cGxPServe
Sr. Clinical Data Manager
cGxPServe - Elk Grove Village, Illinois, us, 60009
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Overview
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Overview
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Sr. Clinical Data Manager
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cGxPServe 1 day ago Be among the first 25 applicants Join to apply for the
Sr. Clinical Data Manager
role at
cGxPServe Get AI-powered advice on this job and more exclusive features. Develop and maintain all data management documentation, including case report forms, data management plans, edit check specifications, data review plans and data transfer agreements. Design case report forms (CRFs) for electronic data capture (EDC) systems for data collection. Perform data entry and cleaning activities, including discrepancy management and query resolution. Conduct data validation checks and implement quality control measures to ensure accuracy and completeness. Collaborate with study team members to resolve data-related issues and discrepancies. Generate and review data listings, summaries and reports for data review Serve as a primary or backup resource for issues about data management. Ensure compliance with guidelines, Good Clinical Practice (GCP), CDISC standards and other relevant regulations. Contribute to the development and validation of data management software tools.
Responsibilities
Develop and maintain all data management documentation, including case report forms, data management plans, edit check specifications, data review plans and data transfer agreements. Design case report forms (CRFs) for electronic data capture (EDC) systems for data collection. Perform data entry and cleaning activities, including discrepancy management and query resolution. Conduct data validation checks and implement quality control measures to ensure accuracy and completeness. Collaborate with study team members to resolve data-related issues and discrepancies. Generate and review data listings, summaries and reports for data review Serve as a primary or backup resource for issues about data management. Ensure compliance with guidelines, Good Clinical Practice (GCP), CDISC standards and other relevant regulations. Contribute to the development and validation of data management software tools.
Requirements
BSc or MSc in Life Sciences, Data/Computer Science, Bioinformatics, or equivalent industry experience. 7 years of data management experience in the pharmaceutical or biotechnology industries. Strong expertise in project/program management including stakeholder management. Knowledge of industry standards (CDISC, SDTM, CDASH). In-depth understanding of Data Management regulatory guidelines: ICH, GCDMP, 21CFR Part 11 Proven ability to preemptively identify data and system issues and mitigate risks to data quality. Knowledge and experience with development, validation, execution, maintenance, documentation, and archival of clinical data. Experience in development and implementation of Clinical data management standards and procedures Experience with web-based EDC, clinical data management systems and medical coding dictionaries such as MedDRA and WHO Drug. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Research, Analyst, and Information Technology Industries Research Services Referrals increase your chances of interviewing at cGxPServe by 2x Sign in to set job alerts for “Senior Clinical Data Manager” roles.
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Sr. Clinical Data Manager
role at
cGxPServe 1 day ago Be among the first 25 applicants Join to apply for the
Sr. Clinical Data Manager
role at
cGxPServe Get AI-powered advice on this job and more exclusive features. Develop and maintain all data management documentation, including case report forms, data management plans, edit check specifications, data review plans and data transfer agreements. Design case report forms (CRFs) for electronic data capture (EDC) systems for data collection. Perform data entry and cleaning activities, including discrepancy management and query resolution. Conduct data validation checks and implement quality control measures to ensure accuracy and completeness. Collaborate with study team members to resolve data-related issues and discrepancies. Generate and review data listings, summaries and reports for data review Serve as a primary or backup resource for issues about data management. Ensure compliance with guidelines, Good Clinical Practice (GCP), CDISC standards and other relevant regulations. Contribute to the development and validation of data management software tools.
Responsibilities
Develop and maintain all data management documentation, including case report forms, data management plans, edit check specifications, data review plans and data transfer agreements. Design case report forms (CRFs) for electronic data capture (EDC) systems for data collection. Perform data entry and cleaning activities, including discrepancy management and query resolution. Conduct data validation checks and implement quality control measures to ensure accuracy and completeness. Collaborate with study team members to resolve data-related issues and discrepancies. Generate and review data listings, summaries and reports for data review Serve as a primary or backup resource for issues about data management. Ensure compliance with guidelines, Good Clinical Practice (GCP), CDISC standards and other relevant regulations. Contribute to the development and validation of data management software tools.
Requirements
BSc or MSc in Life Sciences, Data/Computer Science, Bioinformatics, or equivalent industry experience. 7 years of data management experience in the pharmaceutical or biotechnology industries. Strong expertise in project/program management including stakeholder management. Knowledge of industry standards (CDISC, SDTM, CDASH). In-depth understanding of Data Management regulatory guidelines: ICH, GCDMP, 21CFR Part 11 Proven ability to preemptively identify data and system issues and mitigate risks to data quality. Knowledge and experience with development, validation, execution, maintenance, documentation, and archival of clinical data. Experience in development and implementation of Clinical data management standards and procedures Experience with web-based EDC, clinical data management systems and medical coding dictionaries such as MedDRA and WHO Drug. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Research, Analyst, and Information Technology Industries Research Services Referrals increase your chances of interviewing at cGxPServe by 2x Sign in to set job alerts for “Senior Clinical Data Manager” roles.
Senior Manager, Clinical Data Systems (SDTM) - REMOTE
North Chicago, IL $121,000.00-$230,000.00 2 weeks ago Scientific Manager, COA Implementation, Patient Centered Solutions
Chicago, IL $95,300.00-$237,500.00 1 week ago Chicago, IL $90,000.00-$115,000.00 3 days ago Chicago, IL $43,888.00-$93,574.00 13 hours ago Chicago, IL $73,700.00-$78,000.00 3 days ago Senior Manager, Clinical Data Systems (SDTM) - REMOTE
Rosemont, IL $185,000.00-$260,000.00 1 week ago Senior Manager Clinical Service, Oncology Division
Chicago, IL $90,000.00-$100,000.00 1 week ago North Chicago, IL $82,500.00-$157,500.00 3 days ago Chicago, IL $95,000.00-$120,000.00 2 months ago Chicago, IL $80,336.75-$145,077.09 1 week ago Chicago, IL $68,300.00-$74,300.00 4 weeks ago Rosemont, IL $120,000.00-$140,000.00 3 weeks ago Chicago, IL $120,000.00-$140,000.00 3 weeks ago Chicago, IL $48,200.00-$48,200.00 2 months ago Chicago, IL $80,000.00-$120,000.00 1 week ago Project Manager, Clinical Hemostasis - TEMP
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr