Clinical Project Manager II - Clinical Trials
Company: Labcorp Drug Development, Labcorp
Location: Syracuse
Posted on: May 28, 2023
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: -
- Review and approval of key monitoring documents/plans, periodic
review of outputs, decisions and actions related to monitoring
-
- Conduct Oversight Monitoring Visits, as applicable -
- Review and endorsement of relevant study plans, as applicable
-
- Study team meeting management and attendance when necessary;
regular review of -meeting agendas and minutes -
- Review 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 -
- Documented review and monitoring of issues, risks and decisions
at the study level and implementation of appropriate mitigation
strategies -
- Review and ownership of trial operational data (e.g. CTMS)
-
- -Reviewing 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 (e.g. clinical trial assistant/associate or lead
CRA). Advanced degree(s) (e.g., Master or Doctorate) and relevant
training or experience (e.g., fellowship. internships, etc.) may be
considered to supplement experience requirements.
- Experience could include either early phase clinical studies or
Phase 2 and 3 studies and global/international studies or programs.
Experience in more than one therapeutic area is advantageous. -
-
- Knowledge in global regulatory and compliance requirements for
clinical research, including US CFR, EU CTD, and ICH GCP. Awareness
of local country requirements is also required. -
- Demonstrated successful experience in project/program
management and matrix leadership E.g. timeline/budget management.
-
- Effective communication skills.
- Excellent teamwork, organizational, interpersonal, and
problem-solving skills Fluent business English (oral and
written).
- Vendor selection and oversight experience preferred
- Requires estimated 5-20 % travel, including overnight and
international travel - 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. - #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 ourPrivacy Statement.
Keywords: Labcorp Drug Development, Labcorp, Syracuse , Clinical Project Manager II - Clinical Trials, Executive , Syracuse, New York
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