External Bioanalytical Study Monitor
Company: Labcorp Drug Development - USA
Location: Indianapolis
Posted on: March 19, 2023
|
|
Job Description:
Get ready to redefine what's possible and discover your
extraordinary potential. Here at Labcorp Drug Development, you'll
have the opportunity to personally advance healthcare and make a
difference in peoples' lives with your bold ideas and unique point
of view. With the support of exceptional people from across the
globe and an energized purpose, you'll be empowered to own your
career journey with mentoring, training and personalized
development planning. Join us as we speed the delivery of
groundbreaking therapies and anticipate tomorrow's drug development
challenges, creating new possibilities for our clients-and your
career. The Company - LabCorp Drug Development As one of the
world's largest and most comprehensive drug development services
companies, LabCorp Drug Development has helped pharmaceutical and
biotech companies develop one-third of the all prescription drugs
in the marketplace today. The Position As an External Bioanalytical
Study Monitor, you will act as the primary interface and liaison
between Labcorp Bioanalytical Laboratories globally and the Sponsor
clinical study teams and Sponsor bioanalytical group. This role
will include direct leadership and representation on behalf of the
Sponsor for the execution of the bioanalytical strategy on the
Sponsor's own clinical studies. The oversight and guidance provided
will cover the entire clinical lifecycle from planning phase and
study execution to reporting. The extent of the bioanalytical
monitoring is determined by the work placed by the Sponsor, the
majority of the monitoring covers biologics (large molecule),
however oversight of small molecule may also be required. About the
Job Responsible for representing the Sponsor as a primary liaison
with the Sponsor clinical study teams for all matters relating to
bioanalytical planning, execution and reporting to the Labcorp
Bioanalytical Services global network Work with the Sponsors
Bioanalytical Representative to understand the scientific and
regulatory bioanalytical strategy for each clinical study for which
they are responsible Provide a clear point of focus and consistency
of execution for the Sponsor by informing staff of specific
requirements as outlined and agreed to by the Sponsor clinical
study teams Maintain and monitor all ongoing projects against the
Sponsor timetables, including the maintenance of Sponsor specific
systems and documentation the maintenance and provision of project
tracking tools Provide status reports and updates in a timely
manner to the Sponsor and their clinical study teams Coordinate and
manage projects within the designated therapeutic areas and provide
the Alliance sponsor with consultancy and advisory counsel for
execution of the Bioanalytical strategy for each clinical study in
their area of responsibility Responsible for the final verification
of data quality and integrity for the Sponsor clinical study teams
The primary liaison for harvesting workload forecast information
and translating clinical study team plans and timetables into
actionable demand forecasts for the Labcorp global bioanalytical
organisation Maintain and develop all aspects of scientific and
regulatory knowledge required to provide the rationale for the
successful execution of bioanalytical study activities for the
Sponsor clinical study teams Collaboration with Labcorp Central
Laboratory teams to ensure seamless delivery across multiple
business units. Requirements Master, Chemistry/Biochemistry or
related field Extensive knowledge of drug development process
Minimum 5 years industry experience in a relevant field Prior
experience in scientific/regulatory oversight for Bioanalytical
Clinical sample data generation. Demonstrated track record in a r
egulated environment for GCP and GLP testing Proven ability to
prioritize and manage time Proven ability to get things done by
influencing others Proven ability to communicate effectively at all
levels with other Labcorp employees, as well as external Sponsors,
suppliers, etc. Computing skills, including word processing and use
of spreadsheets (e.g. Microsoft Office packages). Recommended:
Commercial awareness, interpersonal and negotiating skills. Project
management skills and qualifications. Learn and maintain knowledge
of process excellence processes, tools and activities. Scope The
role covers monitoring of work carried out in global locations The
role is primarily office based (hybrid work from home arrangements
are a possibility). Travel may be required for Sponsor visits and
conferences Labcorp is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Labcorp strives for diversity and inclusion
in the workforce and does not tolerate harassment or discrimination
of any kind. We make employment decisions based on the needs of our
business and the qualifications of the individual and do not
discriminate based upon race, religion, color, national origin,
gender (including pregnancy or other medical conditions/needs),
family or parental status, marital, civil union or domestic
partnership status, sexual orientation, gender identity, gender
expression, personal appearance, age, veteran status, disability,
genetic information, or any other legally protected characteristic.
We encourage all to apply. For more information about how we
collect and store your personal data, please see our Privacy
Statement .
Keywords: Labcorp Drug Development - USA, Indianapolis , External Bioanalytical Study Monitor, Other , Indianapolis, Indiana
Click
here to apply!
|