Associate, Data Management, CDS

ROLE SUMMARY
As part of the Clinical Data Sciences (CDS) g roup, an integral delivery unit within the Global Biometrics and Data Management (GBDM) organization, the Associate, Data Management, CDS is responsible for timely and high quality data review and query management of clinical data supporting the Pfizer portfolio . The Associate, Data Management, CDS executes on key data management deliverables used to collect, review, monitor, and ensure the integrity of clinical data.
ROLE RESPONSIBILITIES

• Participate in CDS activities including data revie w 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

QUALIFICATIONS

• Bachelor's degree minimum requirement. Health Sciences experience or Technology degree preferred.
• Minimum 1-3 years Data Management experience required
• 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.
• Demonstrates required verbal and written communication skills including ability to communicate remotely
• Capable to learn tech ni cal data systems
• Capable to learn how to use data visualization tools ( e.g. Spotfire, J -Review)
• Awareness of MedDRA/WHO-Drug preferred
• Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)

LI#PFE
Purpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Flexibility
We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let's start the conversation!
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms - allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
Medical
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