Provide oversight to OPDC Data Management operations in support of clinical development activities, including evaluating and recommending new technologies for implementation to maintain industry standards and to improve operational efficiency, ensuring compliance with applicable regulatory requirements, and assessing new SOPs and Guidance documents prior to approval and implementation.
Manages Data Management staff to support clinical development programs.
Develops and maintains working practice documents for data management tasks in collaboration with representatives from other functions and therapeutic areas.
Establishes and manages data capture, management, and review standards to ensure the quality and integrity of clinical research data in compliance with global regulatory requirements.
Provides consultation, leadership, and expertise to clinical development functions in the area of data handling and data management processes.
Evaluates Electronic Data Capture (EDC) and eSource technologies for implementation.
Develops processes in compliance with regulatory requirements (ICH/GCP) and in harmony with developing industry standards (CDISC).
Develops and implements SDTM data standards for all studies.
Works with Otsuka affiliates to standardized CRF and data management process.
Manages projects assuring timeline and budgetary compliance.
Participates in the development and maintenance of standard CRFs and eCRFs and associated edit specifications.
Participates in the screening and interview process for new hires and contractors, and provides initial general training.
Sets performance expectations for each direct report. Establishes a feedback loop among employees peers (on departmental and project teams). Provides specific and frequent feedback to the employee on his/her performance.
Train and orient new employee on corporate culture, corporate expectations and departmental/organizational policies and procedures. Works with various groups to devise training program(s) for the employee and makes arrangements for such sessions to be conducted. Ensures the employee has access to all required material, systems to satisfy their individual job responsibilities.
Other tasks assigned by Director or Sr. Director of Data Management
Travel (approximately 20%)
Understanding of the companys products and the pharmaceutical industry in general
Management skills to accomplish work through others and maintain appropriate relationships
Knowledge of the companys work tools, processes, and policies
Knowledge of data management process for clinical trials and the applicable regulations
Knowledge of computer systems in data management process, EDC, eSource and data management software
Knowledge of clinical data warehouse systems
Familiarity with ICH guidelines as applicable to global Data Management projects (Phase I-IV)
Project management, prioritization, and organizational skills, and expertise in the implementation of electronic data capture systems used in clinical studies
Experience in managing and overseeing Clinical Research Organization activities in data management function
Excellent communication, interpersonal, and presentation skills
Bachelors degree or higher with a minimum of 10 years of experience in data management, as well as pharmaceutical industry experience, including 5 years of supervisory 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 .
Disclaimer: 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.
At Otsuka, our people are passionate about developing and delivering original products as part of a global holistic commitment to better health and well-being. We have two core businesses dedicated to achieving our goals: a pharmaceutical business and a nutraceutical business. The pharmaceutical business develops and markets products for the diagnosis and treatment of disease in the following areas: central nervous system, oncology, gastroenterology, ophthalmology and cardiovascular. The nutraceutical business is dedicated to maintaining and improving health through the use of foods and beverages that provide extra health benefits in addition to their basic nutritional value. Since the beginning, nearly 100 years ago, the Otsuka family sought to develop products that stood out from the crowd, by traveling down the paths of discovery where others were less likely to tread.
We believe our culture and our people are the differentiators that empower us to produce breakthrough results. This is what makes us a big venture company that takes risks and focuses on unmet medical needs in order to develop new and better therapeutic compounds. We harness the extraordinary cr...eative and innovative abilities of our people to solve problems differently, and to persevere until they find answers. We are in this for the long-haul. Otsuka is a highly ethical company. We adhere to the highest standards in how we develop and deliver our products, and in how we treat our most valuable assets: Otsuka-people. We encourage them to follow their dreams, as turning dreams into reality is at the core of everything we do. It paves the way ahead to achieve our shared purpose: impacting on human health to help people live better lives.