Daiichi Sankyo
Manager, External Data Management
Daiichi Sankyo, Trenton, New Jersey, United States,
Join a Legacy of Innovation 110 Years and Counting!
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 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. 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.SummaryThe Manager External Data Management is accountable for an end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with Clinical and Medical teams, Functional Stakeholders, Clinical Safety, CROs, and External Vendors for the data services they provide to support drug development processes and global submissions. This position provides expertise within Data Management by partnering with internal and external stakeholders to optimize data collection services on behalf of Daiichi Sankyo. This position also ensures quality delivery of all 3rd party data from diverse external providers for clinical trials, companion diagnostics trials, clinical development, and regulatory submissions. The position will perform validation of the electronically transmitted external data by ensuring all clinical & companion diagnostics data meet quality requirements and protocol defined analysis endpoints. This position also requires knowledge of external data concepts, working knowledge of data collections (EDC & Non-EDC), industry standards (CDISC / SDTM), and technical skills for integrating and importing external data received from CROs, Vendors and/or Partners. Performing oversight and execution of CDx development to facilitate science-based CDx decision making would be preferable. In addition, excellent verbal/written skills, analytical, organizational, and interpersonal skills for working effectively with people at different levels are required for this role.ResponsibilitiesLeadership, Direction, and Strategy:
Leads implementation of Program/Therapeutic level external data collection requirements by partnering with internal and external stakeholders to drive consistency of data acquisition, processing, and reporting of diverse external data across DS Programs. Participates in Contract/SOW reviews and MSA discussions of External Vendors by engaging with key cross-functional stakeholders for establishing data collection, data standards, and data cleaning needs for DS Programs/Studies.Project Management:
Provides guidance for collection of all external data management deliverables for assigned DS Program/Studies by ensuring consistency of external data standards. Is accountable for quality delivery of diverse external data for DS Programs/Studies operating under the outsourced and in-house operating models.Functional Expertise:
Ensures all external data contains protocol specified parameters, is in correct format and aligns with the approved EFTs and eDTS. Participates in review of Test and Production data transfers for diverse data sets and identifies any erroneous data.Operational Efficiency / Continuous Improvement:
Facilitate science-based CDx decision making for data transfers coming to Daiichi Sankyo, maintain focus on IVD products by collaborating with Diagnostic Partners and technologies.Qualifications:
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education Qualifications (from an accredited college or university)
- Master's Degree in life sciences or related field (or equivalent experience) preferred- Bachelor's Degree in life sciences or related field (or equivalent experience) required- RN in life sciences or related field (or equivalent experience) preferredExperience Qualifications
- 4 or more years external data management background and strong knowledge of 3rd party vendor management and oversight of external data standards. Knowledge of CDISC and SDTM and industry standard data collection practices required.- 4 or more years Clinical data management experience in a medical device, pharmaceutical company, or similar environment (e.g., CRO); oncology, immunology, or complex disease therapeutic area is a must.Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
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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 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. 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.SummaryThe Manager External Data Management is accountable for an end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with Clinical and Medical teams, Functional Stakeholders, Clinical Safety, CROs, and External Vendors for the data services they provide to support drug development processes and global submissions. This position provides expertise within Data Management by partnering with internal and external stakeholders to optimize data collection services on behalf of Daiichi Sankyo. This position also ensures quality delivery of all 3rd party data from diverse external providers for clinical trials, companion diagnostics trials, clinical development, and regulatory submissions. The position will perform validation of the electronically transmitted external data by ensuring all clinical & companion diagnostics data meet quality requirements and protocol defined analysis endpoints. This position also requires knowledge of external data concepts, working knowledge of data collections (EDC & Non-EDC), industry standards (CDISC / SDTM), and technical skills for integrating and importing external data received from CROs, Vendors and/or Partners. Performing oversight and execution of CDx development to facilitate science-based CDx decision making would be preferable. In addition, excellent verbal/written skills, analytical, organizational, and interpersonal skills for working effectively with people at different levels are required for this role.ResponsibilitiesLeadership, Direction, and Strategy:
Leads implementation of Program/Therapeutic level external data collection requirements by partnering with internal and external stakeholders to drive consistency of data acquisition, processing, and reporting of diverse external data across DS Programs. Participates in Contract/SOW reviews and MSA discussions of External Vendors by engaging with key cross-functional stakeholders for establishing data collection, data standards, and data cleaning needs for DS Programs/Studies.Project Management:
Provides guidance for collection of all external data management deliverables for assigned DS Program/Studies by ensuring consistency of external data standards. Is accountable for quality delivery of diverse external data for DS Programs/Studies operating under the outsourced and in-house operating models.Functional Expertise:
Ensures all external data contains protocol specified parameters, is in correct format and aligns with the approved EFTs and eDTS. Participates in review of Test and Production data transfers for diverse data sets and identifies any erroneous data.Operational Efficiency / Continuous Improvement:
Facilitate science-based CDx decision making for data transfers coming to Daiichi Sankyo, maintain focus on IVD products by collaborating with Diagnostic Partners and technologies.Qualifications:
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education Qualifications (from an accredited college or university)
- Master's Degree in life sciences or related field (or equivalent experience) preferred- Bachelor's Degree in life sciences or related field (or equivalent experience) required- RN in life sciences or related field (or equivalent experience) preferredExperience Qualifications
- 4 or more years external data management background and strong knowledge of 3rd party vendor management and oversight of external data standards. Knowledge of CDISC and SDTM and industry standard data collection practices required.- 4 or more years Clinical data management experience in a medical device, pharmaceutical company, or similar environment (e.g., CRO); oncology, immunology, or complex disease therapeutic area is a must.Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
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