Associate Data Manager
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Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
ROLE SUMMARY
As part of the Clinical Data & Information Sciences (CDIS) 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.
ROLE RESPONSIBILITIES
Participate in CDIS 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 CDIS 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 Clinical Data Scientist 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
Bachelors degree minimum requirement. Health Sciences experience or Technology degree preferred.
Minimum 1-3 years Data Management experiencerequired
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 technical 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.)
Work Location Assignment:Hybrid
Please apply by sending your CV and a motivational letter in English
Purpose
Breakthroughs that change patients lives... At Pfizer we are apatient 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 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 iscommitted to celebratingthisin all itsforms 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.
Disability Inclusion
Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!
Required Experience:
Manager
Key Skills
- SQL
- Data Collection
- GCP
- Master Data Management
- R
- Data Management
- Clinical Trials
- User Acceptance Testing
- Data Warehouse
- SAS
- Oracle
- Data Analysis Skills
About Company
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