Manager, Data Management
- Daiichi Sankyo
- Basking Ridge, NJ
- Start date
- Mar 23, 2023
- Information Technology, Business/Data Analytics, Science/R&D
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Pharm Country
- Leadership, Direction, and Strategy:
- Establishes Data Management strategy at the project and/or study level for a smaller number of projects/studies Proactively identifies and manages risks at the project and/or study level for a smaller number of projects/studies
- Project Management:
- Plans and directs the conduct of Data Management activities for assigned projects/studies through outsourcing (e.g., study startup, study conduct, study closeout, and reporting).
- Provides oversight for Data Management CRO and other third party vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, Policies, SOPs, and other relevant guidelines.
- Ensures Data Management deliverables meet/exceed project/study team expectations regarding quality, time, and cost and that Data Management documentation is filed/archived according to applicable Daiichi Sankyo and regulatory requirements.
- Functional Expertise:
- Reviews/approves clinical study related documents (e.g., Protocols, Data Management Plan, Clinical Study Reports).
- Leads and drives the data review process in collaboration with the study team to ensure data quality
- Participates in audits and inspections.
- Operational Efficiency / Continuous Improvement:
- Provides comprehensive data management expertise to project/study teams to optimize study-specific clinical trial processes.
- May participate in process improvement initiatives.
- Master's Degree in life sciences or related field (or equivalent experience) preferred
- Bachelor's Degree in life sciences or related field required
- RN in life sciences or related field (or equivalent experience) preferred
- 4 or more years data management and/or related industry work experience in a medical device, pharmaceutical company, or similar environment (e.g., CRO) preferred
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology.
With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
For more information, please visit: www.daiichisankyo.com.
Daiichi Sankyo, Inc., headquartered in Basking Ridge, New Jersey, is a member of the Daiichi Sankyo Group. To learn more about Daiichi Sankyo, Inc., please visit www.dsi.com.
STOCK EXCHANGE: Tokyo Stock Exchange
STOCK SYMBOL: 4568
- (908) 992-6400
211 Mt. Airy Road
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