Global Study Associate Director, Early Phase (Mississauga)

Location: Mississauga, Canada. Job reference: R-255160. Date posted: 06/24/2026. Overview

The Global Study Associate Director (GSAD) is a business‑critical role whose main accountability is the delivery of clinical studies. The GSAD leads a multidisciplinary study group, provides direction and mentorship, and ensures successful study delivery on time, within budget, and meeting quality standards set by the EPT/GPT. The GSAD also ensures effective partnership and collaboration among the research group and with external partners. The GSAD directly leads the study team following the Early Phase clinical outsourcing model (EPA), current clinical trial regulations (e.g., ICH GCP), SOPs, policies and standard methodologies, and in line with Alexion’s mission, values, and behaviours. Studies are focused on Early Phase Healthy Volunteers and may be placed across various therapeutic areas. Responsibilities

Lead and coordinate a cross‑functional study team of experts applying the EPA outsourcing approach and its RACI framework. Ensure the clinical study progresses as planned and drives achievement of breakthroughs according to timelines, budget, and quality standards. Develop or coordinate development/maintenance of relevant study documents and plans, including the global study management plan and its components, input into the clinical study protocol, clinical study report, and study‑level quality and risk management planning. Lead and facilitate communication across all functions and provide mentorship and support to the core and extended study team members. Serve as the main contact for the external vendor (CRO) and collaborate with Global/Early PT and the clinical sub‑team. Accountable for study performance against agreed plans, achievements, and key performance indicators (benchmarks, quality and operational). Maintain study tracking systems and project timelines and communicate any risks to timelines and/or quality to CPT, along with proposed mitigations. Identify and report quality issues that arise during the study, work with all functions as needed to overcome barriers, and share findings and corrective action plans with relevant partners. Coordinate TMF completion according to relevant SOPs and perform QC activities regularly to keep the TMF complete. Ensure timely compliance with company‑wide governance controls such as Delegation of Authority, Sunshine Act, and Clinical Trial Transparency. Ensure studies are inspection‑ready at all times, according to ICH‑GCP, SOPs, and relevant policies/guidelines; act as the primary Clinical Operations point of contact during audits or inspections. Maintain clear risk response strategies and issue partner concern pathways for the entire study team. Provide primary Alexion point of contact for the CRO Project Manager for outsourced studies, ensuring oversight and documentation throughout the lifecycle. Oversee performance of external service providers contracted under the EPA outsourcing model (central laboratories, IXRS, ePRO, etc.), ensuring they meet contracted goals, timelines, and budgets at the study level. Plan, track, and forecast the Global Clinical Operations budget and timelines for studies and coordinate development of study budgets, including forecasting and monthly accruals to support Clinical Development financial goals. Delegate and oversee team member responsibilities and conduct lessons‑learned exercises to provide continuous process improvement. Work on non‑drug project work such as Clinical Operations representative in process improvements and improvement projects, as agreed with the manager. Define the accurate country footprint for the study, gather information from country teams, and help acquire internal governance approvals. Maintain global oversight of study results, milestones, and site monitoring throughout the study lifecycle. Mitigate risks or issues related to site management and monitoring as they arise, in collaboration with global and country‑level partners. Support other study and functional activities as assigned. Qualifications

5–7 years of experience conducting clinical studies, including 2 years in a leading role accountable for planning and execution of global clinical trials. Bachelor’s degree or equivalent experience in clinical practice/health care, life sciences, or drug development. Extensive knowledge of clinical research regulatory requirements and proven abilities in clinical study management processes. Strong team‑leadership skills and proven ability to establish and maintain effective working relationships with internal and external collaborators. Strong conflict management, communication, interpersonal, strategic, critical‑thinking, organizational, and problem‑solving skills. Ability to manage competing demands in an office environment and to use a computer, phone, video, and electronic messaging. Preferred Qualifications

Advanced degree (Master’s or Ph.D.). PMP certification. Experience applying AI and machine learning tools, including generative AI, to streamline clinical study operations, automate workflows, analyse complex data sets, and support strategic decision‑making. Compensation & Benefits

Annual base salary ranges from 127,868.00 to 167,826.75. The base pay offered will vary depending on factors such as skills and experience and business needs. The position offers an annual variable pay bonus/short‑term incentive opportunity and eligibility for an equity‑based long‑term incentive program (if applicable). Benefits include a competitive flex‑benefits & retirement savings program, 4 weeks’ paid vacation, and annual personal days. Fixed‑term contract/temporary positions receive a contract benefits program. AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. In some cases, offers outside the range may also be considered to address unique circumstances.

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