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CDM Systems Manager

Thousand Oaks, CA
Top 3 Must Have Skill Sets:
    
Negotiation with external vendors, management of people and projects, familiarity with documentation in a regulated environment

Description:

*IRT - Interactive response technologies and/or eCOA - electronic Clinical Outcomes Assessment
*Pharma or Biotech or supplier experience required
*Must have vendor or supplier monitoring / auditing experience
*Candidate will be working remote - Ideally PST - open to US Time Zone

The CDM Systems Manager will work with a cross-functional team of internal stakeholders (including, but not limited to Quality, Supplier Governance, eCOA functions) and technology suppliers to ensure the quality of system-related processes and integrity of data at those IRT and eCOA suppliers for sponsored clinical trials. The CDM Systems Manager will monitor the compliance of IRT and eCOA suppliers to ensure that their computerized systems and processes adhere to industry regulations / best practices as well as company policies, procedures and guidelines.

Responsibilities:
• Consult on the annual systems monitoring schedule based on determination of system-related risks
• Plan and conduct systems monitoring visits
• Identify issues related to supplier computerized systems and related processes
• Develop Monitoring Debrief and Visit Reports for distribution to supplier and internal stakeholders
• Follow up on identified systems issues and escalate as appropriate
• Review corrective and preventative actions for identified systems issues and audit findings, as appropriate
• Participate in supplier governance meetings as needed
• Increase technical proficiency by exploring new training opportunities and staying current with new technologies and the changing regulatory environment
• Develop systems monitoring-related training materials and tools
• Consult internal staff in area of systems monitoring

Basic Qualifications:
Doctorate degree & 1 year of directly related experience
OR
Master’s degree & 3 years of directly related experience
OR
Bachelor’s degree & 5 years of directly related experience
OR
Associate’s degree & 10 years of directly related experience
OR
High school diploma / GED & 12 years of directly related experience

Preferred Qualifications:
Bachelor’s Degree in life science, computer science, engineering, business or related discipline
Experience implementing clinical systems, such as IRT and eCOA
Work experience in information systems monitoring, quality assurance and/or auditing
Experience at, or oversight of, clinical research vendors (CRO’s, central labs, imaging vendors, etc)
Working knowledge of Good Clinical Practices and FDA regulations governing clinical trial execution

Key Competencies:
Detail-oriented and able to manage many projects simultaneously
Excellent documentation and communication skills
Meeting management and facilitation skills
Excellent time management and organization skills in a timeline-driven environment
Sound problem resolution, judgment, and decision-making abilities
Work well in a team-based environment with minimal supervision

"This posting is for Contingent Worker, not an FTE"

 

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