Sr. Study Manager-In Vitro Diagnostics (US Remote)
Company: ICON Strategic Solutions
Location: Lincoln
Posted on: January 27, 2023
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Job Description:
Overview:The Study Manager works in close contact with the
Functional Rep and gives input into Project Teams. He/she is
interfacing with R&D, Clinical Science, Medical Affairs,
Regulatory Affairs and Biometrics in the overall design validation
planning. The Study manager is leading the Study Team with overall
accountability for study preparation, execution, and close out,
thereby ensuring that the Sponsor responsibilities are fulfilled.
The Study Manager ensures that studies are conducted to meet US/EU
requirements for CE and FDA approvals or any other applicable
regulatory requirements.Responsibilities: Leads the global study
team with full accountability for the study with respect to
quality, cost and timelines. Develops study design for technical
studies in coordination with internal/external experts and the
development project team Provides input to study synopsis prepared
by CST for Clinical Utility and Clinical Performance studies and
ensures that these Studies are planned and executed based on study
synopsis with full responsibility for study protocol and study
report Ensures that all studies are planned, executed, monitored,
closed out and documented in a competent and compliant way within
the planned time frame and costs. Ensures that the study results
are continuously validated, assessed, clear recommendations drawn
and communicated. Oversight of data management processes, data
quality and results, data base closure and reporting. Ensures that
data and reports which are necessary for the characterization,
regulatory approval and marketing of the products have been agreed
upon, made available and are documented in a timely fashion.
Ensures and is responsible that study results are presented or
submitted for publication in alignment with publication plans
Planning of the study specific content and budget within the
development project team and controlling the related agreed upon
budgets during the study. Managing study site and clinical study
agreements Delegation and oversight of tasks and work packages for
internal and external collaborators within the study. Planning,
procurement, preparation and delivery of materials necessary for
carrying out the study, in cooperation with the Study Support team.
Ensure compliance to all relevant safety and QM procedures in all
studies.Qualifications: Knowledge of applicable standards and
regulations for clinical trial and lab conduct Proven oral and
written communications skills Experience in all stages of
international clinical study management, stu_dy protocol design,
report writing and monitoring and leading local teams Proven
planning, organizing, interpersonal and leadership skills Ability
to work independently to make sound decisions and analyze and solve
problems Demonstrated experience in computer skills to include
Microsoft Word, Excel and basic templates Statistical knowledge
Minimum - Bachelor's degree in medical technology, chemistry,
biology or other science relevant field
Keywords: ICON Strategic Solutions, Lincoln , Sr. Study Manager-In Vitro Diagnostics (US Remote), Executive , Lincoln, Nebraska
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