Manager, GCO Functional Excellence
Company: Daiichi Sankyo, Inc.
Location: Atlanta
Posted on: April 15, 2024
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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 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.
Summary
The Manager, Global Clinical Operations (GCO) Functional Excellence
(FxExc), will help support and may manage day to day functional
excellence activities to include, but not limited to, the project
management of workstreams and strategic imperatives, training and
onboarding, metrics activities, participate in GCO vendor
assessment, and tracking od vendors and assessment status. In
addition, this role will support the FxExc Director in lead
innovation and optimization by gathering industry expertise and
trending to shape the future of Daiichi Sankyo clinical
trials.Responsibilities- Process Improvement, Innovation and
Optimization (IO):-Project manage GCO Strategic Imperatives (SIs)
and process improvement workstreams, partnering with
cross-functional subject matter experts.-Support the build of
industry expertise in innovation and optimization for clinical
trials.-Utilize strategic conferences for information mining and
networking, engage more with organizations such as Transcelerate,
WCG/Avoca, SCOPE, SCRS, DIA, etc.-Work with and/or support subject
matter experts to determine needs and build business cases for
implementation of IO tools.-Assist with the tracking of vendors -
vendor assessment status and final choices, in collaboration with
RD Procurement, who leads the vendor assessment
process.-Participate with other FxExc teams within Daiichi Sankyo
to optimize cross-functional improvements.-Support creation and/or
maintenance of templates (tools, guidance documents, execution
plans, Visio and/or Project process mapping), and/or Power
Pointpresentations, as needed.- GCO Training:-Contribute to the
creation and/or maintenance of GCO Onboarding training.-Assist with
the maintenance of the GCO training curriculum in collaboration
with Clinical Quality Management and/or QA, as
appropriate.-Participate with the identification and implementation
of learning and training related needs within GCO. Liaise with
other functions and stakeholders, asneeded.-Assist with the review
of SOPs and training documentation resulting from new processes or
process improvements and roll out GCO training and/or lessons
learned, as appropriate.- Metrics:-When needed, help support the
partnership with Clinical Trial Business Operations
(CTBO)to:-monitor GCO processes and workstream implementations for
effectiveness.-monitor key metrics and partner with process owners
to identify and address gaps/deficiencies, as needed.-track and
oversee the progress of GCO initiatives and goals through KPIs and
metrics to monitor and evaluate risks/issues across GCO and
effectiveness of initiative and/or process implementation.-Work
closely with CTBO and Alliance Management to respond to process
metrics and trending data to identify gaps, and design/implement
process improvements.-monitor and evaluate risks/issues across GCO
initiatives
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)- Bachelor's Degree Bachelor's degree with minimum of 5
years' experience in pharmaceutical or biotechnology across
clinical trial operations. Experience in training, process
improvement, and project management required
Experience Qualifications- 4 or More Years Experience in end-to-end
clinical trial processes including experience in one or more key
functions (e.g., clinical research, clinical operations, data
management, biostatistics, project management) required-
Collaboration, influencing, and change management skills in a
complex, matrix environment including project management preferred-
Experience in clinical trial design and improvement activities,
harmonization/optimization, and training and implementation
required- Six Sigma certification and/or experience with process
mapping tools (e.g., Visio, Power Point), training systems, and
metrics dashboarding preferred- Understanding of industry trends
(e.g., regulatory, technology) with ability to apply them to
process improvements preferred
Travel
Ability to travel up to 10%. For team meetings, conferences, and to
support inspections, as appropriate.
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., Smyrna , Manager, GCO Functional Excellence, Executive , Atlanta, Georgia
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