#4927207
y, and consistent data reaches the clinical teams and other groups. You will be relied on for data management plans including data preparation and validation activities, among others.
As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative team environment for your colleagues.
It is your commitment and hard work that will help make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
Contribute to completion of project milestones and organize own work to meet project task deadlines.
Participate in Data Monitoring and Management (DMM) activities including data review and query management.
Ensure quality database design including documentation, testing, validation, and implementation of clinical data collection tools, and/or other data collection systems.
Serve as the first Point of Contact for customers needing assistance with Clinical Trial Management System (CTMS) questions and issues.
Ensure work is carried out in accordance with applicable Standard Operating Procedures (SOPs) and working practices.
Investigate logic check flags, utilizing system information, as well as applicable study documentation.
Liaise with Study Team Point of Contact, Document Owners, Trial master file (TMF) Study Owners and/or other end users to resolve document related discrepancies and issues.
Identify and investigate any potential discrepancies and review findings with the study team Point of Contact to verify.
Contribute to process improvement and additional project that may arise.
Qualifications
Must-Have
Bachelor's Degree
Demonstrated experience or knowledge of ICH/GCP (International Council for Harmonization/ Good Clinical Practice) documentation requirements
Hands-on experience with electronic documentation management systems and/or web based data management systems
Awareness of clinical development process including knowledge and understanding of the principles of Good Clinical Practice
Understanding of regulatory requirements and relevant data standards
Consistent, detail-oriented, and dedicated to excellence
Strong oral and written English communications skills
Proficiency in the use of Microsoft Office Suite of tools
Nice-to-Have
Experience in management of medical and clinical study records and documentation
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Medical
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