Job Description

Employment Type: Full-time Work Schedule: Standard (Mon-Fri) Environmental Conditions: Office Location Type: [Not Specified] Salary: [Not Specified]

Position Overview

This role is accountable for all aspects of site management, ensuring the high-quality setup, execution, and completion of studies to agreed timelines. The position involves extensive site interaction, monitoring, and ensuring compliance with regulatory requirements and company standards.

Key Responsibilities

• Site Management:
  • Accountable for all aspects of site management, ensuring timely completion and delivery of local study activities.
  • Conducts operational site evaluation visits, study initiation visits, monitoring visits (Risk Based Monitoring), and site closeout visits.
  • Collaborates with study teams for feasibility and site selection.
  • Determines study feasibility based on protocol complexity, staff availability, clinical facilities, patient recruitment potential, and compliance with ICH GCP and GSK requirements.
  • Works with the Local Delivery Lead (LDL) to conduct local study/site risk assessments.
  • Assists with audits and inspections.
• Communication and Reporting:
  • Communicates progress and relevant study information to the local study management team and key stakeholders (e.g., CRA Manager/Lead).
  • Escalates study issues as appropriate.
  • Ensures critical study timelines related to monitoring activities are achieved.
• Performance and Quality Assurance:
  • Ensures recruitment targets, patient recruitment cycle times, data quality, audit quality, and site-related milestones are met.
  • Maintains good relationships with sites, communicating patient inclusion/exclusion criteria, study stop/go decisions, timeline changes, early terminations, and status changes.
  • Works with sites to ensure timely resolution of data queries.
  • Ensures Investigator and site staff receive safety reports and new safety information promptly.
• Regulatory and Compliance:
  • Assists with the submission of Clinical Study Applications to Regulatory Authorities (RA) and local Ethics Committees (ECs), maintaining communication to ensure timely fulfillment of all regulatory requirements.
  • Ensures clinical study activities are conducted in accordance with the clinical trial agreement and related contracts.
  • Responsible for maintaining sponsor files during the study lifecycle and assisting with archiving in accordance with GSK SOPs, policies, and local regulatory requirements.
• Study Supplies Management:
  • Ensures timely availability of necessary study supplies at sites and maintains appropriate accountability.
  • Ensures all unused study supplies are accounted for and appropriately destroyed.
• Training and Knowledge Development:
  • Delivers appropriate training to site staff and other relevant parties as required.
  • Acquires and maintains an optimal level of knowledge in all areas to effectively perform study activities.
  • May serve as a local expert/champion or subject matter expert in a business system/process.
  • Shares best practices within the Local Operating Company (LOC) and with colleagues in other LOCs.
  • Acquires and maintains knowledge on the pathology of the disease area, study compound, protocol, and all study-related activities.
  • Attends internal project meetings and relevant training courses, continuously improving personal/professional skills.
  • Stays updated on ICH GCP, GSK written standards, and attends appropriate training sessions.
• Travel:
  • Available and willing to travel as required by the job.