Manager, Data Management - Lab Specialist
Company: Daiichi Sankyo, Inc.
Location: Basking Ridge
Posted on: May 3, 2021
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 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. Job
Summary:The position manages the end-to-end delivery of data
management services for assigned projects/studies, collaborating
with CROs and other vendors to ensure high quality deliverables on
time and within budget to support drug development processes and
global submissions. This position provides leadership within Data
Management by partnering with internal and external stakeholders to
deliver clinical trials timeline focused on Oncology. Additionally,
this position will contribute to the Data Management process
improvements, technology assessments, and standards.
- Serve as the subject matter expert and take leadership role in
managing the process of external lab data, such as standardizing
and harmonizing the procedures including but not limited to central
lab, bioanalytical data, ECG, central read or other non-CRF data.
Specifically, take leadership in electronic data acquisition,
standard data structures and procedures to support downstream
analysis. Will serve in the leadership role in the interaction with
the cross-functional teams to ensure optimal external data
- Serve in the leadership role in managing local lab processes,
including review and approval of new analytes, naming conventions
or synonyms, new units, conversion factor, or templates. Will
interact directly with internal stakeholders as well as Japan and
European teams to ensure related harmonization.
- Serve as the subject matter expert in the local laboratory
parameters: Analytes, Synonyms, Units, Conversion Factors,
Laboratory Names, related templates and other standard elements.
Review and approve new requests from studies for the local lab
parameters mentioned above. Reach out to the pertinent departments
for consultation when needed.
- Interact with Japan and/or other regional lab experts in
harmonization of standard local lab parameters. Take leadership in
the SOP/SOI concerning external data management, including standard
data structure, transfer and reconciliation. Take leadership in the
standard templates including standard EFTS. Serve as the subject
matter expert in the standard lab data structures, Naming
Conventions, Codelists concerning the laboratory/electronic
- Serve as the subject matter expert for consultation in lab data
set up during study protocol review, oversight on study lab setup,
UAT or study templates. Serve as the subject matter expert in
support of study level EFTS and reconciliation spec/process.
- Support lab related CRF design from both global and study
- Participate in the global or cross-functional initiatives
related to lab data. Update Management of progress made in lab
related initiatives or related risks. Perform other tasks as
requested by management.Qualifications: Successful candidates will
be able to meet the qualifications below with or without a
reasonable accommodation. Education/Experience:
- Bachelor's Degree/Master's Degree or RN in life sciences or
related field preferred. Training in Clinical or Life Science
- Minimum overall experience of 4 years with clinical data
management systems and clinical trials experience.
- Medical or laboratory background with understanding of
laboratory tests, safety ranges, procedures and conversion factors,
as well as associated regulations and industry standards.
- Knowledge of Medidata RAVE clinical database system and Lab
Admin module preferred.
- Excellent interpersonal, verbal and written communication
- Superior Project Management skills.
- Ability to work independently and exercise critical thinking
and judgment. 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.
Keywords: Daiichi Sankyo, Inc., Newark , Manager, Data Management - Lab Specialist, Executive , Basking Ridge, New Jersey
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