Senior Manager, Clinical Data Management to Senior Clinical Data Manager

Location
Brisbane, CA
Posted
Jun 07, 2018
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Summary

The Senior Clinical Data Manager (Sr. CDM) will be primarily responsible for quality review and data cleaning of clinical trials.

Specific Responsibilities:

  • Conducting and supporting data reviews
  • Submitting queries to vendors
  • Follow up on query resolution
  • Development of data validation specifications and collaboration with clinical programmers to program specifications
  • Assist in review and approval of vendor data management documentation, such as CCGs, Data Management Plans, and Data Validation Plans

Qualifications / Requirements:

  • Bachelor’s degree in a related scientific field and at least 10 years’ data management experience
  • Demonstrated ability and experience overseeing external vendors

Preferred Experience, Special Skills, Knowledge:

  • Knowledge and experience with various clinical databases and key technologies (e.g., EDC, CTMS, IVRS/IWRS, CDISC)
  • Working knowledge of GCP, ICH, FDA, and regulatory guidelines
  • Excellent verbal communication, writing and interpersonal skills
  • Self-sufficient and able to work with minimal oversight

About Aimmune Therapeutics, Inc.

Aimmune Therapeutics is a clinical-stage biopharmaceutical company founded to address the unmet medical need in food allergy, which currently has no approved treatments. Our mission is to improve the lives of people with food allergies, based on our proprietary desensitization treatments in development. Aimmune’s lead investigational drug for peanut allergy, AR101, is in Phase 3 clinical testing in North America and Europe. Headquartered in the heart of San Francisco’s biotechnology hub, Brisbane, California, Aimmune has additional offices in the Kings Cross area of London, and in Raleigh, North Carolina. 

Qualified candidates should forward a resume and cover letter, including a statement of interest, availability, and experience to Human Resources with the job title in the subject line.

Aimmune Therapeutics is an Equal Opportunity Employer.

Principals only; no recruiters please.