- TIME: Work with project team to set up and maintain project schedule. Update timelines within MS Project, CTMS, project governance tool, and other trackers. Escalate when timelines are at risk
- COST: Work with Project Lead to assist with TAQ/TAR (timesheet vs budget) reviews; vendor financial tracking & reconciliation; sponsor contract financial tracking & reconciliation; and final project financial reconciliation
- SCOPE: Work with Project Lead to conduct Contract vs Study Plan Review. Maintain tracker of out of scope (OOS) work performed. Assist the Project Lead to create Change Order Forms. Provide vendor management, escalating OOS activities to Project Lead.
- RISK: Update Xcellerate Risk Identification & Issue Resolution (RIIM) tool; and follow outstanding action items to resolution. Ensure Xcellerate Risk Assessment Categorization Tool (RACT) is complete, using Xcellerate Risk library. Work with Study Team to ensure Protocol Deviations are updated in Xcellerate RIIM
- QUALITY: Update Project Governance Tool on a monthly basis. Support the study team to identify, prevent and close quality compliance gaps. Support the Project Lead to prepare for audits and/or investigations, including creation of story boards to documenting issues that may occur during the study. Support study team to ensure timely closure of audit/inspection CAPAs
- TEAM COMMUNICATION: Facilitate study team communication & collaboration by attending & setting up team meetings; updating the ADI log; updating the Task Order Matrix; maintaining the Project Directory; setting up distribution lists, SP sites, mailboxes, and other collaboration tools; and set up / maintain project-specific trackers
- TEAM COLLABORATION: Collaborate with other support functions to facilitate timely TMF uploading, TMF reviews, TMF issue resolution, systems access, project-specific training curriculum, and other delegated tasks. Monitor for, escalate, and help to enforce redaction of subject sensitive information and identifiers in any study documentation
- LESSONS LEARNED: Work with Study Team to maintain Lessons Learned tracker
- OTHER: Performs other duties as requested by Line Manager, Project Lead, or other business leaders.
- University/college degree (life science preferred) or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution.
- In lieu of the above requirement, candidates with five (5) or more years of relevant clinical research experience in pharmaceutical, CRO industries or experience in a health care setting will be considered.
- 2-3 years of relevant industry experience
- Knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
- Computer competency with various programs (e.g., Microsoft Word, Excel, Project, Access and Power Point)
- Ability to develop accurate study related documents with minimal supervision
- Ability to communicate verbally and in writing
- Ability to mentor junior staff
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