Clinical Data Manager II

Company : Katalyst Healthcares & Life Sciences

Country: United States

Location : Mansfield, Massachusetts

Post: Thu, 23 Mar 2023 06:34:21 GMT

Expires: Thu, 20 Apr 2023 23:59:59 GMT

Apply Job : Apply Online

—————————— Job Description ——————————

Responsibilities:

Provide EDC Services for projects including Protocol Conversion, Database Build, eCRF design, Edit Checks design and related EDC component s

Provide Data Management Services for projects including Data Verification, Data Review, Query Management, Coding, External Data Reconciliation, SAE Reconciliation and related tasks

Collaborate with the project team to ensure the deliverables are completed on time with high quality

Provide Quality Control on deliverables developed by other team members including Review Report specifications and Clinical Data Repository (CDR) deliverables

Maintain or provide input to all required Study Documents including Data Validation Specifications, Data Management Plan as required by SOP and Processes

Work on consulting efforts related to systems including UAT, global library and standards development, implementation of Client CDRs

Ensure compliance with clinical Solutions and industry quality standards, regulations, guidelines, and procedures

Other duties as assigned

Requirements:

Bachelor of Science degree in health-related field ; Master’s in science preferred

6+ years’ experience in Clinical Data Management or equivalent preferred

Minimum 2+ years in Pharmaceutical and/or Biotechnology industry or equivalent consulting role preferred

Strong knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology

Experience performing data management activities, EDC experience a plus

Detail oriented, ability to multitask with strong prioritization, planning and organization skills

Proficiency in Microsoft Office Applications

Strong familiarity with EDC and Clinical Data Management Systems: Rave, Inform,CLIN trial, or Oracle Clinical preferred

Experience with Data Reporting Tools: Business Objects, Review, Cognos or related preferred