Sr. Clinical Data Specialist (AdvancedGroup_415196) Fremont, California

Salary: USD50 - USD55 per hour + Will convert to perm

Job Number: 415196

Sr. Clinical Data Specialist

General Summary:

This position is responsible for providing data management support on clinical trials and for ensuring that clinical data management activities are conducted in accordance with regulatory and company standards.

 

Duties and Responsibilities:

Under minimal supervision perform the following duties:

  • Review and provide input from data management perspective on protocols.
  • Work in conjunction with Clinical Project Manager on CRF design process utilizing data form standards.
  • In collaboration with Clinical, create CRF completion guidelines to be utilized by sites and clinical research associates.
  • Work with Database Programmer Analysts to set up, validate and maintain clinical databases in accordance with company’s standards.
  • Work with Database Programmer Analysts to develop edit checks.
  • Perform user acceptance testing (UAT) of database.
  • Manage access to the database by completing access revocation request forms and forwarding them to appropriate database personnel.
  • Prepare and present CRF and CRF completion guidelines at investigator meetings.
  • Ensure quality data management activities – i.e., data review, query generation and resolution, generate status reports to clinical staff and management.
  • Ensure that Data Coordinators complete entry in a timely fashion.
  • Create and maintain Data Management Plans, including, but not limited to: CRF/DCF flow, external data handling, SAE processing, coding, lock procedures, and archival procedures, collaborating with Clinical.
  • Create and maintain tools for tracking and inventory of CRFs and DCFs.
  • Develop guidelines for data entry.
  • Generate queries to resolve data issues and apply corrections to database, working with the clinical research associate.
  • Perform reconciliation of adverse events with serious adverse events database according to established guidelines.
  • Perform coding of medical data using industry standard dictionaries such as MedDRA, WHO Drug, etc.
  • Process laboratory data, including laboratory normal reference ranges, from local, central, or external labs according to established guidelines.
  • Understand the fundamentals of merging external data with the CRF data.
  • Work with Database Programmer Analyst to initiate database lock procedures with approval from the Clinical Project Manager.
  • Coordinate and perform or oversee database quality control audit prior to database lock.
  • Review final tables, listings, graphs, reports, and narratives produced by Biostatistics.
  • Perform or oversee final archival of CRFs/DCFs database.
  • Act as a point person and provide oversight for CRA data management activities.

 

Minimum Education & Experience:

  • Bachelor's level degree or equivalent in health/science related field.
  • The ideal candidate will have 5-7 years of experience in clinical data management; preferably 3 year in device or pharmaceutical clinical trials.
  • Strong computer skills including EDC is required.
  • Familiarity with clinical trial design and analysis issues.