Associate Data Manager, Clinical Data Sciences
Job Location:
New York City, NY - USA
Monthly Salary:
Posted on:
Vacancies:
Job Summary
ROLE SUMMARY
As part of the Clinical Data Sciences (CDS) group an integral delivery unit within the Clinical Development & Operations (CD&O) 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 CDS activities including data review and query management assist with 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 CDS 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
- Bachelors degree minimum requirement. Health Sciences experience or Technology degree preferred.
- 0 - 2 years Data Management experience required
- Strong knowledge / understanding of clinical development and pharmaceuticals as a regulated industry
- Strong knowledge / understanding of healthcare regulatory authorities (e.g. FDA Health Canada)
- Ability to learn clinical data management processes and principles in area of responsibility.
- Demonstrates required verbal and written communication skills including ability to communicate remotely
- Capable to learn technical data systems
- Capable to learn how to use data visualization tools (e.g. Spotfire J-Review)
- Awareness of MedDRA/WHO-Drug preferred
- Proficiency in the use of Microsoft Office Suite of tools (Outlook Word Excel etc.)
Work Location Assignment:Hybrid
Relocation assistance may be available based on business needs and/or eligibility.
Candidates must be authorized to be employed in the U.S. by any employer.
U.S. work visa sponsorship (such as TN O-1 H-1B etc.) is not available for this role now or in the future.
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 providers 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.
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MedicalRequired Experience:
Manager
About Company
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