Clinical Project Manager II - Clinical Trials
Company: LabCorp
Location: Richmond
Posted on: May 27, 2023
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Job Description:
Clinical Project Manager II - Clinical Trials
Remote - United States
As a leading global contract research organization (CRO) with a
passion for scientific rigor and decades of clinical development
experience, Fortrea provides pharmaceutical, biotechnology, and
medical device customers a wide range of clinical development,
patient access and technology solutions across more than 20
therapeutic areas. With over 19,000 staff conducting operations in
more than 90 countries, Fortrea is transforming drug and device
development for partners and patients across the globe.
Did you know?
Labcorp's Clinical Development and Commercialization Services
business is now Fortrea in connection with its planned spin-off
from Labcorp, which is expected in mid-2023. Fortrea's spin-off
from Labcorp is subject to satisfaction of certain customary
conditions. This spin-off will position both organizations for
accelerated growth and allow each to focus resources on distinct
strategic priorities, customer and employee needs and value
creation opportunities.---As a provider of phase I-IV clinical
trial management, regulatory guidance, patient access solutions and
market access consulting, Fortrea will partner with both emerging
and large pharmaceutical, biotechnology, device and diagnostic
companies to drive healthcare innovation and improve the lives of
patients worldwide.
Fortrea is looking for problem-solvers and creative thinkers who
are passionate about breaking down barriers faced by sponsors of
clinical trials, and who are committed to helping transform the
development process to get promising life-changing ideas and
therapies to patients faster. Join us as we cultivate a workspace
where all employees have the opportunity to grow and make impacts
on a global scale. For more information and questions related to
Fortrea, please visit www.fortrea.com .
Why settle for one thing when you can have everything? Fortrea
gives you the best two for one opportunity for career growth. Who
doesn't want twice the perks - working at one of the largest FSP
CROs-and partnering with one sponsor with a dedicated therapeutic
focus.
Our Energizing Purpose, Exceptional People and Extraordinary
Potential combined with collaborative and proactive teams offer a
great place for you to continue honing your therapeutic skills and
growing and excelling in new exciting research. Our reach is global
- extending to 60+ countries making us one of the largest FSP CROs.
So, no matter where you are located on the globe, we have an FSP
opportunity for you.
We are seeking a Clinical Project Manager II who will support team
with study budget planning and management and accountable for
external spend related to study execution.
Responsibilities
Works closely with Clinical Operations Program Leader(s), Global
Program Management, and Finance to ensure on a regular basis that
budgets, enrollment, and gaiting are accurate
Communicates study status, cost and issues to Clinical Operations
Program Lead(s); serve as escalation point for third party vendors
managed by Strategic Partner and/or other CROs
Oversee Strategic Partners/CRO/vendor selection, budget and
contract negotiation, and proper supervision of performance for all
activities assigned to a Strategic Partner/CRO/vendor for assigned
studies, including escalation of issues to governance committees
when warranted
Specific areas of sponsor oversight include, but are not limited
to: oReview and approval of key monitoring documents/plans,
periodic review of outputs, decisions and actions related to
monitoring oConduct Oversight Monitoring Visits, as applicable
oReview and endorsement of relevant study plans, as applicable
oStudy team meeting management and attendance when necessary;
regular review of meeting agendas and minutes oReview of
outcomes/actions related to protocol deviations review; primary
purpose of review is to support the identification of trends across
sites and/or the study oDocumented review and monitoring of issues,
risks and decisions at the study level and implementation of
appropriate mitigation strategies oReview and ownership of trial
operational data (e.g. CTMS) oReviewing and oversight of internal
trial reports
In partnership with data management, review and pressure test all
database timelines and plans; ensure strong linkage between the
strategy (i.e., filing/registration, data generation, etc.) with
the tactical plan for database lock and CSR.
Ensure studies are "inspection ready" at all times; may be involved
in regulatory inspections by preparing for and/or attending the
inspections.
Site relationship management
Requirements :
Bachelor's Degree or international equivalent required; Life
Sciences preferred
5+ years' experience in pharmaceutical industry and/or clinical
research organization, including 3+ years of clinical study
management/oversight, including significant study management
support experience
Experience in either early phase clinical studies or Phase 2 and 3
studies and global/international studies or programs
Experience in more than one therapeutic area preferred
Knowledge in global regulatory and compliance requirements for
clinical research, including USCFR, EUCTD, and ICHGCP
Awareness of local country requirements also required
Demonstrated successful experience in project/program management
and matrix leadership E.g. timeline/budget management
Vendor selection and oversight experience required
Patient enrollment and oversight experience required
Experience leading inspection readiness required
Experience leading study close-out required
Effective communication skills
Excellent teamwork, organizational, interpersonal, and
problem-solving skills
Fluent business English (oral and written)
Travel Requirements:
Pay Range: $85,000 - $155, 000/year
Benefits: All job offers will be---based on a candidate's skills
and prior relevant experience,
applicable---degrees/certifications,---as well as internal equity
and market data.---Regular, full-time or part-time employees
working 20 or more hours per week are eligible for comprehensive
benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K),
ESPP, Paid time off (PTO) or Flexible time off (FTO), Company bonus
where applicable. For more detailed information, please click here
(https://cdn.phenompeople.com/CareerConnectResources/COVAGLOBAL/documents/Labcorp-Benefits-TheWayWeLive-1659629596356.pdf)
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#LI-Remote
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
(https://www.labcorp.com/hipaa-privacy/web-privacy-policy) .
Keywords: LabCorp, Richmond , Clinical Project Manager II - Clinical Trials, Accounting, Auditing , Richmond, Virginia
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