Global Study Associate Director, Respiratory and
3 weeks ago
**Global Study Associate Director, Respiratory and Immunology**
**Hybrid Work
- 3 days/week from our Mississauga office**
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 is 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.
**Summary**
The Global Study Associate Director (GSAD) is responsible for leading a cross-functional study team (core and extended) and providing them with guidance to enable successful study delivery. You are the main liaison between the study team and the Clinical Program Team (CPT) starting with study handover through to close-out and archiving. The GSAD is accountable to the CPT for the delivery of a study according to agreed upon timelines, budget and quality standards by ensuring an effective partnership and teamwork within study team and/or external partners.
**What you’ll do**:
- Lead, provide guidance, and delegate appropriately to a cross-functional study team or supervise outsourced delivery activities to ensure the clinical study progresses as planned, driving achievement of milestones according to timelines, budget and quality standards. May hold accountability and/or oversight of several studies.
- Lead and facilitate communication across all functions, including external partners and service providers. Lead and conduct investigator meetings and other study related meetings.
- Provide input and hold accountability for the development of study level documents (i.e., Clinical Study Protocol (CSP) through to Clinical Study Report (CSR))
- Ensure all external service providers (i.e., Contract Research Organizations (CROs), central laboratories, IXRS, ePRO, etc.) engaged at the study level are performing to contracted goals and timelines/budget and that oversight is documented and any issues are escalated appropriately. May participate in vendor selection activities.
- Develop and maintain relevant study plans 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 escalation pathways are clear to the entire study team
- Accountable for ensuring that information in all systems applied at a study-level (e.g. ACCORD/ABACUS, PharmaCM, etc.) are current and accurate.
- Measure study level performance against agreed upon plans, milestones and key performance indicators (KPIs, quality and operational) by using company tracking systems and project timelines. Communicate any risks to timelines and/or quality to CPT and sDSM/DSM along with proposed mitigations
- Identify and report quality issues that have occurred within the study and collaborate with all functions as necessary
- Proactively communicate findings and corrective action plans (CAPAs) to relevant stakeholders (e.g. CPT, quality assurance staff, functional line management, etc.)
- Supervise 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
- Ensure timely compliance with company-wide governance controls (e.g., Delegation of Authority, Sunshine Act, financial system attestations, Clinical Trial Transparency)
- Responsible for study budget re-forecasting and accountable for budget management through the study lifecycle. Providing budget progress reports 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 SOP and relevant policies/guidelines; GSAD is the primary Study Management point-of-contact in the event of an audit or inspection
- Provide regular feedback on individual performance to team members and their line managers to support their professional development; may mentor less experienced colleagues
- Work on non-drug project work such as being a Study Management representative in process improvements and/or leading improvement projects as discussed
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