Senior Clinical Data Manager in San Diego, CA

$100K - $150K(Ladders Estimates)

ACADIA Pharmaceuticals   •  

San Diego, CA 92101

Industry: Pharmaceuticals & Biotech

  •  

8 - 10 years

Posted 34 days ago

As part of the Data Management (DM) team, responsible for study-specific data management activities, including study set up, maintenance, data review, and database closure.

Primary Responsibilities:

  • Reviews protocols and provides input relevant to data management issues.
  • Oversees/leads all data management activities for clinical studies either directly or overseeing a Clinical Research Organization (CRO).
  • Manages DM study activities with vendors, including external labs (transfer specifications and timelines) and Electronic Data Capture (EDC) vendor (DB build, User Acceptance Testing (UAT), maintenance, and lock)
  • Collaborates with other departments on clinical study start up (e.g. case report form (CRF) design), clean up, and closeout.
  • Responsible for study-specific DM documentation including the Data Management Plan, database creation/validation including edit checks, and query generation/resolution.
  • Responsible for clinical study data maintenance, data listings, entering queries, reviewing query resolutions, etc.
  • Provides input on general data management documents such as SOPs and CRF templates.

Education/Experience:

BA/BS in Life Sciences or equivalent combination of relevant education and applicable job experience.

Minimum 8 years of experience in clinical data management.

Must possess:

  • Hands on training and experience in clinical trial methodology and Good Clinical Practice.
  • Excellent understanding of all aspects involved in the data management responsibilities throughout a clinical trial.
  • Experience with Medidata's Rave system including strong J-Review skills.
  • Proficient organizational and documentation skills.
  • Excellent written and verbal communication skills.
  • Strong understanding of regulatory guidance and regulations (eg. International Conference on Harmonisation (ICH), 21CFR Part 11, etc.).
  • Strong understanding of CDISC and CDASH standards.
  • Must be a team player who works effectively with other disciplines.


Valid Through: 2019-10-9