Job Description
Job Overview:
ROLE SUMMARY
As part of the Data Monitoring and Management group, an integral delivery unit within the Global Biometrics and Data Management (GBDM) organization, the Associate Data Manager is responsible for timely and high quality data review and query management of clinical data supporting the Pfizer portfolio. The Associate Data Manager executes on key data management deliverables used to collect, review, monitor, and ensure the integrity of clinical data.
ROLE RESPONSIBILITIES
- Participate in DMM activities including data review and query management, ensures quality database design including documentation, testing, validation, and implementation of clinical data collection tools, CRF and non-CRF, using an electronic data capture (EDC) system and/or other data collection systems.
- Ensure work carried out in accordance with applicable SOPs and working practices.
- Ensure the required study-specific DMM documents in the Trial Master File (TMF) are of high quality and are filed contemporaneously to support downstream inspection and submission readiness activities.
- Ensure operational excellence in collaboration with Data Manager and CDS for application of standards, data acquisition, proactive data review and query management, data cleaning, e-data processing, data access and visualization, DM metrics reporting, database release, and submission related activities.
QUALIFICATIONS
- Bachelor’s degree minimum requirement.
- Minimum 1 year of experience in data management.
- Awareness of clinical development process including knowledge and understanding of the principles of GCP.
- Awareness of data management processes and principles in area of responsibility.
- Demonstrates strong verbal and written communication skills including ability to communicate remotely.
- Data Management experience preferred.
- Awareness of FDA & ICH, GCP, GCDMP, and related regulatory requirements
- Experience using commercial clinical data management systems and/or EDC products (e.g. , Inform preferred)
- Experience using data visualization tools (e.g. Spotfire, J-Review) preferred
- Familiarity with MedDRA/WHO-Drug preferred
- Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)
- Ability to travel ~5%
We prefer this role to be site based but we will consider remote based work based on expereince.
#LI-PFE
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.
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.
