Global Study Manager, Haematology (CAR-T Program)

What you’ll do:

• You are a member of the extended global study team supporting delivery of clinical studies to time, cost and quality from Clinical Study Protocol (CSP) development through to study archiving.

• You will work cross-functionally building partnerships with internal and external partners to deliver and provide oversight to ensure successful study delivery

• You will maintain and facilitate interactions with internal functions including Data Management, Procurement, Regulatory, Patient Safety and Quality Assurance, and external functions including the CROs and other outside service providers to ensure an efficient study delivery.

• You will lead and/or participate in the preparation of delegated study documents (e.g. Informed Consent Form, master Clinical Study Agreement etc.) and external service provider related documents (e.g. specifications)

• You will support the Global Study Associate Director (GSAD) in project management as per agreed delegation

• You ensure the supply of study materials and Investigational product by collaborating closely with Clinical Supply Chain or external service providers

• You help support the GSAD with budget management, such as external service provider invoice reconciliation

• You make sure studies are inspection-ready at all times according to ICH-GCP, AZ SOP and relevant policies/guidelines

• You will ensure that all study documents in scope of Global Study Manager's (GSM) responsibilities are completed and verified for quality in the Trial Master File

• You will assist with the planning and conduct of internal and external meetings (e.g. Investigator/Monitors meeting)

• You will monitor study conduct and progress, identifying and resolving risks and issues which may impact delivery of the study to the necessary quality, timeline or budget objectives with the GSAD

• You will contribute to ad hoc team productivity and efficiency by providing direction and facilitating positive team dynamics

• You will have the opportunity to provide input into non-drug project work including training activities and the development of procedures as needed

• You are responsible for collecting and reporting Adverse Events in accordance with AstraZeneca policies and SOPs

Essential Qualifications/ Experience

• University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research

• Minimum 3 years experience within the pharmaceutical industry supporting clinical operations

• Haematology/Oncology experience

• Shown project management, organizational and analytical skills

• Knowledge of clinical development / drug development process across various phases and therapy areas as well as relevant knowledge of international guidelines ICG-GCP

• Global clinical research experience in managing multiple countries

• CAR-T experience

• Vendor management

• Sponsor experience or having worked in a Functional Service Provider (FSP) model previously for another sponsor

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.

Date Posted

Closing Date

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.