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Job description
South San Francisco, CA
Contract Duration: 12-36 months
Rate: Negotiable
Salary: NA, $1.00
Responsibilities:
Excellent employment opportunity for a Specialist Clinical Development in the South San Francisco, CA area.
Participates in the development, review and implementation of departmental SOPs, templates and processes
Support budget and resource planning across assigned projects
Contribute to technical infrastructure of data management
Participate in CRO/vendor selection process for outsourced activities
Represents data management in study team meetings
Manages data management timelines to coordinate and synchronize deliverables with the overall study timelines
Generates and/or reviews/approves study documents (e.g. Data Management Plans, Case Report Forms, data transfer specifications, SAE and/or external data reconciliation plans, coding conventions, study protocols)
Executes and/or distributes data management metrics, listings, and reports, as required
Oversight of data management CRO/service providers on assigned studies
Monitors the progress of all data management activities on assigned studies to ensure project timelines are met
Provides training on the CRF completion guidelines and EDC system at Investigator meetings and to internal or external team members, as needed
Proactively identifies potential study issues/risks and recommends/implements solutions
Responsible for the accuracy and completeness of the clinical data collected during a clinical trial, able to work independently towards the assigned goal
Provide DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables
Experience: Bachelor degree in Life Sciences, Computer Sciences, Mathematics, or health-related field
Minimum of 5 years of SENIOR-LEVEL DM (i.e., Sr. CDA) experience in the pharmaceutical or biotechnology industry or equivalent; depth and exposure to DM related tasks considered in lieu of minimum requirement
CRO management experience desired
Competence in SAS programming a plus
Prior oncology/hematology experience highly desirable
Requires solid knowledge of clinical data management principles, clinical trials process and regulatory requirements
Excellent verbal/written and interpersonal skills required
Able to communicate and collaborate effectively with cross-functional teams in face-to-face conversation, by telephone, and by email
Worksite address
south san francisco, CA, 94083, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.