Qualifications
Responsibilities
Benefits
Job Title: Global Study Director (GSD)
Location: Mississauga, Canada
Introduction to Role:
The Global StudyDirector (GSD) is a business-critical role within the Rare Diseases Development Operations whose main accountability is the operational planning and delivery of high priority and complex clinical studies and Access to Medicine programs studies within a drug program or across program, that are deemed most critical to the business.
The GSD is responsible for study delivery according to the agreed upon operating model, timelines, budget and quality standards; current clinical trial regulations (e.g., ICH GCP, GVP), AZ Standard Operating Procedures (AZ SOPs), AZ policies and established operating guidance; and in line with AZ values and behaviors.
The GSDleads a cross-functional study team by setting direction, owns study level operational decisions, and establishes consistent operational standards for assigned studies. The role is accountable for early study planning, operational strategy development, and ensures delivery approaches are robust, feasible, and aligned with program objectives. The GSD provides expert operational input into study designs; guidance, mentoring, and support to GSADs, GSMs, and GSAMs to strengthen planning and execution quality, decision making and execution disciplines.
The GSD collaborateswith other internal stakeholders cross-functionally, and/or external partners, to identify, manage and resolve issues affecting study delivery and to ensure an effective partnership and teamwork within the study team and vendors as appropriate.
TheGSD also provides advice and support related to study team leadership, senior stakeholder management, conflict management, etc.
The GSD will also lead other non-drug process improvement projects as required.
Accountabilities:
Study Delivery: The planning and execution of pivotal, high priority and complex clinical studies and Access to Medicine programs with diverse operating models (e.g., internally-led, outsourced, hybrid models) by leading a study team(s) – core and extended, driving achievement of milestones and goals
Study Documents: Provides operational leadership and accountability for the quality, feasibility, and operational integrity of essential study documents from clinical study protocol through clinical study report, ensuring alignment with study strategy and delivery standard.
Study Operational Strategy: Establishes overall strategy and defines the operational standards and documentation for the assigned Study(ies) (e.g., study management, oversight and communication plans, risk mitigation strategy, feasibility assessment, and oversight of operational vendors (e.g., monitoring, labs, imaging, etc.) in collaborations with relevant functions (e,g, rCDI, COM, GSS, etc).
Study Budget: Develops, maintains, tracks and forecasts the Study budget that includes short and long-range forecasting and monthly accruals based on study activities to support program financial goals, resources (allocation) and timelines for the Study against agreed goals
Study Performance Management – Oversees, tracks, and interprets study performance against plans, milestones, KPIs and benchmarks; owns study-level risk and delivery decisions; and communicates risks and mitigations, trade-offs, and recommended actions to senior management.
Vendor and CRO Oversight - Contributes to vendor identification and selection including bid defense, acts as the primary sponsor point of contact, ensures documented oversight per relevant SOPs and guidelines, and drives vendor performance
Quality and Inspection Readiness: Ensures compliance with the International Conference on Harmonization - Good Clinical Practice (ICH-GCP), - Good Pharmacovigilance Practice (-GVP) and EU Clinical Trial Directive, Access to Medicine regulations, throughout the entire development spectrum. Identifies and reports study quality issues and collaborates cross-functionally to implement CAPAs.
Clinical Data: Develops in-depth knowledge of clinical data and ensures appropriate transfer of that knowledge to cross-functional study teams to achieve operational excellence.
Team Leadership and Health: Guides, trains, supports, and provides oversight to Global Study Leads/Managers (GSADs, GSMs and GSAMs) assigned to related Study. Provides regular feedback on individual performance and their line managers,
Governance and Compliance:Represents Clinical Operations at study-level governance forums, leads study-level governance interactions, ensures decision clarity and follow-through, and maintains compliance with Delegation of Authority, financial attestations and clinical transparency requirements.
Functional Operational Excellence:Leads or contributes to functional excellence efforts and initiatives within Development Operations, and/or cross- functional process improvement projects, as requested.
Essential Skills/Experience:
Bachelor’sdegree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development.
>10years of clinical research experience with demonstrated clinical trial experience, 7 of which in leading roles accountable for study delivery including planning, execution and reporting of global studies of diverse development phases (I – IV)
For relevant role, >5 years experience in early access and/or post-trial access programswith solid understanding of relevant regulations and operational best practices
Solid understanding of integrated development/life cycle managementprocess for pharmaceuticals products.
Extensive knowledge of ICH-GCP guidelines and clinical research regulatory requirements
Ability to lead cross-functional teams and to represent clinical operations in relevant forums.
Proven excellent, project, resource, and stakeholder management, problem-solving, decision-making and communicationskills
Ability to manage multiple competing priorities
Extensive experience in external provider oversight and management
Demonstrated
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