Senior Study Manager
Company: Labcorp Drug Development, Labcorp
Location: Trenton
Posted on: January 26, 2023
Job Description:
Senior Study Manager - CardiometabolicRemote - USAWhy 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 aSenior Study Manager to be
responsible for operational deliverables including managing the
Clinical Trial Team (CTT), supporting clinical supplies planning,
site readiness, country allocation, and achievement of recruitment
targets.Additional responsibilities may include:
- Operational POC for trial execution and deliverables
- Manages and Leads Global CTT (Clinical Trial Team), supports
clinical supply planning, and manages external vendors
- Initiates planning for investigator meetings and protocol
training
- Plans and assesses protocol ancillary supplies
- Completes trial set up and maintains CTMS
- Initiates recruitment/retention and enrollment planning for
protocols (globally)
- Responsible for creating and maintaining project schedule and
collaborating with Program Lead
- Set up and maintain eTMF
- Ensures alignment of budget with protocol needs and responsible
for executing protocol within the budget
- Develops Site Monitoring Plan (SMP) with input from the
monitoring excellence group
- Manages Emergency Unblinding (EUB) Call Center activities
- Oversees all HQ close-out tasks
- Interface with External Data Coordination and Data
Management
- Responsible for creating and maintaining ADI logs
- Responsible for risk assessment, mitigation, planning and all
protocol plans
- Responsible for end of study reconciliation globally (clinical
& ancillary supplies)
- Responsible for quality control and inspection readiness at all
timesRequirements:
- BS/BA/MS/PhD with 7+ years of clinical research experience
- Minimum of 2 years of pharmaceutical experience as a lead SM/PM
required
- Global trial experience required
- Proven ability to meet aggressive timelines
- Excellent MS Excel and PowerPoint skills
- Excellent oral (including presentation) and written
communication, database management, and project management
skillsPreferred Experienced:
- MS Project experience
- TA experience Pay Range: $114,989 -$134,989/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.
Keywords: Labcorp Drug Development, Labcorp, Trenton , Senior Study Manager, Executive , Trenton, New Jersey
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