Specific ResponsibilitiesSystem 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
- 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
- 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
Travel RequirementsThis 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 DutiesThis 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.