Associé(e), Gestion des données cliniques – Sciences des données cliniques/ Associate Data Manager, Clinical Data Sciences

Pfizer • Kirkland, QC

5d • CA$64,500 - CA$107,500 • Hybrid

About The Position

As part of the Clinical Data Sciences (CDS) group, an integral delivery unit within the Clinical Development & Operations (CD&O) organization, the Associate Data Manager is responsible for timely and high quality data review and query management of clinical data supporting the Pfizer portfolio. The Associate Data Manager executes on key data management deliverables used to collect, review, monitor, and ensure the integrity of clinical data.

Requirements

• Strong knowledge / understanding of clinical development and pharmaceuticals as a regulated industry
• Strong knowledge / understanding of healthcare regulatory authorities (e.g. FDA, Health Canada)
• Ability to learn clinical data management processes and principles in area of responsibility.
• Minimum 1-3 years Data Management experience required
• Demonstrates required verbal and written communication skills including ability to communicate remotely
• Capable to learn technical data systems
• Capable to learn how to use data visualization tools (e.g. Spotfire, J-Review)
• Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)
• Bachelor’s degree minimum requirement.
• Bilingualism (French and English): An advanced level of English, both spoken and written, is required to enable the individual to collaborate effectively with colleagues and partners located elsewhere in Canada and internationally daily as part of their responsibilities.

Nice To Haves

• Health Sciences experience or Technology degree preferred.
• Awareness of MedDRA/WHO-Drug preferred

Responsibilities

• Participate in CDS activities including data review and query management, assist with quality database design including documentation, testing, validation, and implementation of clinical data collection tools, CRF and non-CRF, using an electronic data capture (EDC) system and/or other data collection systems.
• Ensure work carried out in accordance with applicable SOPs and working practices.
• Ensure the required study-specific CDS documents in the Trial Master File (TMF) are of high quality and are filed contemporaneously to support downstream inspection and submission readiness activities.
• Ensure operational excellence in collaboration with Data Manager and CDS for application of standards, data acquisition, proactive data review and query management, data cleaning, e-data processing, data access and visualization, DM metrics reporting, database release, and submission related activities.

Benefits

• flexible working model that is grounded on empowering colleagues to design their workdays so that they can maximize their productivity, enhance their work-life balance and support a way of working that fosters innovation and patient-centricity.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level