Global Study Director (GSD)

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe.

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

Typical Accountabilities (per AZ framework and regulatory expectations):

• Leads and coordinate a cross-functional study team of experts in accordance with STOM and itsroles, accountabilities and responsibilities framework (RACI) to ensure the clinical study progress as planned driving achievement of turning points according to timelines, budget and quality standards.

• Contributes to vendor/ESP selection activities at the study level, including bid defense, and lead operational oversight at the study level in order to ensure appropriate control over the vendor identification and selection.

• Assists the (Sr)GPD/DSM with the operational planning for upcoming clinical studies to establish required number of resources for study conduct, working with other cross-functional partners and the TA as required.

• Collaborates with other functions to establish strategies and identify alignments sought at growing efficiency of global study teams (core and extended).

• For outsourced studies, be the primary AZ point of contact for the CRO Study Manager to ensurestudy delivery according to agreed upon 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.

• Provides operational expertise into and hold accountability for the development of crucial study level documents (i.e. Clinical Study Protocol (CSP) through to Clinical Study Report (CSR)) in accordance with relevant AZ SOPs.

• Ensures all external service providers (i.e. central laboratories, IXRS, ePRO, etc.) engaged and are performing to contracted goals and timelines/budget and that adequate oversight is documented through planning & control activities.

• Develops and maintains relevant study plans (e.g. global study management plan and its relevant components such as 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, etc.), ensuring that the risk response strategies and issue concern pathways are clear to the entire study team.

• Coordinates study level performance against agreed upon plans, achievements and key performance indicators (critical metrics, quality and operational) by using company tracking systems and project timelines (e.g. SPP, data flow metrics dashboard, CTMS or eTMF dashboard) and communicate any risks to timelines and/or quality to CPT, along with proposed mitigations.

• Identifies and reports quality issues that have occurred within the study in accordance with relevantAZ SOP and collaborate with all functions as necessary to overcome barriers and achieve breakthroughs; proactively communicate findings and corrective action plans (CAPAs) to relevant partners (e.g. CPT, quality assurance staff, functional line management, etc.).

• Is responsible for Trial Master File (TMF) completion, 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.

• Ensures timely compliance with company-wide governance controls (e.g. Delegation of Authority, Sunshine Act, ACCORD attestations, Clinical Trial Transparency).

• Responsible for study budget re-forecasting following initial budget estimate provided by the CPT and accountable for management through the study lifecycle and for providing budget progress reports to the CPT including any financial risks and mitigation plans (as part of the ongoing study change control process).

• Ensures studies are inspection-ready at all times, according to ICH-GCP and AZ SOP and relevant policies/guidelines.

• Supports professional development of team by providing regular feedback on individual performance to the study team members and their line managers 

• Leads non-drug project work such as SMO/Haematology representative in process improvements and/or leading improvement projects as discussed and agreed upon with their manager.
  

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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.