Associate Director, Clinical Trial Management

2 months ago


Mississauga, Canada AstraZeneca GmbH Full time
p>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 the 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.).

You will be responsible for:

  • 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 progresses as planned, driving achievement of milestones according to timelines, budget, and quality standards.
  • 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., 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.
  • 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.

You will need to have:

  • 7+ years of clinical research experience, 2 of which in a leading role accountable for the planning and execution of global clinical trials.
  • Bachelor’s degree or equivalent.
  • CAR-T Experience.


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