|新着求人 モニター (MM-38)|
|募集職種||外資系製薬企業の Senior CRA in Oncology Clinical Operations
■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.
University Degree or above
・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.