Introduction to Role:
Join our dynamic team at Alexion, a division of AstraZeneca, as an Associate Director Project Manager Country Operations (AD PMCO). This role is pivotal in ensuring the successful execution of study deliverables and the quality execution of high priority and complex protocol procedures. You will be leading local study teams, ensuring rapid start-up activities across assigned studies, and driving adherence to timelines and milestones of study goals. This is a unique opportunity to make a significant impact on patient lives in a company where 'Here it means more' is more than a statement, it’s an ethos.

Accountabilities:
As an AD PMCO, you will be responsible for the quality and timeliness of study deliverables, including site identification, feasibility, start up, recruitment, data deliverables, filing of complete study documentation and sites closures for assigned study(ies). You will also be accountable for leading risk-based quality meetings, project performance reviews, and managing high priority / complex studies through phases 1 – 4. 

Essential Skills/Experience:

• Proven experience in oversight and leading the delivery of operational aspects of all stages of the clinical trial process.

• Solid knowledge of clinical development processes, with previous project/site management experience.

• Ability to lead, troubleshoot and influence for quality and delivery.

• A track record of ensuring GCP compliance and successful risk management of complex clinical studies.

• Proven experience in effectively communicating with site staff including KOLs and thought leaders.

• Comprehensive and current regulatory knowledge, including GCP.

• Experience conducting GCP or other training is a plus.

• Flexibility in schedule and willingness to travel (required travel may be as high as 20% during busy periods).

• Bachelor's Degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences or drug development.

• A minimum of 5 years of relevant experience gained with a CRO or pharmaceutical company working on internal delivery model, multinational clinical studies; Lead CRA/management experience preferred.

• Strong project management skills.

• Previous oversight and regulatory inspection experience preferred.

• Excellent understanding of the end to end Clinical Study Process including monitoring.

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 E-Mail schreiben.

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.