Job Description

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.


The GSD is responsible for providing expert input, guidance, direction, mentoring, and support to GSADs on all study related operational activities within Cell Therapy. The GSD will also provide advice and support to GSADs (Global Study Associate Director) related to study team leadership, senior partner management, conflict management, etc. GSDs will also lead other non-drug programs and improvement projects as required.

Lead and coordinate a cross-functional study team of experts in accordance with SOLID and its roles, accountabilities and responsibilities framework (RACI) to ensure the clinical study progress as planned driving achievement of milestones according to timelines, budget and quality standards. Contribute to vendor/ESP selection activities, including bid defense, and lead operational oversight in order to ensure appropriate control over the vendor identification and selection. Collaborate with other functions to establish strategies and identify harmonies sought at growing efficiency of global study teams (core and extended). Provide 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. Ensure all external service providers (i.e. central laboratories, IXRS, ePRO, etc.) are performing to contracted goals and timelines/budget and that adequate oversight is documented through planning & control activities. Develop and maintain 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 pathways are clear to the entire study team. Be responsible for 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. Identify and report quality issues that have occurred within the study in accordance with relevant AZ SOP and collaborate with all functions as required 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.). 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. Ensure timely compliance with company-wide governance controls (e.g. Delegation of Authority, Sunshine Act, financial attestations, Clinical Trial Transparency). Responsible for study budget re-forecasting following initial budget estimate provided by the CPT and accountable for study budget 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).

Typical

Accountabilities

Ensure studies are inspection-ready at all times, according to ICH-GCP and AZ SOP and relevant policies/guidelines. GSD is the primary CTCO Clinical Operations point-of- contact in the event of an audit or inspection. Provide regular feedback on individual performance to the study team members and their line managers to support their professional development. Provide guidance, training, expert input, mentoring and support to less experienced GSL colleagues on an ongoing basis. Leads non-drug project work such as CTCO representative in process improvements and/or leading improvement projects as discussed and agreed upon with their manager.

Education, Qualifications, Skills and

Experience

University degree (or equivalent), preferably in medical or biological sciences or subject area associated with clinical research Proven project management experience and training At least 7 years of clinical trial experience Proven experience in global study leadership and team leadership Demonstrated clinical trial expertise in Oncology Extensive knowledge of ICH-GCP guidelines and clinical research regulatory requirements and experience in all phases of clinical study delivery; startup, maintenance and close out Thorough understanding of the cross-functional clinical trial process eg. Data flow Experience in external provider oversight and management

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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.