Celerion

Clinical Data Manager

Celerion

full-time

Posted on:

Location Type: Hybrid

Location: Lincoln • New York • United States

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Job Level

Junior

Tech Stack

Google Cloud Platform

About the role

  • Oversight of all clinical data management activities for assigned studies in accordance with SOP’s and Procedure Guides
  • Primary Sponsor contact for data management processes on study
  • Responsible for regular communication of study progress with internal and external project team
  • Oversee CRFs from the creation of the blank CRF through delivery of final CRF to sponsor
  • Ensure database is set up per specifications and perform User Acceptance Testing (UAT) of clinical database
  • Coordinate creation of Data Management Plan, CRF Completion Guidelines, Data Validation Plan, and other study documents required per SOP and study needs
  • Manage clinical data cleaning and delivery activities up to and including database lock
  • Review clinical data to ensure accuracy, quality, and integrity of data
  • Generate, resolve, and track queries to address discrepant data identified during review
  • Perform third party data reconciliations
  • Coordinate data transfers (clinical data and vendor related data) with assigned Data Programmer and Sponsor contact
  • Proactively ensure on-time delivery of study deliverables through monitoring of study timeline commitments
  • Manage and appropriately handle/archive all CDM study materials (internally and sponsor specific)
  • Proactively assess project activities and identify issues and/or risk
  • Provide high level customer service to all internal and external clients
  • Perform Quality Control reviews on studies, as needed

Requirements

  • High School Diploma or GED, College degree strongly preferred
  • 1-2 years industry experience preferred
  • Knowledge of Good Clinical Data Management Practices, Medical Terminology, GCP, ICH Guidelines, and 21 CFR Part11 preferred
  • Knowledge of SAS preferred
  • Ability to manage multiple projects/priorities required
  • High attention to detail required
  • Excellent oral and written communication skills required
  • Excellent organizational skills required
  • Proficiency in MS office applications required
Benefits
  • Celerion Values: Integrity, Trust, Teamwork, Respect
  • Equal Opportunity Employer
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
User Acceptance Testingclinical data cleaningdata validationdata reconciliationSASGood Clinical Data Management PracticesMedical TerminologyGCPICH Guidelines21 CFR Part 11
Soft Skills
attention to detailoral communicationwritten communicationorganizational skillsproject managementcustomer serviceproblem-solvingrisk assessmenttime managementteam collaboration