Pfizer is a global leader in the pharmaceutical industry, dedicated to delivering innovative health solutions that improve patient outcomes and healthcare effectiveness. Our Worldwide Medical and Safety teams play a crucial role in connecting evidence-based medical decision support with healthcare professionals and stakeholders. At Pfizer, we are committed to empowering healthcare decisions that ensure the safe and appropriate use of medicines for patients worldwide.
Responsibilities in Job
As an Associate Data Manager in Clinical Data Sciences, you will have a significant role in enhancing the oversight of clinical data through stronger ownership, control, and visibility. Your key responsibilities include:
- Data Processing and Review: Manage the processing, reviewing, and receipt of clinical data and records from various therapeutic groups and investigators.
- Timely Data Delivery: Ensure accurate, timely, and consistent data reaches clinical teams and relevant stakeholders.
- Data Management Plans: Actively contribute to data management plans, including data preparation and validation activities.
- Participation in DMM Activities: Engage in Data Monitoring and Management (DMM) activities such as data review and query management.
- Database Design Oversight: Ensure the quality of database design and documentation, testing, validation, and implementation of clinical data collection tools.
- Serve as First Point of Contact: Act as the primary contact for customers with inquiries about Clinical Trial Management System (CTMS) issues.
- Investigate Discrepancies: Identify and investigate discrepancies in data, collaborating closely with the study team to resolve issues.
- Process Improvement Contributions: Participate in process improvement initiatives and additional projects that may arise throughout your tenure.
Qualifications
To be successful in this role, candidates must meet the following qualifications:
- Educational Background: A Bachelor’s Degree in a relevant field.
- Experience with ICH/GCP Standards: Demonstrated experience or knowledge of International Council for Harmonization/Good Clinical Practice (ICH/GCP) documentation requirements.
- Hands-On Experience: Familiarity with electronic documentation management and web-based data management systems.
- Clinical Development Knowledge: Awareness of the clinical development process and an understanding of Good Clinical Practice principles.
- Regulatory Awareness: Knowledge of regulatory requirements and relevant data standards.
- Detail-Oriented and Committed: A consistent, detail-oriented approach with a dedication to excellence.
- Communication Skills: Strong oral and written communication skills in English.
- Technical Proficiency: Proficiency in the Microsoft Office Suite.
Nice-to-Have Qualifications
- Experience in managing medical and clinical study records and documentation.
Skills
The ideal candidate will possess a blend of essential skills, including:
- Strong problem-solving abilities to investigate and resolve data discrepancies.
- Effective collaboration and teamwork skills to create a supportive team environment.
- An analytical mindset to contribute to data monitoring and quality assurance processes.
- Flexibility and adaptability to manage multiple tasks and meet deadlines effectively.
