Principal Clinical Data Manager, Clinical Data

3 weeks ago

Mississauga, Canada Alexion Pharmaceuticals,Inc. Full time

Location: Mississauga, Canada

Job reference: R-199580

Date posted: 05/13/2024

**This is what you will do**:
A Principal Clinical Data Manager (PCDM) (Level CDM IV) has keen attention to detail and is responsible for overseeing the start-up and execution of several trials with a CRO or in-house to ensure data quality and integrity. The position will independently leads multiple, high volume, and highly complex studies within a development program. The individual will perform various complex tasks to ensure complete, accurate, high quality, and regulatory compliant data supporting publications and regulatory submissions. The PCDM role is in the individual contributor track with growth toward project-based management.

**You will be responsible for**:

- Acting as the primary or lead data manager responsible for 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 data validation tasks for various studies during maintenance and close-out, focusing on data integrity and quality metrics.
- Leading the development and maintenance of the data management plan (DMP).
- Leading ongoing operational support for all activities, and at times leading specific projects or tasks, 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 and archiving activities.
- Accountable for all quality and compliance activities, including medical coding, report generation, drug supply, other database integrations, and external data activities.
- Independently monitor 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**:

- Experience in clinical data management for 6+years.
- A Bachelor’s degree in a scientific discipline or equivalent.
- Thorough knowledge of the clinical data management and clinical development process, including the regulatory submission process for the FDA, MHRA, PMDA, Health Canada, and EU regulatory agencies and knowledge of CDASH, MedDRA/WHO-DD dictionary coding and versioning, with exposure to digital technology, and data visualization technology.
- Thorough knowledge and experience in clinical data operations and processes with skills supporting immediate step-in capability to start, maintain, and close-out studies, if needed.
- 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.
- High-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.
- Highly effective written and verbal communication skills are necessary to interact with personnel at all levels within and outside the company.
- 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

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