Manager, Clinical Data Management
Company: Kelly Services
Posted on: April 10, 2021
We develop novel combinations of cell therapies, vaccines and
antibody immunotherapies for oncology and infectious
diseases.--Manager, Clinical Data Management--(Can start working
remotely but must be on site 3 days a week after Covid)--POSITION
SUMMARYThe Manager, Clinical Data Management is an expert in
clinical data management with demonstrated capability in building
and maintaining clinical trial databases.-- They contribute to
process improvements and initiatives within the Biometrics
department and are expected to manage direct reports.--ESSENTIAL
- Create and/or review study-specific electronic or paper Case
Report Forms (CRFs) using prior knowledge, protocol specific
information and departmental standards.-- Work efficiently to
incorporate core clinical team input and produce CRFs in a timely
- Configure, migrate, and test electronic data capture (EDC)
databases based on internal procedures, study requirements and
system best practices.-- Serve as database manager for the study
specific clinical team, including compilation of edit checks.
- Develop database requirements for use by EDC vendors.-- Serve
as study database manager and work with vendors to obtain
deliverables in a timely manner.
- Create and/or review study-specific data management and
database documentation, which may include:
- Data Management Plan
- CRF Completion Guidelines
- Coding Guidelines
- Annotated CRFs
- Edit Check Specifications
- Attend study-specific team meetings and produce status reports
and requested metrics, which may include query information or data
- Perform data review and query generation/closure.
- Perform coding of verbatim terms such as adverse events and
concomitant medications.-- Collaborate with medical scientists for
coding, consistency, review and approval.-- Incorporating coding
file into clinical database.
- Participate in development of new processes or revision of
- Manage day-to-day activities of junior data management staff as
- Train Investigators and/or Study Coordinators at Investigator
Meeting on the CRFs, the EDC system, and the CRF completion
guidelines as needed.
- Provide data management expertise and support to the clinical
teams using data management best practices.
- Provide analytical insight on data management strategies and
advise internal team with tactical strategies accordingly.
- Train junior staff in more complex clinical data management
- Bachelor's Degree in a science-related field.
- 6+ years of clinical data management experience.--REQUIRED
COMPETENCIES - KNOWLEDGE, SKILLS, ABILITIES
- Working knowledge of the clinical research, Good Clinical
Practices, and regulatory requirements/guidelines.
- Experience working with EDC clinical databases.
- MedDRA and Who Drug coding experience.
- Knowledge of CDISC/STDM standards.
- Excellent English verbal and written communication skills; good
organizational and interpersonal skills.Why Kelly--?Kelly Science &
Clinical is your connection to premier scientific and clinical
companies looking to hire talented people just like you. Every day,
we match science professionals with dream jobs that fit their
skills and interests-it's the way we think job searching should be.
Nearly 100 percent of our science recruiters have a professional
background/education in science, so we know a thing or two about
the science market and how to get you noticed.About Kelly--At
Kelly, we're always thinking about what's next and advising job
seekers on new ways of working to reach their full potential. In
fact, we're a leading advocate for temporary/nontraditional
workstyles, because we believe they allow flexibility and
tremendous growth opportunities that enable a better way to work
and live. Connecting great people with great companies is what we
do best, and our employment opportunities span a wide variety of
workstyles, skill levels, and industries around the world. Kelly is
an equal opportunity employer committed to employing a diverse
workforce, including, but not limited to, minorities, females,
individuals with disabilities, protected veterans, sexual
orientation, gender identity. Equal Employment Opportunity is The
Keywords: Kelly Services, Raleigh , Manager, Clinical Data Management, Executive , Raleigh, North Carolina
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