Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.
Senior CRA in Oncology Clinical Operations
YOUR TASKS AND RESPONSIBILITIES
■The senior Clinical Research Associate (Sr .CRA) in oncology clinical operations is accountable and responsible for overall country clinical trial activities in assigned oncology studies. The CLM is a local team leader for the CRAs, point of contact of functionally outsourced monitoring activity to local CROs. In addition, oversees overall study progress for assigned studies within Japan from country feasibility assessment through to study close out to consist with country commitments with regards to all timelines, enrollment and country study budget.
■ The CLM contributes a planning of appropriate Japan development program not only conventional study design but also plat from study from clinical operational perspective in order to achieve same day filing with three region as a member of Japan project team (hereinafter JPT). In addition, the CLM acts as a leader not only the responsible monitoring team but also close collaboration with relevant functions, i.e. Project Management, Clinical Development and Regulatory Affaires, etc.
■ The CLM might take responsible for a Study Manager when RDJ executes Japan local study based on Japan development strategy.
■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.
■Rigorous regulatory guidelines exist to ensure overall patient safety related to reporting of serious or unexpected adverse drug reactions. The CLM 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 CLM proactively identifies potential issues and develops site Corrective Actions / Preventive Actions (CAPAs) plans. The CLM 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. In addition, the incumbent is a key contributor in the preparation, conduct and follow up of site audit and regulatory inspections to ensure successful outcomes.
WHO YOU ARE
■University Degree or above
■At least 6-7 years clinical operations experience in the pharmaceutical industry including 4 years clinical operations experience in the Oncology Field
■At least 2 years of study management/handling with oncology phase I as a leader are preferred.
※The incumbent is responsible for management of Japan participation of Phase I-IV complex global 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 (mandatory)
・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.
HOW TO APPLY
Please apply for the position through our recruiting website with Japanese resume, Japanese working experience and English CV.
Reference Code: 104501
Functional Area: Clinical Development & Operations