Manager – Clinical Data Management Operations
Confirmed live in the last 24 hours
Arrowhead Pharmaceuticals
Pasadena, CA, USA • San Diego, CA, USA
Experience Level
Desired Skills
Operations & Logistics
  • Bachelor's degree
  • Minimum of 5 years of experience in a fast-paced pharmaceutical/biotechnology position facilitating execution of multiple proof of concept, late stage and post-marketing trials simultaneously
  • Commitment to quality programs and data-driven program evaluation
  • Excellent interpersonal (multidisciplinary), written and verbal communication skills
  • Ability to communicate technical information to a non-technical audience
  • Working understanding of GCP standards, CDISC standards (CDASH, SDTM, ADaM), FDA and ICH guidelines, and recommended CDM Best Practices
  • Excellent understanding of the clinical trial database life cycle including CRF design, database development and testing, discrepancy management, data quality review and database close and lock procedures
  • Knowledge of CDISC standards, specifically SDTM datasets/SDTM mapping
  • Thorough knowledge of drug development process from IND to NDA
  • Good understanding of database and dictionary structures (e.g., MedDRA)
  • Established experience with EDC vendors and processes
  • Master's degree
  • Supervisory experience
  • Medidata Rave experience
  • Expertise in Spotfire or other programming tools
  • The Manager, Clinical Data Management Operations, leads the data management components of a clinical trial ranging from small early phase to large global and late phase programs. The assigned clinical trial(s) may be high complexity or high risk. The position is accountable for ensuring study launch, conduct, and closeout are performed according to quality standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and International Conference on Harmonization (ICH) guidelines to fulfill all federal and local regulations. Duties include serving as the primary data management liaison with vendors and senior management
  • Responsibilities