Principal Clinical Data Manager

2 weeks ago


Menlo Park, United States Clinvia LLC Full time

Responsibilities

Main point of client contact and study team for all DM related matters.

Execute all DM start-up activities, including the development and maintenance of eCRFs.

Define and create data listings, summary table validation, data specifications, and process data transfers for statistical review.

Ensure clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and final database lock.

Set and create the database and support the development of the study eCRF, validating them and assessing the correct functionality of the eCRF developed, in compliance with applicable quality validation standards.

Coordinate and execute the coding activities (using known dictionaries, e.g., MeDRA, WHO), drug safety reconciliation, and data review.

Reconcile Safety and Efficacy Data.

Qualifications

7+ years relevant data management experience in the CRO/pharmaceutical industry required.

EDC Designing and UAT experience is required.

Proven ability to use statistical software - SAS.

Demonstrates knowledge of GCPs and protocol.

Strong time management and prioritization skills to meet deadlines.

Strong project management and communication skills (verbal/written).

Experience in pharmacology and drugs life cycle.

Knowledge of ICH-GCP.

Strong analytic and quantitative background.

Excellent Microsoft Office skills.

Job Type: Contract

Pay: $80.00 - $95.00 per hour

Benefits:

  • 401(k)
  • Dental insurance
  • Health insurance
  • Vision insurance

Schedule:

  • 8 hour shift
  • Day shift
  • Monday to Friday

Ability to Relocate:

  • Menlo Park, CA: Relocate before starting work (Required)

Work Location: In person

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