Principal Clinical Data Lead CDL
Principal Clinical Data Lead CDL
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Salary Not Disclosed
1 Vacancy
Job Description
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 youll 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 studyspecific study startup 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).
Leading data validation tasks for complex studies during maintenance and closeout focusing on data integrity and quality metrics.
Leading ongoing operational support for all activities during clinical trial conduct including database migrations adhoc 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 bachelors 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/WHODD 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 crossfunctional business collaboration and independent projects while demonstrating proactive drive sound decisionmaking 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 intelligencebased process enhancements etc.
The duties of this role are generally conducted in an office environment. As is typical of an officebased 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 nonlinear thought analysis and dialogue; collaborate with others; maintain general availability during standard business hours.
We would prefer for you to have:
A masters 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 startup conduct and closeout 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 RealWorld 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 30year legacy our scientific expertise and our commitment to patientcentric decisionmaking 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 lifechanging medicines. Inperson working gives us the platform to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were 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 industryleading 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 nondiscrimination 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 .
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Date Posted
14Apr2025Closing Date
27Apr2025Alexion 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 lackthereof sex sexualorientation age ancestry national origin ethnicity citizenship status marital statuspregnancy (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 aninteractive dialogue with Alexion regarding an accommodation please contact . Alexion participates in EVerify.
Required Experience:
Staff IC
Employment Type
Full-Time
