Database (programming) Analyst (Associate), Clinical Data Management
USA - NY - Headquarters
Why Patients Need You
As part of the Clinical Data Science (CDS) group, an integral delivery unit within the Global Biometrics and Data Management (GBDM) organization, Database Analysts are responsible for the programming of high-quality clinical databases. Accountabilities to include the design, development, and maintenance of clinical databases, ensuring the integrity of clinical data, application of standards supporting consistency in asset/submission data.
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.
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.
Works closely with department roles and cross-functional study team members to create data capture solutions that support the quality and timely delivery of data required per standard and study specific data review plans.
Complies with applicable SOPs and work practices ·
Learns Pfizer database technologies.
Develops knowledge of data capture tools and methods that support the accuracy and integrity of study data.
Qualifications
Must-Have
Bachelors degree with 1-2 years of experience.
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.
Other Job Details:
Last day to apply: November 18th, 2024
Work Location Assignment: Position is considered Flexible, and colleagues are expected to comply with Log In For Your Day (LIFYD) requirements at site location (e.g. about 2 to 3 days a week in office).
Eligible for Relocation Package - NO
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
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. This position requires permanent work authorization in the United States.
Medical#LI-PFETags: Data management GCP Testing
Perks/benefits: Flex hours Flex vacation Health care Medical leave Parental leave Relocation support Salary bonus
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