This is what you will do:
- As an Associate Director, Portfolio Data Lead, within our Clinical Data Management (CDM) division, you will provide expertise to the leadership of all CDM deliverables across one or more therapeutic area program(s) through all phases, resulting in the successful timely delivery of quality data and strong partnerships with key stakeholders. You'll be tasked with the oversight of leading and successfully delivering complex studies or projects, while also engaging with external partners. Your role involves supervising Lead Data Managers completing various tasks to guarantee the accuracy, completeness, and compliance of data crucial for publications and regulatory submissions of studies within a program. Additionally, your involvement in shaping technical landscapes, business strategies, and healthcare environments through contributions to various initiatives is integral. Your proactive approach to sharing insights and experiences with colleagues, both within and outside the department, is crucial. Collaboration with peers across the data management function and throughout the organization to ensure consistent data management solutions are implemented across a program. Timely completion of data management tasks and providing technical expertise while overseeing project deliverables from Contract Research Organizations (CROs), Functional Service Providers (FSPs), and vendors are also part of your responsibilities. Your role demands critical thinking, collaboration and communication skills, and an entrepreneurial mentality to innovate data collection methods and ensure the development and delivery of medicines for our patients.
You will be responsible for:
- Ultimately accountable for the timely CDM (rCDI) delivery of fit for purpose quality data, serving as the primary CDM point of contact at a program level for key partners.
- Plans, project manages and oversees CDM related activities for a program, including resource requirements, risk identification, risk mitigation, prioritization and timely issue resolution for one or more sophisticated program(s).
- Partners with Directors, rCDI to facilitate mentoring and coaching for CDM staff.
- Collaborates and influences optimally in a consultative manner with internal and external partners, modeling and encouraging partnership and collaboration, including appropriate risk escalation.
- Ensures alignment of the CDM program to the development teams' goals and vice versa to positively impact the study quality and outcome.
- Provides input into the program strategy as a member of or collaborating with senior level delivery teams as appropriate (e.g. Global Project Team (GPT)).
- Builds communication strategies to ensure team members/partners are well informed and kept up to date will all issues on strategy, plans, performance etc.
- Gives technical, therapeutic and business expertise within and external to CDM, including but not limited to current and new technologies and data flow, CDM industry landscape, data standards, therapeutic area expertise, outsourcing expertise, standard methodologies and process improvements.
You will need to have:
- Bachelor’s degree in a scientific field or equivalent.
- Experience in CDM of 8-10+ years or with recent and shown experience managing projects, including deliverables, supervising inspections, budgets and resources.
- Experienced knowledge of the CDM and clinical development process, including the regulatory submission process for the regulatory agencies (FDA, EU, etc.) and knowledge of CDASH, MedDRA/WHO-DD dictionary coding and versioning, 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 complex projects simultaneously while independently handling responsibilities with effective time management and impactful outcomes.
- Strong ability to solve complex, abstract problems in cross-functional business collaboration and independent projects while demonstrating pro-active drive, sound decision-making, and attention to detail.
- High proficiency with technology associated with current and evolving data management practices, including electronic data capture and data aggregating, with exposure to data visualization and 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 team members; maintain general availability during standard business hours.
We would prefer for you to have:
- A master's degree or equivalent experience in a related science field.
- Certification as a Certified Clinical Data Manager (CCDM) from the Society of Clinical Data Management.
- Experience with 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.
- Extensive technical/shown experience.
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.
