Job Description

The Specialist, Country SSU proactively drives and executes all start-up and maintenance-related activities and deliverables for assigned studies and sites in their assigned country or countries. Note: Specialists will report into their local country COM but have an operational reporting line to Area and Global SSU LeadsResponsibilities:

• Ensure the successful, on-time, and quality execution of start-up and maintenance activities for assigned sites and studies; the site assignment scope is primarily central IRB/EC sites.
• Establish 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 submissions 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, CRA, and Area CSM Lead as required to ensure 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 trigger IP shipment.
• Issue site green light letter and activate 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 and drive process improvement initiatives as required.

Requirements and Qualifications:

• Degree (degree in health care or scientific field).
• A minimum of 3 years of clinical research experience and preferably 1+ years of study start-up management. experience for the designated region.
• Experience in VEEVA VAULT or similar Clinical Trial Management System for project management.
• Exposure in site selection, feasibilities, and budget reviews.
• Experience working with remote/virtual teams.
• Strong analytical and critical thinking skills and the ability to evaluate complex issues from multiple perspectives.
• Strong interpersonal skills with the ability to build trust and communicate with clarity, flexibility and adaptability to changing requirements.
• Demonstration of successful start-up and activation, and aptitude for managing multiple priorities in a fast-paced environment.
• Working knowledge of ICH and GCP guidelines and operational understanding of the country & apos;s regulatory environment.

Candidates that meet the criteria may apply via this portal or via www.mnarecruitment.com
Should you not receive feedback within 7 days, please accept your application as unsuccessful

MNA Recruitment