Sr. Clinical Data Manager Job at cGxPServe, Dallas, TX

bkFMVThrNW5IR0xIQjhMOU1rTHlGN0ZRSUE9PQ==
  • cGxPServe
  • Dallas, TX

Job Description

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 pre-emptively 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.

Job Tags

Similar Jobs

U.S .Vision

Part Time Employed Optometrist Job at U.S .Vision

 ...with Dr. Sumjit Bajwa OD, PC is for a Part Time Employed Optometrist to provide coverage in our optometric office adjacent to our JCPENNEY Optical Department in our Lake Havasu City Arizona location! T he office is fully equipped and has a dedicated, professional... 

Saksoft

Java Full StackEngineer + Azure - Onsite - F2F Interview (Need IL candidates) Job at Saksoft

 ...Content ManagementStrong collaboration skills with vendors and internal Tec business teamsPreferred RecommendedExperience and skills with automated testing are strongly preferredExperience developing within an agile development environmentFamiliarity with Design Patterns... 

Contessa - Miami

Pizza Cook Job at Contessa - Miami

 ...Major Food Group ishiring Pizza Cooks to join our team at Contessa ! Contessa , inspired by the old-world resorts and the lasting estates of Italy, features cuisineembodying the effortless elegance of the Trattorias of Northern Italy. Offering all-day dining... 

Medical Services of America

Home Health Reimbursement Specialist (Lexington) Job at Medical Services of America

 ...Maverick of Money? Join our Corporate Team in Lexington, SC as a Home Health Reimbursement Specialist and put your financial...  ...required. Previous reimbursement experience. Previous medical office billing/collection experience. Whats in it for you? Dive... 

Greene Resources

Maintenance Technician Job at Greene Resources

 ...experience) Experience: 1-2 years of experience working in injection molding setup and processing. Education: High school diploma or equivalent...  ...this role, you provide technical support to help us produce plastic parts at a high standard of quality. In this role, you'll...