Provides leadership and day-to-day guidance to CROs and OPDC functional areas for assigned protocols. Interacts with expert physicians, investigators, vendor/CRO personnel, and functional area staff to ensure that the clinical protocol(s) are run according to ICH, FDA, and OPDC guidelines. Ensures compliance with FDA and international regulations, GCPs, and SOPs.
Knowledge: Comprehensive knowledge of clinical operations; thorough knowledge of the drug development process, roles and responsibilities of individuals within the project team, SOPs and GCP/ICH regulations, contract research organizations, outsourcing, and evaluation of work perfomed against vendor Statement of Work. Understanding of the clinical and scientific basis for assigned protocols.
Skills: Strong communication, organization, planning, analytical, problem solving, and people management skills. Demonstrated experience with working with the Microsoft suite of programs (Word, Excel, Powerpoint, Outlook). Good understanding of clinical trial related software (eCRFs, IWRS, CTMS).
Required: Bachelor’s degree in a health science field, or nursing degree. Minimum of 5 years in the pharmaceutical industry and 4 years clinical trial management or monitoring experience.
Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.
In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.
Otsuka Pharmaceutical Company is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 45,000 people worldwide and had consolidated sales of approximately USD 11 billion (€ 9.9 billion) in 2016.
All Otsuka stories start by taking the road less travelled. Learn more about Otsuka Pharmaceutical Company on its global website at www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com.
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.