Sr. Clinical Data Associate

Seattle Genetics   •  

Bothell, WA

Industry: Pharmaceuticals & Biotech

  •  

8 - 10 years

Posted 66 days ago

This job is no longer available.

Description


Summary:

The Sr. Clinical Data Associate (CDA) is capable of leading Data Management aspects of a clinical study with minimal support and oversight. The Sr. CDA has thorough knowledge of FDA regulations and industry standards, strong technical skills, and is capable of leading infrastructure assessment and improvement.

Responsibilities:

  • Independently develop DM documents including but not limited to DMPs, CRFs, CRF Completion Guidelines, Edit Checks, UAT specifications, centralized monitoring plans, data flow and integrity plans, blinding plans, and data review plans
  • DM Project Management: Understands critical tasks and milestones; ensures data management deliverables are met per study timelines. Utilizes experience and appropriate tools to efficiently lead and coordinate data management activities. Ensure study team members understand and deliver components affecting data to ensure successful execution of deliverables. Provide solutions for data management issues that arise during study conduct
  • Manage/coordinate work performed by vendors/CROs as appropriate to ensure quality of product. Assist in the selection of vendors/CROs (e.g. review RFPs, attend site audits)
  • Ability to run SAS programs, review SAS logs, and generate output. Program SAS Non System Edit Checks (NSECs) and/or SAS Data Listings as appropriate for SAS skill level. Mentor less proficient SAS users as appropriate
  • Independently lead data cleaning activities such as but not limited to Study Team data reviews, Non-system Edit Check Output review, SAE reconciliation, and non-CRF data reconciliation
  • Independently manage the database lock process in an efficient and timely manner
  • Evaluate CDM processes and applications for improvements; participate in working groups to develop and implement new processes and applications
  • Coordinate and delegate work performed by junior CDAs, as needed; assist in mentoring of junior CDAs and/or contractors
  • Utilizes experience and leadership skills to provide guidance to other team members. Takes ownership of process resources available to team

Requirements:

  • BA/BS in relevant field and 8+ years experience. Years of experience may substitute for education
  • Requires effective organizational and communication skills
  • Technologically savvy; quickly picks-up new information, standards, regulations, tools, methods or software as it relates to position and profession
  • Detail oriented; performs quality and accurate work
  • Thorough knowledge of FDA regulations, ICH GCP guidelines, SDTM, CDISC, database development, UAT, medical coding, the drug development process
  • Knowledge and understanding of DM Lifecycle associated with P1-P3 studies, including pivotal, blinded, and randomized trials
  • Previous relevant EDC experience required
  • Previous vendor/CRO management required

Preferred:

  • Previous experience with RTSM/IWRS and ePRO systems
  • Database development experience
  • SAS programming experience
  • Oncology experience