Associate Director, Data Management
Company: Otsuka Pharmaceutical
Posted on: January 25, 2023
Otsuka is a healthcare company driven by our purpose and defined
by our beliefs. Otsuka DM is part of the Clinical Analytics
department and supports the efficient and effective development and
delivery of the clinical pipeline. The Associate Director of Data
Management supports the Director in providing leadership,
direction, and operational management for the data management team.
This is a leadership position responsible for line managing,
developing and accountability for the Protocol Data Managers in
their assigned program; and for meeting assigned operational
targets including but not limited to quality, performance,
utilization, retention and training.At a program level, the
Associate Director of Data Managment will act as Data Management
expert to develop data management strategies, identify and
implement methodologies and technologies to best support projects.
Responsibilities will include:
- Drive continual improvement across a program and effectively
share lessons learned and best practices across
- Represent Clinical Data Management on the program governance
teams / joint operations committees.
- Manage the scope, budget, and resources for assigned
- Develop and maintain SOPs and working practice documents for
data management tasks in collaboration with representatives from
other functions and therapeutic areas.
- Proactively identify risks and executes risk mitigation
- Maintain timely communication with management and
- Establish and manage data capture, management, and review
standards to ensure the quality and integrity of clinical research
data in compliance with global regulatory requirements.
- Provide consultation, leadership, and expertise to clinical
development functions in the areas of data handling and data
- Evaluate Electronic Data Capture (EDC) and other data
collection technologies for implementation.
- Participate in the development and maintenance of standard
eCRFs and associated edit specifications.
- Represent data management on key company initiatives.
- Participate in new hire process, onboarding activities,
mentoring and training of DM staff.
- Line management and setting performance expectations for
assigned direct reports.Qualifications/ RequiredKnowledge/
Experience and Skills:
- Demonstrate project management experience with ability to
perform under tight timelines while balancing conflicting
- Management skills to accomplish work through others and
maintain appropriate relationships.
- Experience working with and managing external service
- Working knowledge of data management process for clinical
trials and current regulations.
- Deep understanding of ICH GCP guidelines, CDASH standards, and
other applicable regulatory rules and guidelines.
- Strong organizational, time management, and resource-allocation
skills with the ability to perform and prioritize multiple tasks
and programs with excellent attention to detail.
- Experience with regulatory audits and inspections.
- Excellent communication, interpersonal, and presentation
- Bachelor's or Master's degree (preferred) with a minimum of 10
years of experience in pharmaceutical industry#MS1
Keywords: Otsuka Pharmaceutical, Rockville , Associate Director, Data Management, Executive , Rockville, Maryland
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