Clinical Data Manager – FSP

Data ScientistData ScientistFull TimeRemoteMid LevelTeam 10,001+Since 1983H1B SponsorCompany SiteLinkedIn

Location

Colombia

Posted

3 days ago

Salary

0

Seniority

Mid Level

Bachelor Degree2 yrs expEnglish

Job Description

Clinical Data Manager – FSP

Parexel

• Be able to lead a small clinical study or co-lead a larger study or studies with moderate guidance • Be able to support several clinical studies with minimal guidance • Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies • Review protocols for appropriate data capture including electronic Case Report Form (eCRF) design. Be able to perform a thoroughly detailed review of eCRF data requirements. • Interact with CRAs, programmers, study managers and statisticians in designing eCRFs and creating the annotated eCRF and CRF completion guidelines. • Develop data edit check specifications and run data listings as required • Coordinate the design and testing of Electronic Data Capture (EDC) systems according to company standards. Able to resolve EDC system issues with team members • Develop the Data Management Plan for a clinical study. Able to review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical analysis plans and vendor specifications • Enter data queries into the EDC system to be resolved at investigational sites and manage the resolution of those queries • Perform reconciliation of header data from external data sources against the clinical database • Perform Serious Adverse Event reconciliation activities according to SOPs and guidelines • Assist in database upgrades/migrations including performing User Acceptance Testing • Able to maintain study workbooks and data management files • Perform database lock and freeze activities per company SOPs • Participate in regular team meetings and provide input when appropriate • Provide input into the development of data management SOPs, Work Instructions, and process documents • Contribute to a professional working environment including the application of the client’s Code of Business Conduct and Ethics • Assist with the training of new employees and/or contractors

Job Requirements

  • At least two years’ experience in Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment
  • Understands the scope and focus of Phase 1-4 clinical studies, and has a proven ability to perform some of the core Data Management tasks and interact with vendors.
  • Possesses an understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidances, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice.
  • Experience and understanding of the Oncology or CNS therapeutic area and with Phase III pivotal studies are desirable.
  • Possesses strong English language written and verbal communication skills.

Benefits

  • Health insurance
  • 401(k) matching
  • Flexible work arrangements
  • Professional development opportunities

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