Specialist Clinical Development

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