Sr. Clinical Data Associate

South San Francisco, CA


Contract Duration: 12-36 months


Rate: Negotiable


Salary: NA, $1.00

• Excellent employment opportunity for a Sr. Clinical Data Associate in the South San Francisco, CA area.
• Participates in the development, review and implementation of departmental SOPs, templates and processes
• May have project oversight of internal clinical data associates
• Provide feedback and task assignment
• Contributes to technical infrastructure of data management
• May participate in department or cross-functional initiatives
• Perform all data management tasks as appropriate including, but not to be limited to: data review and query management to ensure that quality standards are achieved.
• Perform reconciliation of the clinical database against safety data, laboratory data and other third party data as appropriate
• Review clinical trial data in accordance with Data Management Plans, Edit Check Specifications and/or Data Review Guidelines and raise queries to resolve erroneous, missing, incomplete or implausible data
• Generate, resolve and track queries to address problematic data identified during data review activities and apply proper modification/correction to the database as required
• Interact with other project team members to support the set-up, maintenance, and closure (e.g., Database Lock) of the Data Management aspects of the project and attend meetings as required
• Actively participate in eCRF Screen Review meetings
• Create, review, and/or execute Form and Edit Check Specification User Acceptance Testing by creating/reviewing dummy data to evaluate EDC database functionality
• Modify standard templates to create study specific Data Management Plans, or eCRF completion guidelines
• Assist in preparing Access Rights forms for EDC database
• Filing of Data Management documentation and data management related administrative tasks as requested, including maintenance of TMF as requested

• Bachelor degree in Life Sciences, Computer Sciences, Mathematics or health-related field preferred
• 4 years or greater relevant work experience in data management in a biotech, pharmaceutical setting, or CRO or experience as clinical data coordinator at a clinical site; depth and exposure to DM related tasks considered in lieu of minimum requirement
• Good understanding of pharmaceutical industry, clinical trial development/drug development and the role of DM
• Good working knowledge of ICH, FDA, and GCP regulations and guidelines
• Prior experience with detailed documentation processes