Job Description

Employment Type: Full time Work Schedule: Standard (Mon-Fri) Environmental Conditions: Office

Position Overview

This role is responsible for assisting local study teams in coordinating the planning, start-up, and maintenance of operational activities for clinical studies. The goal is to ensure these activities are conducted within agreed budgets, timescales, and in accordance with GSK written standards and ICH GCP.

Key Responsibilities

• Study Coordination & Planning:
  • Assist local study teams in coordinating the planning, start-up, and maintenance of operational activities for clinical studies.
  • Ensure activities are within budget, timescales, and adhere to GSK written standards and ICH GCP.
• Knowledge & Expertise:
  • Acquire and maintain an optimal level of knowledge in all areas to effectively perform study activities.
  • Act as a local expert/champion or subject matter expert in a business system/process.
  • Maintain up-to-date participating site information, including contact details, contracts, and reports.
• Documentation & Approvals:
  • Responsible for the preparation, collation, review, and tracking of all documentation required for approval processes (e.g., regulatory, ethics, green light process).
  • Prepare Investigator and Sponsor files with essential documents for site initiation.
  • Assist with maintaining sponsor files during the study lifecycle.
  • Responsible for archiving at the end of the study in accordance with GSK SOPs, policies, and local regulatory requirements.
• Logistics & Support:
  • Manage all logistical aspects of clinical studies according to GSK operating standards and good clinical practice.
  • Ensure studies receive the necessary support to meet timelines and budget.
• Regulatory & Ethics Liaison:
  • Assist with study and site-related processes (e.g., handling data queries).
  • Assist the LDL with the submission of Clinical Study Applications to Regulatory Authorities (RA) and local Ethics Committees (ECs).
  • Maintain communication with RA and ECs to ensure timely compliance with all regulatory requirements throughout the study.
• Milestone Monitoring & Tracking:
  • Oversee local activities required for monitoring study milestones at each stage.
  • Input and oversee clinical study tracking systems, including CTMS, OPAL, submission lists, shipment lists, safety database, and metrics database.
  • Amend inaccurate milestones and ensure all issues are communicated and escalated appropriately.
• System Accuracy & Issue Resolution:
  • Responsible for the accuracy of study systems.
  • Proactively identify issues and raise them for corrective action to ensure smooth study progress.
• Financial Operations (Local Requirements):
  • May be responsible for managing financial operational aspects, including benchmarking, budget assistance, forecasting, purchase order setup, invoice reconciliation, payment tracking, and providing monthly accruals to finance.
  • Handle query resolution related to financial aspects.
• Vendor Management (Local Requirements):
  • May be responsible for overseeing clinical and ancillary supplies vendors.
  • Prepare and review importation documentation and logistics.
• Team Engagement & Administrative Support:
  • Engage in local study meetings to gain general study knowledge and complete assigned tasks.
  • Assist with study-related activities such as organizing meetings, scheduling travel, producing minutes, assembling training materials, updating contact details, and maintaining study documentation.
• System Management & Communication:
  • Accountable for acquiring/maintaining an optimal level of knowledge of GSK tools and systems.
  • Serve as the single point of contact for local study teams for study support questions.
  • Maintain effective communication and working relationships with investigators, site staff, above-country colleagues, and other GSK staff.
• Compliance & Training:
  • Adhere to GSK written standards, processes, and ICH GCP guidelines.
  • Stay up-to-date with changes in ICH GCP and GSK written standards.
  • Attend appropriate training sessions.

Company Information

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