Country Study Start Up ( Specialist )

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Job details

Company overview

Our client is a global pharmaceutical company with offices across 81 countries.

Responsibilities

Main responsibilities:

• Ensure successful and on time and quality execution of start-up and maintenance activities for assigned sites and studies; site assignment scope 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 providing 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, 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

Requirements

Minimum requirements:

• 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 and preferably 1+ years of study start up management experience for the designated region.
• 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 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

Salary

7 - 10 million yen

Location

Tokyo