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Clinical Data Manager

  • Location: San Diego
  • £ Salary: Negotiable per hour
  • Job Type:Contract

Posted over 1 year ago

  • Sector: Life Sciences
  • Contact: Taylor Cochran
  • Duration: 12 months
  • Start Date: 08/22/2022
  • Expiry Date: 12 September 2022
  • Job Ref: JN -082022-472977

Responsibilities:

* Lead Clinical Data Management operational activities in support of sample collection, reproducibility and/or clinical validation studies.
* Draft and perform data cleaning and review plans following Good Clinical Practices, (GCP), Good Clinical Data Management Practices (GCDMP) and CDM's work instructions and SOPs utilizing manual and automated processes.
* Accountable for drafting, education and upkeep of key project CDM deliverables (Data Management Plans, Data Transfer Agreements, etc.)
* Design and support study data workflows securely transferring and storing terabytes of diverse study data generated across multiple external sites.
* Responsible for Clinical Data Management Electronic Data Capture (EDC) development, validation and leading user acceptance testing.
* Primary point of contact across Clinical Affairs, Biostatistics, Product Test Groups, and Field Application Engineers for data queries and reconciliation
* Review and update overall study timeline deliverable dates in collaboration with Manager, Clinical Data Management

Skills and Qualifications:

* Bachelor's degree or above in a Biomedical, Life Science, or Engineering discipline preferred
* GCP, GCDMP and knowledge working in FDA regulated settings.
* Intermediate coding proficiency in EDC database development and SQL or other coding languages (SQL Server and or R preferred)
* Proficient in computer skills for communication and reporting (Microsoft Office, JIRA, Confluence)
* Strong collaboration skills with internal clinical personnel and external sites or vendors
* Knowledge of clinical/medical terminology
* Experience developing and leading user acceptance testing relevant to EDC deployment or other software release.

Experience:

* Minimum 4 years of relevant experience in Clinical Data Management in a Pharmaceutical, Biotech, CRO or similar environment.
* Experience leading multiple clinical study data management activities on standardized timelines
* Experience with clinical trial databases and electronic data capture (EDC) systems
* Experience with laboratory information management systems (LIMS)
* Working knowledge of FDA regulations, IVD GCP guidelines and other consortium-based standards (CDISC, GCDMP etc)
* Working experience and understanding of rare and/or reproductive health genetic diseases preferred.

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