In support of the Clinical Development IPT values, the (Senior) Clinical Study Manager is accountable for the execution and delivery of the study to timelines, budget and quality as defined in the Non-Clinical and Clinical Development Plan and study protocol, and in adherence with GCP-ICH guidelines, GSK CH Written Standards and within regulatory requirements.
The role will involve leading and managing a clinical study team using robust project management tools and operational practices. Interacts with internal teams, as well as external groups and individuals, such as Investigational Sites, Contract Research Organizations and others as needed to help achieve company objectives and to build GSK reputation.
• Conduct and oversight of clinical / human subject research studies, including oversight of CROs and clinical sites according to the Functional Service Provider (FSP) or Full Service Outsouring (FSO) models.
• Strong operational leadership of clinical study teams.
• Acts as HBS custodian
• Subject matter expertise on implementing good clinical practice and evolving trends in clinical operations:
• Leads GSK CH clinical development improvement initiatives and change implementation.
• Developing and deploying the GSK enterprise and CH written standards for the conduct of human subject research and oversight of human biological sample management within clinical development.
Demonstrates the GSK expectations of Courage, Accountability, Development and Teamwork
• Deliver in alignment with GSK values and expections
• Accountable for the implementation, conduct and tracking of clinical trials, according to study timelines, within budget and to project specifications.
• Develops study plan and forecast, including detailed schedule and budget
• Develop and maintains the study Risk Management Plan
• Tracks delivery to time, cost and quality, including maintenance of standard tools such as, eTrack, Finance Tool and MSProject
• Prepares study management, monitoring and communication plans
• Ensures appropriate study oversight including study kick off meeting(s), regular interactions/meetings with Third Parties, review of protocol deviations, escalation process and ensures appropriate follow-up actions are taken
• Set up of Study Workbook, drives regular review of oversight plan, and other study related reports / tools
• Responsible for study-level oversight, communications and issue management
• Ensures appropriate documentation of oversight is available in the TMF at all times.
• Ensures studies are conducted in compliance with ICH/GCP and local regulations, GSK enterprise and CH SOPs and other written standards.
• Leads or participates in vendor and clinical site assessments and due diligence activities.
• Provides operational and strategic advice regarding study conduct and logistics.
• Leads and contributes to process efficiency initiatives within Clin Operations and wider CDMA organisation.
• Forecasts clinical study costs and other study related services, as requested. Reviews detailed budgets from CROs and clinical sites.
• Drives After Action Reviews (AARs) and facilitates other learning activities.
• Typically responsible for 1-3 trials of average design and protocol complexity (Senior Clinical Study Manager)
• Typically responsible for 1-2 trials of basic design and protocol complexity (Clinical Study Manager)
Breadth/ Scope of Accountability*
- 1. Minimum Level of Education* Bachelor’s degree in Science or Health-related field preferred.
- required 3-5 years (Senior Clinical Study Manager) or <3 years (Clinical Study Manager) of significant experience in managing clinical research studies, clinical operations or equivalent. Has a very good understanding of the clinical research and clinical trial management, associated regulatory, processes and quality requirements.
- Track record of success in continuous improvement, innovative work practices and driving changes to achieve these.
- Demonstrated team leader experience either directly and/or as a matrix organization.
- Demonstrated experience representing an organization with external stakeholders, including for example, Contract Research Organizations, Investigational Sites, Healthcare Organizations and External Experts.
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