Overview

We are a San Diego-based Recruiting company helping one of our best, also San Diego-based, Bio-Pharmaceutical clients, discover an experienced, talented and accomplished Sr. Clinical Database Associate.

The Senior Clinical Database Associate is responsible for independently performing data management tasks and providing oversight and leadership to support the development, design, implementation, and validation of clinical study databases for both in-house and outsourced clinical trials for all clinical studies/programs. From Them:

WHY WORK FOR US:

  • Explosive Growth
  • Well-Funded, publicly-traded company
  • Large pipeline, Several Drugs in last stage approval process
  • Excellent Pay + Bonus
  • Stock Options
  • 3 Weeks’ Vacation + Holiday Week Shut Down
  • Matching 401k
  • Amazing Benefits
  • Tuition Reimbursement
  • Super Healthy Company Culture

PRIMARY DUTIES AND RESPONSIBILITIES:

  • Oversee the development and quality control (QC) of data management documents including data management plans, data validation specifications, data management central files, and database quality control.
  • Represent Data Management as the Lead CDA on Clinical Project Teams.
  • Ensure that appropriate data validation (edit check) specifications, quality control checks, and any manual review procedures (eg, listing review) are implemented according to standard operating procedures (SOPs).
  • Develop Clinical Data Management timelines (with management approval) including interim and final database lock and data reviews; monitor overall data management tasks to ensure that timelines are met and that any issues are proactively identified and resolved.
  • Coordinate and assist with any in-house database design, validation, testing, and edit check programming to ensure that the clinical study database meets protocol and data specifications.
  • Identify, create, and utilize appropriate reports to ensure data validation and overall project timelines are met.
  • Identify, analyze, propose solutions, and effectively resolve complex data cleaning issues by exercising appropriate judgment and collaborating with the clinical project team members.
  • Coordinate and ensure completion of all aspects of data review, including running validation procedures, issuing queries, database QC, SAE Reconciliation, medical coding, and database closure activities according to SOPs.
  • Follows coding guidelines and utilize all available resources to accurately code, with minimal guidance, Medical History, Adverse Event, and Concomitant Medication data using MedDRA and WHO Drug dictionaries.
  • Provide data management guidance to the Biostatistics and Clinical Operations departments.
  • Create and provide input in the development of SOPs, Work Instructions, guidelines, standardization of case report forms and edit checks, and selection and implementation of data management software.
  • Develop and present at Investigator Meetings and train internal and external users (e.g., sites, CRAs) on the use of EDC.
  • Recommend improvements to existing Clinical Data Management practices and procedures (SOPs, Work Instructions), including identifying and recommending solutions for technology issues.

QUALIFICATIONS:

  • A minimum of 6 years of experience in an in-house bio-pharmaceutical clinical data management position is required
  • Bachelor’s degree in a scientific discipline
  • Comprehensive knowledge of data management practices from protocol design to database lock.  Proficiency with Medidata Rave; basic knowledge of SQL.
  • Experience working under Good Clinical Practices, Good Clinical Data Management Practices, CDISC/CDASH, and other FDA guidelines is required.
  • Proficiency with medical terminology and experience coding clinical data using WHO Drug and MedDRA coding dictionaries.
  • Must be able to travel up to 5% per year.
  • Bachelor’s degree in a scientific discipline
  • Additional experience utilizing Rave Architect, FrameMaker, and working at or with a CRO is a plus.

We look forward to speaking with you.