Global Study Associate Director

Job Title: Global Study Associate Director

Introduction to role

Are you ready to lead complex, cross-functional clinical studies and turn well-managed plans into outcomes that benefit patients worldwide? In this role, you will guide study teams to deliver with precision—aligning timelines, budgets and quality—to accelerate the journey of life-changing medicines.

As our GSAD, you will be the engine of clarity and momentum, orchestrating sponsor oversight, CRO partnerships, risk-based quality strategies and inspection readiness. You will bring rigor to execution while crafting the conditions for teams to thrive, communicate and solve problems quickly. How will you set the pace, anticipate risk and keep a global study inspection-ready at all times?

Accountabilities

• Lead and coordinate a cross-functional study team of experts according to STOM and its RACI framework. Make sure the clinical study advances as planned. Drive breakthroughs on schedule, within budget, and meeting quality standards.
• Lead and facilitate communication across all functions and provide guidance and support to the core and extended study team members as needed and in accordance with the study-specific communication plan.
• Lead and optimize the performance of study delivery teams ensuring GCP compliance, including provision of timely and accurate performance feedforward for study team members to the appropriate AZ manager or CRO representative.
• Ensure sponsor oversight throughout the conduct of the study.
• For outsourced studies, be the primary AZ point of contact for the CRO Project Manager to ensure study delivery according to agreed timelines, budget, and quality standards, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study, in accordance with relevant AZ SOPs and guidelines (e.g., description of services and transfer of obligations).
• Provide input into and hold accountability for the development of essential study-level documents (i.e., from the Clinical Study Protocol (CSP) through to the Clinical Study Report (CSR)) in accordance with relevant AZ SOPs.
• Be responsible for CRO and other clinically outsourced third-party vendor oversight and ensure all external service providers (i.e., central laboratories, IXRS, ePRO, etc.) engaged at the study level are performing to contracted goals and timelines/budget, and that adequate oversight is documented.
• Develop and maintain relevant study plans (e.g., global study management plan and its relevant components such as the study project plan, SPP), including required input into study-level quality and risk management planning (e.g., risk-based quality management, proactive risk and contingency plans), ensuring that risk response strategies and issue escalation pathways are clear to the entire study team.
• Lead all aspects of study-level performance against agreed plans, achievements, and critical metrics related to quality and operations. Track progress using company systems and project timelines like SPP, data flow metrics dashboard, CTMS, or eTMF dashboard. Inform the CPT of any risks to timelines or quality and suggest mitigations.
• Identify and report quality issues that arise in the study per relevant AZ SOPs. Work alongside partners to overcome challenges and attain results. Proactively inform participants such as CPT, quality assurance staff, and functional line management about findings and corrective action plans (CAPAs).
• Oversee Trial Master File (TMF) completion in accordance with relevant AZ SOPs, including ensuring the TMF plan and Expected Document List (EDL) are in place and that QC activities are performed on an ongoing basis to ensure TMF completeness at all times.
• Ensure timely compliance with company-wide governance controls (e.g., Delegation of Authority, Sunshine Act, ACCORD attestations, Clinical Trial Transparency).
• The GSAD is responsible for study budget re-forecasting following the initial budget estimate provided by the CPT and is accountable for study budget management throughout the study lifecycle, providing budget progress reports to the CPT including any financial risks and mitigation plans (as part of the ongoing study change control process).
• Ensure studies are inspection-ready at all times, according to ICH-GCP and AZ SOPs and relevant policies/guidelines; the GSAD is the primary Study Management & Operations (SMO) point of contact in the event of an audit or inspection.
• Provide regular feedforward on individual performance to the study team members and their line managers to support their professional development; may mentor less experienced colleagues.
• Work on non-drug project work such as leading process improvement projects or participating in workstreams, as discussed and agreed with their manager.

Essential Skills/Experience

• University-level bachelor’s degree (or equivalent), preferably in medical or biological sciences or a discipline associated with clinical research.
• Minimum of 5 years of progressive experience in clinical research, with at least 3 years of clinical development project management experience (or equivalent).
• Extensive knowledge of clinical research regulatory requirements (including ICH-GCP) and demonstrated abilities in clinical study management processes and clinical/drug development.
• Extensive and proven experience in driving operational delivery to timelines, costs, and quality.
• Proven experience leading delivery through internal and external organizations.
• Strong, demonstrated skills in matrix team leadership.
• Strong abilities in establishing and maintaining effective working relationships with internal and external co-workers and stakeholders, along with strong conflict management skills.
• Experience in providing clear requirements and supporting the selection of external contracts.
• Excellent communication and interpersonal skills.
• Strong strategic and critical thinking abilities.
• Strong organizational and problem-solving skills.
• Ability to manage competing priorities.

Desirable Skills/Experience

• Higher university degree (e.g., PhD, MSc).
• Program management certification.
• Proven project management experience at a global level.
• Experience across all phases of the clinical study lifecycle.
• Experience across a variety of academic/CRO/Sponsor organizations and countries.

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Annual base salary for this position ranges from $121,562.40 to $159,550,65.

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. The range provided in this posting represents an offer pay range used in a majority of situations. The base pay offered will vary depending on multiple individualized factors, including the candidate's skills and experience, job-related knowledge, and other specific business and organizational needs.  In some cases, offers outside the range may also be considered to address unique circumstances.

In addition, our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role).  Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program, 4 weeks’ paid vacation, and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.

We are using AI as part of the recruitment process.

This advertisement relates to a current vacancy.

Are you interested in working at AZ, apply today!

AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com.

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Annual base salary for this position ranges from 121,562.40 to 159,550.65.

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. The range provided in this posting represents an offer pay range used in a majority of situations. The base pay offered will vary depending on multiple individualized factors, including the candidate's skills and experience, job-related knowledge, and other specific business and organizational needs.  In some cases, offers outside the range may also be considered to address unique circumstances.

In addition, our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role).  Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program, 4 weeks’ paid vacation, and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.

We are using AI as part of the recruitment process.

This advertisement relates to a current vacancy.