Associate Director, Data Management (Remote, US)

Overview

Entrepreneurial Spirit, Rooted in Tradition. Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a U.S. subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC) in Japan, which touts a storied reputation more than 300 years in the making. Our parent company - one of Japan’s most respected - is a research-driven pharmaceutical company that has tirelessly pursued medical breakthroughs with global reach. MTPC has discovered and produced several first-in-class medicines for serious diseases, including multiple sclerosis (MS), diabetes mellitus (DM), amyotrophic lateral sclerosis (ALS), and is currently developing medicines in  Neurology in Parkinson’s (PD), Spinal Cord Injury (SCI), and in high unmet areas in Immunology and Oncology.

MTPA is rapidly expanding its operations across all functional areas. MTPA’s commitment to patients and their communities continues with a robust late-stage pipeline of investigational treatments for difficult-to-treat diseases and commercializing products with significant unmet medical needs in North American markets.  In the United States, MTPA launched rare disease treatments including RADICAVA® (edaravone) injectables in 2017 and RADICAVA® (edaravone) oral suspension in 2022.  The company handles research, clinical development, sales, marketing, medical affairs, supply chain, and business development functions.  MTPA is dedicated to improving the treatment environment for those with debilitating diseases, researching on real-world evidence, and creating hope for all facing illness.

The Associate Director, Data Management is responsible for oversight of data management for clinical development studies within all MTPA therapeutic areas. The Associate Director works with departmental and cross-functional teams to support the design, implementation, and maintenance of hard copy and/or electronic solutions for data acquisition in MTPA clinical development studies. The Associate Director functions in a department with a strong electronic data capture orientation, and he/she is responsible and leads all operational aspects of the projects in Clinical Data Management.

Responsibilities

• Responsible for all data management related operations for MTPA clinical development programs.
• Develop specific strategies and processes. Continually evaluates processes and applications for improvements, to ensure data management standards and processes are implemented and maintained across the projects and studies at MTPA.
• Liaise with other internal partners, e.g.: Biostatistics, Clinical Operations, Safety, Quality Assurance, Regulatory Affairs and external partners, e.g.: CROs, to ensure standards and processes are agreed in cooperation with other functions, implemented and
• maintained across the functions and studies.
• Effective leadership of CDM project and study teams. Supervise Data Management personnel to provide guidance and solve data management issues. Implements an appropriate process for communication, regular meetings, and telephone conferences.
• Provide solutions to data management issues that arise in the project teams to ensure that projects/studies are performed with a high quality to support submissions to regulatory authorities.
• Negotiate responsibilities and timelines. Ensure CRF/DB design and coding activities are appropriately considered in project decisions. Oversees process implementation and coordinates resource activities with project/study team. Propose solutions for data
• management issues for project teams.
• Review Clinical Data Management related documentation to assure that regulatory standards, standardization and quality, and simplification of processes are maintained.
• Evaluate the objectives, performance, career and training needs of his/her DM associates in cooperation with the Department Head.
• Participate in process and technical improvement initiatives.
• Participate in review and updating of established data management SOPs and working practices.
• Perform other departmental duties as assigned.

Qualifications

• Minimum B.S. in computer science, bioscience, medical training or equivalent in a closely related field. MS/MA preferred.
• Minimum of 8 years data management experience in the pharmaceutical industry
• Experience with clinical data management systems (CDMS) and electronic data management/remote data capture systems (EDC/RDC).
• Knowledge of the drug development process and regulatory requirements.
• Knowledge of IT systems, medical terminology and CDISC/STDM.
• Strong interpersonal and communication skills and ability to collaborate effectively with other groups in a matrix organization.

Our Value Proposition:

Enjoy the fast-moving, entrepreneurial spirit mor