Associate, Associate Data Manager, Clinical Data Sciences

hace 1 día

Buenos Aires, Buenos Aires C.F., Argentina Pfizer A tiempo completo

Work Location Assignment: Buenos Aires, Argentina. Must be able to work from assigned Pfizer office 2-3 days per week, or as needed by the business

ROLE SUMMARY

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.

ROLE 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

QUALIFICATIONS

  • 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)

  • Awareness of MedDRA/WHO-Drug preferred

  • Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)

  • Bachelor's degree minimum requirement. Health Sciences experience or Technology degree preferred.

PHYSICAL/MENTAL REQUIREMENTS

Primarily an office-based position involving sitting in front of a computer for large periods of work time, making presentations, etc. 

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Ability to travel ~5%.

ORGANIZATIONAL RELATIONSHIPS

  • Reporting relationship to Senior Manager, Asset Lead, Clinical Data Sciences, Clinical Data Sciences

  • Supports Study and Asset Teams across Research and Development

EEO (Equal Employment Opportunity) & Employment Eligibility 

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability.

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