Senior Manager, Clinical Operations Training

Manages all aspects of training (i.e., training needs assessment, development, implementation, assessment, etc.) within the Clinical Development Operations Organization; May serve as Training Lead for Clinical Development Operations technology initiatives and Medical Division initiatives. Manages the implementation and continuous improvement of Clinical Development Operations Organization new hire on boarding programs and activities.DUTIES & RESPONSIBILITIESDuties and Responsibilities:

- Assesses, designs, develops, implements and manages all training related activities and materials for the Clinical Development Operations Organization. Maintains training repository of materials.
- Works with Clinical Development Operations Groups to identify training needs and topics in need of training materials (e.g., eLMs, slides, job aids, tip sheets, instructor-led training, etc.).
- Assist with documentation and close out of deviations and CAPAs and implement training mechanisms to make appropriate stakeholders aware of deviations and CAPAs; Follows up with resources assigned actions in deviations and CAPAs to ensure on time completion and close-out.
Drives process improvement and creation for Clin Dev Ops processes and procedures and the associated education of process/procedures.
- Partners with Clin Dev Ops Compliance Role to conduct ongoing assessment of audit trends and implement remediation activities across the department
- Represent PM&T Group on Department and/or Medical Division projects and initiatives (e.g., SOP/WP revisions, Vendor Management Training, Clinical Project Management Training, Training Standards Project, Technology Initiatives, Mentoring, etc.).
- Ensures that training materials have appropriate cross-functional support, input and review.
- Delivers training as appropriate.
- Leads the Clinical Development Operations Organization new hire on boarding activities and programs. Orient Clinical Development Operations new hires to on-boarding process. Serve as point person for new hires for on-boarding and training. Ensure on-boarding activities/milestones are completed for each new hire.QUALIFICATIONSQualifications:

Experience:
BS degree with 7+ years clinical trial operations/execution experience, 2+ years experience in a role with training development, implementation; including assessment and management of training needs

Other:

- Solid understanding of GCP, ICH and the clinical development process