Associate, Clinical Data Management - Pfizer
About the Opportunity:
Pfizer Worldwide Medical and Safety teams are essential in supporting evidence-based healthcare decisions to ensure safe and effective treatment outcomes for patients. As an Associate in Clinical Data Management, you will play a pivotal role in processing, reviewing, and managing clinical data, ensuring that accurate and consistent information reaches clinical teams and stakeholders. Your expertise will contribute to strengthening oversight and visibility of clinical data, which will drive the success of critical projects and milestones.
What You Will Achieve:
In your role, you will:
Support Data Monitoring and Management: Participate in data monitoring and query management activities to ensure the quality and completeness of clinical data.
Ensure High-Quality Data Collection Tools: Contribute to the design, testing, validation, and implementation of clinical data collection tools and systems.
Serve as Point of Contact: Be the primary contact for customers seeking assistance with the Clinical Trial Management System (CTMS) and resolve any issues or questions.
Collaborate with Teams: Work closely with Study Team Points of Contact, Document Owners, and Trial Master File (TMF) Study Owners to resolve document-related discrepancies and ensure compliance with project requirements.
Process Improvement: Identify areas for improvement and contribute to process enhancements to optimize data management workflows.
Adhere to Standards: Ensure that all tasks are conducted in compliance with Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory standards.
Qualifications:
Must-Have:
Education: Bachelor’s Degree.
Experience: Knowledge of ICH/GCP (International Council for Harmonization/Good Clinical Practice) documentation requirements.
Systems Proficiency: Hands-on experience with electronic documentation management systems and web-based data management systems.
Clinical Development Knowledge: Understanding of the clinical development process, regulatory requirements, and data standards.
Detail-Oriented: Ability to ensure the highest standards of data accuracy and consistency.
Communication Skills: Strong oral and written English communication skills.
Technical Skills: Proficiency in Microsoft Office Suite.
Nice-to-Have:
Experience: Prior experience in managing medical and clinical study records and documentation.
Work Location:
On Premise
Why Pfizer:
Pfizer is committed to being an equal opportunity employer and complies with all relevant equal employment opportunity legislation. Join Pfizer, and help drive progress in patient care and support the development of groundbreaking therapies.
#LI-PFE
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