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Company Contact Info

  • San Diego, CA 92121
  • Tom Briscoe

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Clinical Data Manager

Ascent Life Sciences • San Diego, CA

Posted 5 days ago

Job Snapshot

Full-Time
Pharmaceutical, Biotechnology
Pharmaceutical, Biotech
2

Applicants

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Job Description

 Position Summary:

The Data Manager will assist in the coordination of data management activities from study start-up, data processing, and database close-out for RX and PK projects sponsored by Ignyta. 

Duties & Responsibilities:

Essential duties and responsibilities include the following. Other duties may be assigned.
  • Provide Clinical data management support to Clinical Operations team and Biostatistics team.
  • Participates in the review of Clinical research documents (eg. Protocols, CSRs, SAPs).
  • Development of study specific Data Management Plans (DMPs), ensure DMP is maintained throughout lifecycle of study project and ensures DMP is followed in accordance with study design and requirements.
  • CRO liaison for all DM activities
  • Development of study specific database (DB) clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic and data validations.
  • Participate in the development of Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs.
  • Reconcile electronic data transfers from vendor.
  • Development of test scripts and execution logs for User Acceptance Testing (UAT).
  • Conduct UAT of eCRF build and any programmed edit checks.
  • Perform ongoing reviews of data to ensure they are complete, consistent, and logical and work with the project team as applicable to resolve discrepancies.
  • Review data and queries for trends and assist with developing solutions to mitigate issues.
  • Assist in reconciling AE/SAE data in Safety DB and Data Management DB
  • Participate in conference calls and/or meetings with vendors.
  • Provide data management study metrics to internal team.
  • Oversee database lock process, ensuring compliance with SOPs/Guidelines
Education / Experience: 
  • B.S. or equivalent degree (life science preferred).
  • At least 3 years of relevant pharmaceutical, biotech, or CRO experience in clinical data management
  • Oncology study experience preferred.
  • eCTD submission prep experience.
  • Understanding of CDISC SDTM and CDASH standards.
  • Excellent organizational project management skills with great attention to detail and the ability to multitask.
  • Excellent verbal and written communication skills, as well as oral presentation abilities required.
  • Excellent interpersonal skills that would include dependability, reliability and credibility
  • Ability to work independently as well as collaboratively in a team environment, including liaising with multiple departments (e.g. Regulatory, Clinical Operations, Clinical Research, Pre-Clinical, BioStats).
Job ID: 17-10719
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