Global Study Associate Director

Introduction to role

The Global Study Associate Director (GSAD) is a pivotal role responsible for the delivery of clinical studies. As a GSAD, you will lead a cross-functional study team, providing direction and guidance to ensure successful study delivery. You will be accountable to the EPT/GPT for delivering studies according to agreed timelines, budget, and quality standards by fostering effective partnerships and collaboration within the study team and with external partners. The GSAD operates in accordance with the Early Phase clinical outsourcing model (EPA), current clinical trial regulations, Standard Operating Procedures (SOPs), policies, and standard processes, all while aligning with Alexion’s mission, values, and behaviors. Studies focus on Early Phase Healthy Volunteers and Patients across various therapeutic areas.

Accountabilities

- Lead and coordinate a cross-functional study team of experts in accordance with the EPA outsourcing model to ensure clinical study progress as planned, achieving milestones according to timelines, budget, and quality standards.
- Develop or lead all aspects of the development/maintenance of relevant study documents/plans, including input into clinical study protocols, reports, and quality and risk management planning.
- Facilitate communication across all functions and provide guidance and support to core and extended study team members.
- Serve as the main point of contact for external vendors (CRO), Global/Early PT (GPT/EPT), and the clinical sub-team (CST).
- Maintain study tracking systems and project timelines, communicating any risks to timelines or quality to CPT along with proposed mitigations.
- Identify and report quality issues within the study, collaborating with all functions to overcome barriers and achieve milestones.
- Oversee TMF completion in accordance with relevant SOPs, ensuring ongoing QC activities for TMF completeness.
- Ensure timely compliance with company-wide governance controls and that studies are inspection-ready at all times.
- Act as the primary Alexion point of contact for the CRO Project Manager for outsourced studies, ensuring study delivery according to agreed timelines, budget, and quality standards.
- Ensure all external service providers engaged at the study level perform to contracted goals and timelines/budget with adequate oversight documented.
- Plan, track, and forecast the Global Clinical Operations budget and timelines for studies against agreed goals.
- Conduct lessons learned exercises for continuous process improvement and sharing of best practices.
- Work on non-drug project work such as process improvements or leading improvement projects as discussed with their manager.
- Work with global and country teams to determine appropriate country footprint for the study.
- Maintain global oversight of study deliverables, milestones, and site monitoring throughout the study lifecycle.
- Mitigate risks or issues related to site management and monitoring as they arise.

Essential Skills/Experience

- >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 experience related to clinical practice/health care, life sciences, or drug development, or commensurate work experience.
- Extensive knowledge of clinical research regulatory requirements and demonstrated abilities in clinical study management processes and clinical/drug development.
- Strong abilities in establishing and maintaining effective working relationships with internal and external co-workers and stakeholders, along with strong conflict management skills.
- Ability to manage competing priorities.

Desirable Skills/Experience

- Advanced degree or equivalent experience (Masters, PhD)
- PMP

Alexion Canada

Since beginning our operations in Canada in 2009, Alexion has been working tirelessly to bring innovative medicines to the millions of Canadians living with rare diseases. Our pioneering 30-year legacy, our scientific expertise and our commitment to patient-centric decision-making are the foundations of what we are today – a company with a mission to transform lives.

Our Canadian team

We know that people living with a rare disease and their families deserve our unwavering commitment and investment into finding and accessing therapies that help them live longer, fuller lives. Our presence in Canada has grown to over 200 employees and includes a global research and development hub, made up of highly skilled professionals responsible for conducting our clinical trials in Canada and around the world, as well as our dedicated and passionate local teams that ensures our treatments reach those who need them. Together, we are driving patient impact locally and globally.

How we work
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Alexion embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. Alexion 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.

#Li-Hybrid

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.