Experience:
No experience
Employment Type:
Full time
Posted:
1/16/2018
Job Category:
Information Services
Industry:
Other
Clinical Data Management (CDM) Systems Manager in Thousand Oaks, CA
(This job is no longer available)
Software Specialists | Thousand Oaks, CA
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Job Description

Clinical Data Management (CDM) Systems Manager

Location: Thousand Oaks, CA or San Francisco, CA

Job Description:

  • The Clinical Data Management (CDM) Systems Manager will work with cross-functional teams responsible for executing clinical trials, as well as, Interactive Voice/Web Response Systems (IVRS) supplier and Project Managers to support the design, implementation, and maintenance of outsourced IVRS systems. The role provides technical and project management oversight to ensure that the system designed for the study adheres to the study's protocol, industry regulations/best practices, and policies, procedures, and guidelines.

Responsibilities:

  • Lead and facilitate system requirements gathering meetings with clinical study teams and IVRS design PM
  • Design and oversee the development of study-specific IVRS technical documents
  • Document issues and risks, and implement mitigation plans in partnership with study team and vendor PM
  • Identify and track study-related technical issues to resolution
  • Closely manage project-related timelines and associated activities

Basic Requirements:

  • Doctorate Degree OR
  • Master's Degree & 3 years of Clinical experience OR
  • Bachelor's Degree & 5 years of Clinical experience OR
  • Associate's degree & 10 years of Clinical experience OR
  • High school diploma/GED & 12 years of Clinical experience

Preferred Requirements:

  • Bachelor's Degree in life science, computer science, engineering, business or related discipline
  • 4+ years of experience in clinical operations, clinical supply chain or clinical systems management
  • Experience implementing clinical systems, such as IVRS and eCOA
  • Working knowledge of Good Clinical Practices and FDA regulations governing clinical trial execution
  • PMP certification
  • Detail-oriented and able to manage many projects simultaneously
  • Excellent documentation and communication skills
  • Meeting management and facilitation skills
  • Vendor management experience
  • 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

Qualifications

Applicants must be eligible to work in the specified location

About Software Specialists

SCS, Inc. has for thirty years successfully provided a wide range of businesses with effective software solutions. SCS principals authored software which evolved into nationally recognized financial packages. SCS focuses on mid-range markets, but its expertise and support expands to multinational corporations, Fortune 500 companies and large government entities. SCS's President was elected President of the prestigious Software Council of Southern California in 1998, acknowledging decades of solid SCS accomplishment. SCS is the largest Navision Solution Center in the West US and is among the leading Solution Centers for Navision Software worldwide. We have implemented and customized Navision Software in over 350 companies in over 20 different industries.