Clinical Database Specialist

Location
Hayward, CA, United States
Posted
Sep 18, 2019
Ref
834228361
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Summary:

The Clinical Database Specialist will collaboratively support other functional areas within Pulse and external vendors to ensure data collection are managed appropriately and organized accordingly in a quick and efficient timely manner. Manage all clinical site photos.

Essential Duties and Responsibilities:

This list of duties and responsibilities is not all inclusive and may be expanded to include other duties and responsibilities, as management may deem necessary from time to time.
  • Manage and maintain photo database
  • Create and run data reports on periodic basis
  • Expand and modify systems to better serve the needs of Pulse Biosciences
  • Develop programs and databases to assist clinical staff in accurately capturing and recording photos, documents, and reports from site visits
  • Consolidate data from multiple systems into a single archive
  • Handle projects through full data management study life cycle
  • Support project timelines and quality to determine resource needs and out of scope work
  • Conduct data management tasks for data review, writing and learning data clarifications
  • Review data, generate, and resolve data queries
  • Inform Clinical Data Manager on project status and potential problems regularly
  • Identify and comply with working instruction and core operating procedures
  • Handle external vendor application to ensure vendor quality service after initial setup
  • Support Clinical Data Manager in closeout activities such as audit and listing review
  • Support, mentor and train internal employees and clinical sites

Qualifications and Education:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • BA/BS required;
  • 2+ years of clinical data management experience
  • Experience working closely with vendors to make system changes as necessary
  • 2+ years' experience in clinical data management systems (e.g., DAM, ClinCapture, SimpleTrials);
  • Knowledge of CDISC/CDASH, GCMP and implementation of SDTM standards;
  • Knowledge of clinical research industry, biology, chemistry, toxicology, pharmacy, public health or related discipline;
  • Proficient in MS Office Suite

< close
Engineering