Clinical Data Manager II
Quick Apply Contract 7 hours ago Full 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 Quick Apply.
Estimated Salary: $20 to $28 per hour based on qualifications.
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 Quick Apply.
Estimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
