Associate Director, Data Management
Company: Daiichi Sankyo, Inc.
Location: Paterson
Posted on: August 6, 2022
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Job Description:
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. 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.SummaryPosition 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 optimize Data Management
technology, processes, and standards. Additionally, this position
develops/proposes strategies within Data Management and
collaborates cross-functionally to ensure successful outcomes for
projects/studies.This position has strong knowledge of Electronic
Data Capture/related applications and industry standards, and
strong skills in working with data received from CROs and other
third party vendors. This position has solid verbal/written skills,
analytical, organizational, and interpersonal skills and works
effectively with people at different levels and from different
disciplines and cultures. Additionally, this position possesses
advanced knowledge of clinical operations and processes and
relevant regulatory requirements. This position has experience
working on Phase I-IV study studies within the medical device
and/or pharmaceutical industry across multiple therapeutic areas
and experience with regulatory submissions and inspections.
Finally, this position has strong skills in continuous improvement,
project management, change management, and risk
management.ResponsibilitiesLeadership, Direction, and
Strategy:Provides data management (DM) expertise and guidance to
the project team regarding the data management DM activities and
deliverablesEstablishes Data Management strategy at the project
and/or study level for a larger number of projects/studies with
greater complexity.Ensures data management deliverables for all
studies within the project/program level meets quality, time and
cost effectiveLeads functional and/or multidisciplinary teams
working on projects/studies and/or initiatives.Lead and manage the
standardized Data Management Process and Procedures for consistency
across programs and organizationProactively identifies and manages
risks at the project and/or study level for a larger number of
projects/studies with greater complexity.May manage Data Management
full-time and/or contract staff.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 that are owned by other functions
(e.G., Protocols, Statistical Analysis Plans, Clinical Study
Reports).Actively participates in audits and
inspections.Operational Efficiency / Continuous
Improvement:Provides leadership within Data Management by
partnering with internal and external stakeholders to optimize Data
Management technology, processes, and standards (improving
quality/inspection readiness, decreasing cycle times, and reducing
costs).Leads multidisciplinary process improvement
initiatives.Leverages comprehensive Data Management expertise to
promote best practices across the Clinical Trial
lifecycle.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
preferredBachelor's Degree in life sciences or related field
preferredExperience Qualifications7 or More Years data management
and/or related work experience in a medical device or
pharmaceutical company, or similar environment (e.G., CRO)
preferred4 or More Years combined experience managing people and/or
initiatives preferredDaiichi 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., Paterson , Associate Director, Data Management, Executive , Paterson, New Jersey
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