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Asso. II, RQC

Pfizer


Location:
Wuhan Shi, Hubei 430015
Date:
12/22/2017
2017-12-222018-01-22
Pfizer
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Job Details

JOB TITLE: Registry Quality Management Associate



REPORTS TO: Registry Quality Management Associate (RQMA) Lead



DIVISION/BUSINESS LINE: Global Product Development



SUB DIVISION: Clinical Development Quality



DEPARTMENT NAME: China Clinical Quality Management & Services



LOCATION(S): Wuhan, China



JOB SUMMARY



Summarize the primary purpose & key accountabilities of the job.



Registry Quality Management Associate implements Registry Quality Management activities to ensure the completeness and accuracy of registry data in a timely manner.



Perform Quality Control on attributes submitted to the Clinical Trial Management System (CTMS), utilizing the source documents and data from various systems to validate the Registry Data Attributes, and escalate any potential quality issue.



Perform Registry Data Entry work in Clinical Trial Management System (CTMS) via utilizing the source documents and data from various systems.



Liaises with the study team Point of Contact to resolve any verified quality issues.



Assist in the remediation of any incompleted or inaccurate registry data.



Serve as the first Point of Contact for customers needing assistance with Clinical Trial Management System (CTMS) questions and issues.



Act as a Subject Matter Expert for the Registry process, related systems and tools.



JOB RESPONSIBILITIES



Indicate the primary responsibilities critical to the job.



General



Perform Quality Control on Registry Data Attribute



- Upon direction, run and review the Registry Quality Management reports or other logic check mechanisms throughout clinical study life.



- Investigate logic check flags, utilizing system information, as well as applicable study documentation.



- Review data attributes populated by general users for adherence to Registry Data Quality Specifications.



- Identify and investigate any potential discrepancies Review findings with the study team Point of Contact to verify .



Create, modify or delete data attributes in the Clinical Trial Management System (CTMS) according to Registry Data Entry specifications.



Liaise with Study Team Point of Contact to resolve registry related discrepancies and issues.



Function as subject matter expert for Registry systems and tools.



Communicate, escalate issues to the Registry Quality Management Associate Lead and/or pertinent stakeholders



Contribute to process improvement and additional project that may arise.



Generate metrics report when needed.



QUALIFICATIONS / SKILLS



Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications and other job-related technical and managerial skills.



Excellent English verbal and written communications skills and outstanding listening skills are required.



History of achievement in a customer service role with demonstration of meeting customer needs and concerns required.



Proven history of leadership roles within a team environment required.



Experience with Clinical Trial Management Systems preferred.



Experience in management of medical/clinical study records and documentation preferred.



Experience/knowledge of ICH/GCP documentation requirements preferred.



Metrics management experience (preferably within the field of Clinical Research) preferred.



Experience with web based data management systems preferred.



Experience with database utilization preferred.



Minimum of Bachelor's degree or equivalent required.



Technical Competencies:



Computer savvy with widely used systems e.g. MicroSoft Office: Working knowledge of electronic document management systems



Understanding of a Clinical Trial Management System and its components: Knowledge of the principles and practices of traditional and electronic records management as applied to the pharmaceutical or related industry



Organizational skills: Ability to work independently. Ability to organize tasks, time and priorities of self ; ability to multi-task



Administrative excellence: Attention to detail evident in a disciplined approach to document maintenance and management



Clinical/Scientific aptitude: Understanding of scientific/clinical principles, and ability to work across different therapeutic areas



Technology management: Understanding of technologies to support data attribute collection and data entry, awareness of CFR 21 part 11



Decision Making: Ability to understand the sources of various data points, and how to mine that information for meaningful data; Ability to make routine decisions based on following set guidelines and procedures



Problem Solving: Ability to proactively identify issues and work within a team to address



ORGANIZATIONAL RELATIONSHIPS



Provide the primary groups or key role(s) that this role will have interaction with as a regular part of the Job responsibilities. Include any external interactions as appropriate.



Reports directly to Registry Quality Management Associate (RQMA) Lead



Liaise with Study Team Point of Contact







N: Not Applicable - (China)



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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