Global Study Associate Director (CAR-T)

at  Alexion PharmaceuticalsInc

Location: Mississauga, Canada
Job reference: R-209141
Date posted: 09/18/2024
The Global Study Associate Director (GSAD) is a business-critical role whose main accountability is the delivery of clinical studies. You will lead a cross-functional study team and provide them with direction and guidance to enable successful study delivery. You are also accountable to the Global Project Team (GPT) for the delivery of a study according to agreed upon timelines, budget, and quality standards by ensuring an effective partnership and collaboration within study team and/or external partners.
The GSAD leads the study team in accordance with the Rare Disease Study Team Operating Model for Internal Delivery (rSOLID) and/or clinical outsourcing model, current clinical trial regulations (e.g. ICH GCP), Standard Operating Procedures (SOPs), policies and standard methodologies (e.g. job aides, guidelines), and in line with Alexion’s mission, values, and behaviours.
Studies may be across various therapeutic areas and all phases (I-IV, including Late Phase, Non-Interventional, Post Authorization Safety Studies, Registries, Early Access Programs, etc.).

• Lead and coordinate a cross-functional study team of experts in accordance with rSOLID 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.
• Develop and maintain relevant study documents/plans (e.g., global study management plan and its relevant components, etc.) including required input into clinical study protocol, clinical study report, and study level quality and risk management planning (e.g., risk-based quality management, proactive risk and contingency plans, inspection readiness plans, etc.). •
• Lead and facilitate communication across all functions and provide guidance and support to the core and extended study team members as needed.
• As the leader of the Clinical Trial Team (CTT), is the main point of contact for GPT and the Clinical Sub-Team (CST).
• Accountable for study performance against agreed upon plans, milestones, and key performance indicators (critical metrics, quality and operational).
• Maintain study tracking systems and project timelines (e.g., PLANIT, CTMS, TMF dashboard, etc.) 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 SOPs and collaborate with all functions as vital to overcome barriers and achieve milestones; proactively communicate findings and corrective action plans (CAPAs) to relevant team members (e.g., CPT, quality assurance staff, functional line management, etc.).
• Supervise TMF completion in accordance with relevant 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 studies are inspection-ready at all times, according to ICH-GCP, SOPs, and relevant policies/guidelines. Primary Clinical Operations point-of- contact in the event of an audit or inspection.
• Ensure that the risk response strategies and issue partner concern pathways are clear to the entire study team.
• For outsourced studies, be the primary Alexion point of contact for the CRO Project Manager to ensure study 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, in accordance with relevant SOPs and guidelines (e.g., description of services, transfer of obligations, etc.).
• Ensure all external service providers (e.g., central laboratories, IXRS, ePRO, etc.) engaged at the study level are performing to contracted goals and timelines/budget and that adequate oversight is documented.
• Accountable for planning, tracking and forecasting the Global Clinical Operations budget and timelines for the studies against the agreed goals. Develops and maintains budgets for study(s) that include short and long-range clinical forecasting and monthly accruals based on clinical activity to support Clinical Development financial goals, and identifying any financial risks and mitigation plans (as a part of the ongoing study change control process).
• Work on non-drug project work such as Clinical Operations representative in process improvements and/or leading improvement projects as discussed and agreed upon with their manager.
• Works with global and country teams to resolve appropriate country footprint for the study, including consolidation of information from country teams to support internal governance approvals for the study.
• Leads and coordinates Key External Expert (KEE) outreach activities to assess study design suitability and/or find opportunities for protocol improvement.
• Partners closely with Strategic Feasibility to develop country and site footprint proposals and patient enrolment projections for endorsement by Global Program Team (GPT).
• Maintains global oversight of study results, breakthroughs, and site monitoring throughout the study lifecycle.
• Works with global and country-level team members to mitigate risks or issues related to site management and monitoring as they arise.