Global Site Management Specialist

As a Specialist, Global Site Management (GSM) you work closely with the GSM Regional Heads, Clinical Trial Liaison and the Monitoring Strategy and Oversight teams. The role reports to a Regional Head GSM and supports the function in all aspects of clinical trial delivery, tracking, and metrics and reporting, including organizing departmental meetings and supporting process improvement initiatives as appropriate. Specifically, the Specialist, GSM is responsible for supporting the Clinical Trial Liaison (CTL) team with country and regional site management, including feasibility support, issue management tracking and the analysis of performance and operational data. In addition, the Specialist GSM works closely with the Monitoring Strategy and Oversight team supporting the Monitoring Oversight business process and monitoring plan/monitoring strategy creation and tracking, including representing GSM during relevant external interactions with vendors and CRO partners.

This individual is expected to represent GSM in cross functional group meetings and forums in partnership with other Global Clinical Trial Services (GCTS) functions and Clinical Trial Management (CTM). The Specialist is responsible for all aspects of role onboarding, functional document inventory management and maintenance of the functional share-point site and Academy sites. It is expected that the individual is trained in all aspects of ICH-GCP and relevant local operational and regulatory requirements.

• Serves as Co-chair of Regional CTL Meetings


• Responsible for and acts as the custodian of the GSM Sharepoint and Academy Pages


• Responsible for Staff Onboarding (includes role-based training assignments, system accesses etc)


• Performs site management activities, when delegated, to ensure compliance to the protocol, monitoring plan, ICH GCP, REGN SOPs, and local operational and regulatory requirements.


• Partners in-country/region with study assigned Clinical Trial Liaison (CTL) to optimize clinical trial deliverables.


• Partners with other REGN roles and functions (eg. SB&C, SSU, CTM, GTO) to support site feasibility, activation, enrolment, close out and issue management.


• Provides metrics and data in support of International Medical Affairs and GSM in-country reviews


• Tracks monitoring strategies and monitoring plan versions.


• Supports the Oversight Monitoring business process (reviews, actions, and outcomes)


• Provides project support for Next Generation Monitoring (NGM)


• Represents GSM during applicable internal and external stakeholder meetings (CRO KO meetings, feasibility KO meetings, FSP vendor meetings, issue management and deep dives)


• Maintains functional metrics repositories (eg Qliksense) and generates reports as required


• Tracks and reports to GSM Leadership the monthly COR outcomes


• Tracks and reports to GSM Leadership the Clinical Trial Liaison performance metrics


• Participates in relevant process improvement initiatives.
  
  Problem solving abilities, troubleshooting and critical thinking


• Ability to work independently as well as part of a cross functional team


• Analytical problem-solving experience


• Working knowledge of clinical drug development process as well as ICH GCP


• Effective communication and interpersonal skills; ability to build relationships internally and externally


• Familiarity with medical terms


• Demonstrates writing skills to deliver messages effectively so messages are clearly understood


• Proficiency in required IT applications (includes EDC, CTMS, data repositories and MS Office applications)


• Ability to travel up to 20%