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2 days old

Manager, Clinical Data Management

Kelly Services
Raleigh, NC 27608
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 SUMMARY**


The 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 FUNCTIONS**


+ 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 manner.

+ 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 trends.

+ 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 existing processes.

+ Manage day-to-day activities of junior data management staff as needed.

+ 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 processes.


**EDUCATION/EXPERIENCE REQUIREMENTS**


+ Bachelors 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 interestsits 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, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were 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 Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-02-22 Expires: 2021-03-25

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Manager, Clinical Data Management

Kelly Services
Raleigh, NC 27608

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