Principal Clinical Data Lead Job Mississauga area,Ontario Canada,IT/Tech

Are you ready to lead clinical data strategy that accelerates therapies for patients with rare diseases? Do you thrive at the intersection of scientific rigor, innovation, and multi-functional coordination where high-quality data drives pivotal decisions?

As the senior lead for clinical data, you will develop the processes for collecting, curating, and unlocking clinical data. This applies to sophisticated, global studies. You will partner across development, biostatistics, clinical operations, and safety to deliver credible, inspection-ready evidence that advances our pipeline and reaches under-served patient populations sooner. Your leadership will elevate vendor performance, modernize data collection, and ensure every database locks with confidence—so patients and caregivers can benefit from our medicines faster.

Accountabilities:

Data Strategy and Build:
Define study data strategies, standards, and solutions that align with protocol objectives, endpoints, and regulatory expectations, ensuring data supports crucial analyses and submissions.

Study Start-up Leadership:
Own the building of data collection instruments, development of data validation rules, completion guidelines, and user acceptance testing; take ownership of the data handling strategy and drive process improvements to reduce cycle time and errors.

Data Quality and Integrity:
Lead validation for sophisticated studies, set quality metrics, and implement risk-based approaches that proactively detect and resolve issues to protect data credibility.

Vendor and Partner Oversight:
Provide technical direction and governance to CROs, FSPs, and data vendors. Ensure your work meets scope, quality, and timelines, raising issues and adjusting plans when needed.

Operational Excellence:
Orchestrate ongoing data operations across external data transfers, specifications, agreements governing the import and export of data, database migrations, ad-hoc reporting, coding activities, lock and archiving—keeping studies on track.

Introduce and evaluate new methods for data capture. Include supplementary information sources outside the organization. Promote innovation that improves data completeness, patient experience, and study efficiency.

Compliance and Preparation for Inspections:
Ensure medical coding, reporting, drug supply interfaces, collaborative platforms, and third-party data functions follow quality standards and are audit-ready.

Establish and monitor delivery plans, important metrics, and status across studies. Anticipate risks, remove blockers, and improve data management workflows for faster, reliable outcomes.

Essential Skills/

Experience:

Collaborating with peers across the data governance function and throughout the organization to identify, develop and deliver appropriate data management solutions.

Providing technical expertise and completing data management tasks. Leading work from CROs, FSPs, and vendors to ensure timely completion.

Innovating data collection methods and ensuring the development and delivery of medicines for our patients using strategic thinking, strong collaboration and communication skills, and an entrepreneurial mindset.

Leading or coordinating study-specific study start-up tasks, including case report form (CRF) build, edit check creation, CRF completion guideline (CCG) creation, and validation by end users 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 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…


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