with the document archive. Bring issues with the reconciliation to the attention of the Sr. Clinical Study Manager/Associate director and propose remediation plan.
- Assist in overseeing CRO collection of essential study documents at study startup, study maintenance and at follow-up after study and site close-out (e.g. document retrieval, collection of study documents for CSR appendices).
- 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.
- 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.
- 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.
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
- Qualified candidates must have a Bachelor's degree from an accredited college or university; A Bachelor's degree or assoc nursing degree/diploma with relevant clinical development experience is acceptable.
- 4 years with Associate/nursing degree, or 2 year with BS.
- 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 is preferred.
- Time spent directly in a medical environment (e.g. as a Study Site Coordinator) is also considered relevant.
- Demonstrates knowledge of complex processes related to clinical studies, regulatory issues, CRO operations, and compliance practices
- Interacts appropriately with internal and external stakeholders (e.g., CROs and other team members).
- Demonstrates foundational knowledge and application of complex compliance practices
- Effectively manages information, data, related analyses, forms and reports
- Supports and effectively multi-tasks different and complex assignments and responsibilities.
- Identifies and resolves problems when able to, escalates issues appropriately
- Familiarity with medical terminology. Working skills in computer applications, such as Microsoft Word, Excel, PowerPoint, and Outlook. Basic oral and written communication skills.
Ability to travel up to 10%
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.