|部署・役職名||Senior CRA, Oncology|
■The senior Clinical Research Associate （Sr .CRA） is accountable and responsible for Country Lead Monitor for assigned oncology studies. The CLM leads assigned Japan local monitoring team and works in close collaboration with global study team. The Sr CRA all aspect of site management and monitoring activities for assigned applicable Phase I and all Phase II －IV clinical investigator sites as CLM. These global, complex studies are conducted with the standards set by Bayer Global Development, according to Good Clinical Practices （ICH－GCP） and applicable regulatory and legal requirement.
■Managing investigator sites and site activities and monitoring site data, to ensure patient safety and ethical and regulatory compliance necessary to provide quality data required for global regulatory submissions for approval of drugs.
■Managing investigator sites to ensure the investigator and site staff meet all aspects of study delivery and commitments to make certain the operational study execution is on track from site selection to site close out.
■Rigorous regulatory guidelines exist to ensure overall patient safety related to reporting of serious or unexpected adverse drug reactions. The Sr. CRA is responsible for training the investigator and site staff on these strict regulations and procedures for timely reporting and as well as monitoring ongoing compliance. Strict adherence is essential to remain compliant with on time reporting from Bayer to regulatory authorities and critical for thorough and timely evaluation of patient safety.
■Due to the highly regulatory clinical trial environment, the Sr. CRA proactively identifies potential issues and develops site Corrective Actions / Preventive Actions （CAPAs） plans. The Sr CRAs ensure timely and sufficient resolution of issues and may impact compliance or quality of study related activities or data.
■As key contributor to the （e）Trial Master File and study documents at the country level, ensures essential documents are appropriate and filed in a timely manner in the investigator Site File.
■Incumbent is a key contributor in the preparation, conduct and follow up of site audit and regulatory inspections to ensure successful outcomes. The Sr. CRA is a member of the audit/regulatory inspection team.
■Due to experience and expertise in oncology clinical studies, the Sr CRA may be a mentor and role model for new or less experienced CRAs on process, study, technical or behavioral competencies. The Sr. CRA may also conduct co－monitoring visits as defined in the study monitoring plan to mitigate risks and ensure the quality and reliability
【必須（MUST）】■At least 5 years clinical operations experience in the pharmaceutical industry and at least 1－2 years clinical operations experience in the Oncology Field
■At lease 2 years of clinical trail/study management as a leader experience preferred.
※The incumbent is responsible for management of Phase II－IV complex and global/Local clinical trials.
■This requires an in－depth knowledge of oncology field, Good Clinical Practices （GCP）, federal reg
■Fluency in Japanese, English TOEIC 730 and above
・Ensuring accountability and consistently achieving results, even under tough circumstances.
・Recognizing the value that different perspectives and cultures bring to an organization.
・Planning and prioritizing work to meet commitments aligned with organizational goals.
・Stepping up to address difficult issues, saying what needs to be said.