Country Study Start Up Specialist (Hybrid)

Role Summary

The Country SSU Specialist proactively drives and executes all start up and maintenance related activities and deliverables for assigned studies and sites in their assigned country or countries. This role is hybrid (onsite Tuesday - Thursday, remote Mondays and Fridays).

Responsibilities

• Ensure successful and on time and quality execution of start-up and maintenance activities for assigned sites and studies. Competency in establishing the country/site activation plans and priorities including risk assessment and mitigation plans with CCOM/COM, Area SSU and CSM Lead, Contract Manager, CTS/Regulatory Affairs. Proactively identify and communicate issues impacting delivery and providing proposed solutions.
• Attend regional/area start up calls and provide input for assigned sites/studies. Collection of essential documents from sites and completing quality check (ALCOA).
• Compile and submit ethics and other required local document packages including customization of ICFs, patient facing materials and safety reporting.
• Coordinate with Regulatory and CTS on CA submission and approval status to assure alignment with other site activation requirements.
• Collaborate with contract manager, Site Monitor, Area CSM Lead as required to assure timely site activation. Reviewing site and/or IRB/EC comments on ICFs and routing for approval by required functional areas.
• Trigger clinical supply shipments. Complete IP release activities and triggering IP shipment. Issue site green light letter and activating sites in IXRS. Track all start up and maintenance related activities in Vault SSU as appropriate.
• Maintain local country and site intelligence database and EDLs in Vault.
• Maintain SSU performance metrics and KPIs for assigned sites/studies. Provide start up updates and metrics to CCOM/COM and Area SSU and CSM Leads. Ensure audit/inspection readiness.
• Ensure compliance with corporate and divisional policies and procedures in alignment with worldwide regulations and guidelines.
• Participate in process improvement initiatives as required.
• Train and mentor new Specialists, Country Start Up.

Qualifications

• Minimum Qualifications:
  • Bachelor's Degree (degree in health care or scientific field) highly preferred or equivalent years of experience required
  • A minimum of 1-2 years of clinical research experience (CRO or Sponsor)
• Preferred Qualifications:
  • 1+ years of study start up management experience for the designated region.
  • Experience using Veeva Clinical Platform
  • Experience with informed consent reviews
• Other Required Skills:
  • Experience working with remote/virtual teams
  • Strong interpersonal skills with the ability to build trust and communicate with clarity, flexibility and adaptability to changing requirements.
  • Demonstration of successful execution, preferably in start up, and aptitude for managing multiple priorities in a fast-paced environment.
  • Working knowledge of ICH and GCP guidelines and operational understanding of the country's regulatory environment.

Skills

• Remote/virtual team collaboration
• Interpersonal communication; adaptability
• Project management and multi-priority handling
• ICH/GCP regulatory knowledge

Education

• Bachelor's Degree (health care or scientific field) preferred or equivalent experience