Principal Clinical Data Lead (CDL)

This is what you will do:
• As a Principal Clinical Data Lead in our Clinical Data Management (CDM) division, you are responsible for independently ensuring the accuracy and timely delivery of clinical data for highly complex studies. You will also lead or contribute to the evolution of new concepts, technologies, and standards. Your role extends beyond technical expertise as you'll serve as a positive role model for peers, encouraging both technical and social skills. Your role involves performing various tasks to guarantee the accuracy, completeness, and compliance of data crucial for publications and regulatory submissions. Your involvement in crafting technical landscapes, business strategies, and healthcare environments through contributions to various initiatives is integral.

You will be responsible for:
• Collaborating with peers across the data management function and throughout the organization to identify, design and deliver appropriate data management solutions.
• Completing data management tasks, providing technical expertise, and coordinating project deliverables from Contract Research Organizations (CROs), Functional Service Providers (FSPs), and vendors on a timely basis.
• Innovating data collection methods and ensuring the development and delivery of medicines for our patients using critical thinking, strong collaboration and communication skills, and an ambitious mentality.
• Leading or overseeing study-specific study start-up tasks, including case report form (CRF) design, edit check creation, CRF completion guideline (CCG) creation, and user acceptance testing including leading process improvements and enhancements, as needed. Leading the development and maintenance of the data management plan (DMP).
Principal Clinical Data Lead (CDL)
• Leading data validation tasks for complex studies during maintenance and close-out, focusing on data integrity and quality metrics.
• Leading ongoing operational support for all activities during clinical trial conduct, including database migrations, ad-hoc report creation, maintenance of external data transfer documents, import/export agreements and data specifications, and support for database lock, archiving, and clinical coding activities.
• Ensuring all quality and compliance activities are complete, including medical coding, report generation, drug supply, other database integrations, and external data activities.
• Independently monitoring activities and project status for successful project deliverables according to the timeline while participating in initiatives to streamline data management processes.

You will need to have:
• A bachelor's degree in a scientific field or equivalent.
• Experience in clinical data management for 5 or 6+ years or proven experience.
• Thorough knowledge of the clinical data management and clinical development process, including regulatory submissions for various agencies (FDA, EU, etc.) and knowledge of CDASH, application of FAIR (Findable, Accessible, Interoperable, Reusable) principles, MedDRA/WHO-DD dictionary coding and versioning, with exposure to digital technology, and data visualization technology.
• Highly effective written and verbal communication skills are vital to interact with personnel at all levels within and outside the company.
• Strong organizational skills demonstrating the ability to work on multiple projects simultaneously while independently handling responsibilities with effective time management and impactful outcomes.
• Ability to independently solve complex, abstract problems in cross-functional business collaboration and independent projects while demonstrating proactive drive, sound decision-making, and attention to detail.
• Proficiency with technology associated with current and evolving data management practices, including electronic data capture and data aggregation, and with exposure to data visualization/analytics, automated data bots, machine learning/artificial intelligence-based process enhancements, etc.
• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:
• A master's degree in a related science field or equivalent.
• Certification as a Certified Clinical Data Manager (CCDM) from the Society of Clinical Data Management.
• Experience in leading study teams and maintaining oversight of all start-up, conduct and close-out activities for multiple or complex studies, ensuring fit for purpose quality (including oversight of FSPs, Vendors, CROs and Collaborative Groups).
• Experience in leading the collection of clinical trial and/or Real-World Data.
• Good understanding of molecule and disease area strategies, healthcare environments, as well as strong scientific and technical expertise.

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.