Pfizer Associate, Associate Data Manager, Clinical Data Sciences in Collegeville, Pennsylvania
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.
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
- Experience in management of medical and clinical study records and documentation
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
- Pfizer Jobs