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Why Patients Need You
Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary expertise or investigating how to close gaps in data, our mission is simple. Empower healthcare decisions regarding the safe and appropriate use of medicines for patients.
What You Will Achieve
It is our mission to strengthen the oversight of our clinical data through stronger ownership, control, and visibility. You will play an important role in processing, reviewing and receiving clinical data and records and from therapeutic groups as well as internal and outside investigators. You will ensure that accurate, timely, 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
Work Location Assignment: On Premise
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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Pfizer Chennai, Tamil Nadu, IND Office
Chennai, India
