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Manager, Clinical Data Management in a CRO - Full Time REMOTE, some travel id-21067

Job Description / Summary

The Manager, Clinical Data Management is a full-time exempt position reporting to the Director, Clinical Data Management.

PLEASE NOTE: Candidates must have a valid Green Card or U.S. citizenship. No visa sponsorship is available now or in the future.

Must Have

  • 12+ years of hands-on data management experience.
  • 6-7 years of managerial experience, managing a team of at least 5 people.
  • 4+ years of experience in the CRO environment.
  • Excellent oral and written communication skills.
  • Ability to work in the PST time zone (flexible).
  • Willingness to travel 2-3 times a year when necessary.

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Responsibilities

  • Provide data management expertise to project teams, clients, and CROs, including study startup documents, data cleaning, DCF/query tracking, database QC, and SAE/AE reconciliation.
  • Oversee development of specifications for eCRFs/CRF, edit checks, electronic data handling, manual review, and User Acceptance Testing.
  • Conduct cross-functional data reviews, identify issues, and track resolutions.
  • Innovate and implement new technologies for process improvements.
  • Ensure adherence to quality control procedures.
  • Write and update SOPs/training guidelines.
  • Facilitate internal study team, client, and CRO meetings.
  • Review study data quality, provide metrics, and report out-of-scope activities.
  • Manage timelines and resources to meet deadlines.
  • Identify and recommend solutions for process inefficiencies.
  • Assist in preparing proposals and budgets for new and ongoing projects.
  • Direct and manage team members, including training, resource assignment, and performance reviews.


Education And Experience Requirements

  • 12 years of hands-on data management experience.
  • 6-7 years of managerial experience, managing a team of 5+ people.
  • B.S./B.A. in a science or technical discipline with 8 years of data management experience, or MS degree with 6 years of data management experience; minimum 4 years in the Pharmaceutical/Biotechnology industry or CRO environment.
  • Proficiency in SQL or SAS is desirable but not required.
  • Experience with various data collection and EDC systems.


Knowledge & Skills Requirements

  • Excellent oral and written communication skills.
  • Ability to work collaboratively in a multi-disciplinary environment.
  • Good knowledge of FDA, EMA, ICH guidelines, and GCPs, especially related to data handling and processing.


Salary And Benefits

  • Market rate compensation as base salary with all the benefits.
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