Sr. Clinical Trial Specialist- Learning and Development Operations

NewAgeSys Inc. - Spring House, PA (30+ days ago)


POSITION SUMMARY:

Analyst, Clinical Trial Learning and Development Operations The Clinical Trial Learning and Development (CTL&D) organization will develop strategy and delivery of industry leading training for investigator site staff and sponsor staff participating in sponsored clinical trials. This includes material design, development, and maintenance, and will also include delivery of training materials via an on-line Learning Management System (eLMS) which result in shortened study start-up cycle times, increased learning effectiveness for conduct of clinical trial activities and overall improved site staff satisfaction. The CTL&D organization is a critical component to companies’ goal of becoming the Sponsor of Choice. The Analyst, CTL&D Operations will be an administrator/Training Manager of eLMS and the Clinical Trial Training Library. He/She will also , contribute to project work delivery, manage CTL&D metrics and compliance reporting. He/She will work with CTL&D TA Leads and ensure the necessary technical connections with Drug Dev and eBIS to ensure material is properly loaded into appropriate learning systems. He/She will also ensure maintenance of a fit for purpose training repository to ensure consistency among Therapeutic Areas and ability to re-purpose materials. 1. System Administrator/Training Manager, responsible for providing permissions to users, converting, loading, and testing content, for assigned Therapeutic Area Teams for Clinical Trial Training 2. Ensure training is appropriately assigned to investigator site staff within eLMS. Support study teams to ensure training is completed according to timelines and appropriately tracked 3. Responsible for coordination of timely notification of training assignments to site staff and sponsor staff as appropriate 4. Serves as the technical link between the trial teams, eBIS and LMS Vendors (ie Drug Dev, Bracket, etc) including technical LMS support and delivering applicable training as required. 5. Responsible for maintenance of the training library, relevant workflows, and permissions, enabling easy access for re-purposing existing content where appropriate 6. Manages content of training repository with appropriate mechanisms in place to support version control and compliance 7. Responsible for central management of materials in partnership with CTL&D TA Lead 8. Responsible for successful migration of legacy training processes for defined studies 9. Responsible for ensuring version control of training materials. 10. Contribute to lessons learned and overall continuous improvement 11. Supports oversight of operations process, tools and reporting and ensures necessary training/ support established 12. Support reporting of performance metrics per CTL&D agreed KPIs. Proactively identify issues to study team contacts and collaboratively develop solutions. 13. Contribute to capturing lessons learned / best practices 14. Responsible for championing the Clinical Trial Training process and providing help across the organization through development of administrative procedures and documents 15. Contribute to resource management data collection

QUALIFICATIONS :

EDUCATION AND EXPERIENCE REQUIREMENTS: Describe the minimum knowledge, skill and ability requirements for the position. Include any degrees or certifications which are required and/or desirable. * Bachelor degree is required. * At least 4-6 years of experience required * Minimum 3 years of experience with a Learning Management System * Relevant experience associated with global clinical trials operations is preferred * Knowledge of document Archiving with exposure to a regulated industry (i.e. Pharmaceutical, Telecommunication, Government, etc.) is required * Demonstrated proficiency in using enterprise business systems, processes and workflows is required * Strong communicatioskills are required. * Strong Technical Troubleshooting skills are required * A proven track record of working cross functionally with different levels within the organization is required. * Must have experience working with both internal and external customers to correct technical difficulties * Must be customer focused and have the ability to interact with our Clinical Trial Investigators and their staff. * Must be proactive, and willing to challenge the status quo. * Knowledge of continuous improvement tools and application to business process are a plus * Experience working in a global environment * Ability to organize and manage workload and work independently * High quality work attitude with the needed focus on details and appearance Experience of working in a multi-cultural environment.

Job Type: Contract

Experience:

  • Clinical Trial: 4 years
  • Learning Management System: 4 years

Education:

  • Bachelor's