Clinical Data Manager

Location
Redwood City, CA, United States
Posted
Jan 17, 2019
Ref
1-193
Discipline
Clinical, Clinical Data
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
This position is responsible for management and/or oversight of data management activities for clinical trials conducted by Emergent or outsourced to a vendor. Works closely with upstream and downstream functional groups such as Clinical, Regulatory, IT, Statistical Programming and Biostatistics.

We offer a flexible schedule and work from home capability as arranged with your Manager. We are committed to providing development and training, including opportunities to stay current with new industry guidelines and best practices. At Emergent, employees contribute meaningfully to the health and welfare of individuals around the world, and can use paid time to volunteer for an organization of their choice.

Responsibilities:
  • Electronic Case Report Form (eCRF) design using CDISC guidelines
  • Specification of Electronic Data Capture (EDC) build
  • EDC database review and quality control (UAT of eCRFs, visit structure, edit checks, implementation of randomization scheme, compliance with the protocol)
  • Review of EDC data for completeness and correctness, querying of sites for correction and resolving queries when answered, identification of potential problems, issues, or trends and escalation within Clinical as necessary, and reconciliation of external data (such as laboratory data, Serious Adverse Event/Events of Interest information, or, if needed, independent review by medical personnel) with EDC data
  • Ability to use, develop, and/or implement data views for optimal and efficient review of large quantities of data and programming these reports in SAS
  • Review of CDISC SDTM conformance reports to identify data conformance issues that need Data Management action
  • Development of external data specifications (such as laboratory or EKG data specifications)
  • Participate in developing internal documentation and infrastructure such as SOPs and data management document templates to support in-house Data Management activities
  • Creation, review and oversight of documents such as Data Management Plans, eCRF completion guidelines, and source documents for completeness and consistency
  • Provide progress reports of activities to head of Data Management
  • Ensure Data Management documentation is appropriately filed in the electronic Trial Master File
  • Provide other support to Clinical or Data Management as needed

Qualifications:
  • At least 2 years performing the stated data management responsibilities in the pharmaceutical industry
  • Base SAS programming
  • CDASH and SDTM familiarity
  • Ability to work independently, self-directed, as well as collaboratively in a team
  • Excellent organizational skills and ability to prioritize tasks, with mentorship
  • Effective communicator, both oral and written.
  • Demonstrated ability to communicate with non-data focused people a must.
  • BS degree or equivalent