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