Clinical Study Manager, Clinical Operations

Job Summary

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 Description

Lead the clinical study operational aspects of planning, execution, and management of one or more Phase 1-3 clinical trials. Participate and provide expertise as a cross-functional study team member, including vendors, and liaise with other departments. Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Oversees complex vendors (i.e., eCOA). Responsible for the oversight, performance, and management of CRO(s) and 3rd party vendors (sub-contracted by CRO) to ensure compliance with Daiichi Sankyo’s quality measures and adherence to scope of work within timelines and budget at a task level. Coordinate and develop materials for CRO KOMs and Investigator meetings. Oversee site selection, start-up, monitoring, and closeout for the trial. Provide regular updates on study progress to key stakeholders. Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.). Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA