Sr. Manager Central Monitoring (RBQM)
Company: Labcorp
Location: Princeton
Posted on: January 27, 2023
Job Description:
- Manage portfolio of Customer studies and act as a customer
point of contact for the Central Monitoring activities
- Prepares and provides Central Monitoring (Site, subject & study
level review as applicable) proposal text and review of costing,
contributes to proposal strategy and development.
- Collaborates in the development of sponsor presentations/bid
defense support.
- Oversees at a study/customer level the appropriate tracking,
interpretation and application of data to proactively manage
risk
- Leads, plans, prepares, conducts and follows up the central
monitoring activities and supports less experienced team
members
- Plans and chairs detailed Risk Assessment meetings, oversees
preparation of initial Risk Management Register, and distribution
of Study Risk Impact Reports and assignment of Site Risk
Weighting.
- Ensures Critical Data & Process Definition are implemented in
EDC design by Data Expert
- Leads Site Risk Assessment across multiple studies, reviews
site outreach, Pre-Study Visit reports, Site Risk Assessment, site
risk stratification, advises on baseline site risk levels and
confirms appropriate initial site monitoring intervention levels,
aligned with monitoring strategy
- Develops and establishes requirements including prescriptive
risk factor mitigation strategies, SDV strategy, study-specific
risk factor definition, variable Risk Factor trigger levels.
- Reviews and approves the Central Monitoring plans and other
applicable plans and any subsequent changes.
- Ensures configuration of tools, risk factors trigger levels,
programming of study specific risk factors and central monitoring
parameters and coordinates user acceptance testing of tools
- Performs initial dashboard reviews, recommends adjustments as
required, supports and guides the team through ongoing reviews,
escalates critical study issues to appropriate stakeholders.
- Performs subject level and study level clinical reviews and
take appropriate actions as applicable
- Approves changes to monitoring levels, ensuring compliance with
applicable Plans and sponsor needs are met.
- Oversees Project Quality and Risk Reports to ensure client
satisfaction and compliance.
- Coaches assigned project teams internally and externally to
increase the central monitoring competence.
- Identifies and presents global strategic options and study
challenges/opportunities with the client during proposal, bid
defense and study implementation.
- Demonstrates visible leadership to clients through effective
problem solving and generation of customer solutions.
- Collaborates with other team members to assess the impact of
process improvements and either approve or refer upwards.
- Contributes to the development and maintenance of processes,
including SOP writing, process mapping and process improvements
using Six Sigma and LEAN methodologies.
- Any other duties assigned by supervisorQualifications:
- University / college degree or post-graduation (life science
preferred) from an appropriately accredited institution.
- Minimum of 8-10 years of relevant clinical research experience
in a pharmaceutical company/CRO or other equivalent experience with
increasing levels of responsibility in clinical trial related roles
e.g. project management, clinical monitoring, data management and
informatics.
- Experience in RBM (Risk Based Monitoring) or RBQM
preferred
- Good ability to work with/ to present to staff at all
levels
- Good influencing, negotiation and problem solving skills
- Good leadership and chairing skills
- Strong analytical skills, good detail focus and accuracy
- Strong planning, time management and organizational skills
- Strong project and risk management skillsLabcorp 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, Trenton , Sr. Manager Central Monitoring (RBQM), Executive , Princeton, New Jersey
Didn't find what you're looking for? Search again!
Loading more jobs...