GRA Compliance Manager at Global/Biotech Cambridge, MA
Contract: 6 Months with possible extension or conversion
This contract role is responsible for the administration of the training program for GRA users of the Learning Management Systems (LMS - SABA and QUMAS). The contractor will provide administrative support and accountability for the LMS including reporting, learner inquiries/education on the LMS. The contractor will work with GRA Compliance staff to address customers' needs upon request, supporting continuing operations of the LMS systems to serve needs of the GRA organization.
Additionally, this contract role will support GRA Compliance activities
Assign training in learning management systems (LMS) specifically QUMAS and SABA identified by GRA compliance training team
??? Support internal and external partner requests to manage and transfer training material (multiple LMS systems being used during integration)
??? Run LMS reports as needed to support business requests and provide GRA with overdue training data upon request or schedule (based upon need/audits prep)
??? Support GRA QMS compliance mailbox, including triage requests, sending to appropriate GRA Compliance resources
??? Support integration initiatives and workstream activities from a training and documentation administration including curricula clean up.
??? Support the Technical Writing for the GRA SOP integration work streams.
??? GRA Compliance work to support LOC monitoring (confirm local label implementations, confirm local CMC changes, confirm local ASR submissions) and update of relevant systems for tracking LOC compliance (e.g. TRAIL, Submission Calendar, etc.)
??? Support the initiation, investigation, and closure of GRA Quality Events
Working hours: 8:30 PM - 5:30 PM
- Experience with LMS maintenance and reporting functionality (SABA and QUMAS preferred)
- Experience in partnering with internal and external stakeholders and staff to manage training data
- Experience using SABA and/or QUMAS from an administrative perspective
- Experience with Microsoft SharePoint (ability to create and administer preferred)
- Ability to multi task
- Good verbal and written communication skills
Experience within a regulatory/compliance life sciences organization
Expected outcome of contractor value: Contractor activities will be lifted and shifted from Manager GRA Compliance, and Associate Director GRA Compliance Training, allowing the team increased time to support organizational training needs, process and system integration activities, and the upcoming curricula and matrix modifications caused by pending integration workstreams.
Please contact firstname.lastname@example.org or 475-549-8806
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