Sr Manager, CCTrialSuite Administrator

| Winston-Salem, NC
Javara is seeking a Senior Manager of IT System Implementation and Clinical Research Operations who will be responsible for the overall administration of the Bio-Optronics CCTrialSuite implementation and ongoing administration.  This role will support the rapidly growing clinical operations initiatives conducted at our healthcare partners’ research sites.  This position reports to the Senior Director of Technology, Data & Analytics.

Position Type

This is a full-time, exempt position.

Essential Job Responsibilities

Promote the mission of Javara with a primary guiding principle of patient safety and well-being and building and maintaining a culture that combines the highest standard of integrity with excellence to all those Javara serves.

Specific Responsibilities

System Implementation
  • Support the overall implementation team with the transition to, and roll-out of the CCTrialSuite (CCCTMS & CCeSource) platform
  • Co-manage and optimize Javara business process definitions and workflow assessments
  • Manage CCCTMS configuration: site, organization, scheduling, staff, privileges and security
  • Manage Study Designers responsible for the CCeSource study design, builds and configuration
  • Support deployment planning and implementation activities
  • Support Change Management, including knowledge transfer and training development activities
  • Support the Quality Assurance team with Computer System Validation (CSV) and User Acceptance Testing (UAT) activities for initial implementation
  • Support data migration strategy and activities, as required
  • Support the phased system rollout activities
Clinical Technology Operations (Post Go-Live)
  • Provide overall system administration for on-going study builds, vendor support and enhancements
  • Manage the new user on-boarding process and role / privilege assignments, per Security Standard Operating Procedures
  • Work closely with the Quality Assurance and Operations teams to ensure new studies and major releases are validated per CSV SOPs
Security
  • Coordinates with the Security and Clinical Operations leads, ensuring all administrative and technical safeguards are in place at the study site level; and in compliance with HIPAA Security (45 CFR 164 Subpart C) regulations

Work Environment

Travel Requirements

This position requires minimal travel, on an as needed basis.

Required Education or Experience

  • 4-year college degree in a related field; Management of Information Systems (MIS) or Computer Science is preferred
  • Experience in the Life Sciences or Healthcare industries is strongly preferred
  • Excellent organizational and time-management skills, with significant experience managing multiple workstreams and cross-functional teams; formal project management experience is preferred
  • Experience supporting study sites; hands on experience with eClinical systems
  • Ability to navigate within a fast-paced, rapidly maturing environment
  • A team player that demonstrates strengths of integrity, accountability, ownership and analytical thinking

Other Duties

This job description covers the most essential functions of this position and is not designed to contain a comprehensive listing of activities, duties or responsibilities that are required of the employee in this job. Duties, responsibilities and activities may change at any time with or without notice.

Javara is an integrated research organization (IRO) that advances value by integrating clinical research within the healthcare ecosystem. Javara brings better outcomes for patient centered care, better economic results, improved access to cutting edge therapies and a more predictable research delivery model to the biopharmaceutical sector.

Equal Employment Opportunity Statement: Javara provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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