Clinical Study Manager
Company: Labcorp
Location: Wilmington
Posted on: January 24, 2023
Job Description:
Clinical Study ManagerRemote - United StatesWhy settle for one
thing when you can have everything? Labcorp Drug Development gives
you the best two for one opportunity for career growth. Who doesnt
want twice the perks working at one of the largest FSP CROsand
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 aClinical Study Manager 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:o Review and approval of key monitoring documents/plans,
periodic review of outputs, decisions and actions related to
monitoringo Conduct Oversight Monitoring Visits, as applicableo
Review and endorsement of relevant study plans, as applicableo
Study team meeting management and attendance when necessary;
regular review ofmeeting agendas and minuteso 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 studyo Documented review and monitoring of issues,
risks and decisions at the study level and implementation of
appropriate mitigation strategieso Review and ownership of trial
operational data (e.g. CTMS)o 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 managementRequirements:
- Bachelors 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: $116,200 -$136,200.98/yearBenefits:
All job offers will bebased on a candidates skills and prior
relevant experience, applicabledegrees/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.#LI-RemoteLabcorp 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.Required
Keywords: Labcorp, Wilmington , Clinical Study Manager, Executive , Wilmington, Delaware
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