Principal Clinical Data Manager - Mississauga, Canada - Alexion Pharmaceuticals,Inc.

Alexion Pharmaceuticals,Inc.

Verified Company

Mississauga, Canada

3 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

Location:
Mississauga, Canada; Barcelona, Spain; Dublin, Ireland

Job reference:
R-185327

Date posted: 11/21/2023

Locations:

Mississauga, Canada

Dublin, Ireland

Barcelona, Spain

Hybrid Work Model:

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 (near QEW and Cawthra in Mississauga).

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.

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.

PCDMs will independently lead 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 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 data validation tasks for various studies during maintenance and closeout, 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, adhoc 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:

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 stepin capability to start, maintain, and closeout 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 intelligencebased process enhancements, etc.
Highability to solve complex, abstract problems in crossfunctional business collaboration and independent projects while demonstrating proactive drive, sound decisionmaking, 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 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:

Experience in clinical data management for 6+years.
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

**#LI-Hybrid