17 days old

Data Systems BA Lead

Pfizer
Pearl River, NY 10965
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**ROLE SUMMARY**

The High-throughput Clinical Immunoassays & Diagnostics Team (HCID) operates under Pfizer's Vaccine Research & Development organization to produce high-quality assay data in a regulated cGLP laboratory setting. The important work carried out by HCID personnel supports vaccine projects at all stages of development.



This position leads a team of business analysts to:



+ Harmonize business processes across the testing laboratories and various support areas.

+ Develop written end-user requirements for data systems.

+ Rigorously test data systems prior to validation and deployment in the Production environment.

+ Identify and request innovative enhancements to these systems on behalf of the end-user as needed to support new laboratory processes and technologies.



**ROLE RESPONSIBILITIES**



**Lead a team of business analysts in development of end-user requirements for Laboratory Data Systems**



+ Establishes and maintains a consistent, harmonized process across HCID functional areas for the development of end-user requirements for various internal data systems used in the regulated cGLP laboratory space to support process excellence.

+ Leads the development of written end-user requirements for data system builds requested by HCID functional area managers.

+ Responsible for leading the end-user testing of various data system builds against end-user requirements to ensure that these systems function as intended by the end user.

+ Point of contact for VRD Research Informatics personnel to develop and monitor data system project timelines according to VRD priorities.

+ Responsible for developing end-user requirements for any enhancements that support changing laboratory technologies.

+ Evaluates data system processes either purchased or developed outside of HCID prior to deployment of these processes for use in regulated clinical testing.

+ Hosts regular meetings with HCID functional area leaders to review and monitor various data system projects.

+ Works as HCID liaison among stakeholders, line managers, assay leads, Research Informatics and Pfizer digital to document and communicate business needs pertaining to data systems and information management.

+ Lead / manages a team of business analysts.

+ Provides guidance on data-handling system enhancements.

+ Partners with peer colleagues, first and second line managers, and support groups within the high throughput clinical testing environment.

+ Will also interact regularly with the assay development leaders, research informatics groups and Pfizer Digital colleagues.

+ Works as HCID liaison among stakeholders, line managers, assay leads, Research Informatics and Pfizer digital to document and communicate business needs pertaining to data systems and information management.



**Documentation Support**



+ Write and review end-user requirements documents for various data system builds used in HCID per the current good documentation practices.

+ Review and approve various standard operating procedures (SOPs), as assigned.

+ Maintain compliance with SOP periodic review process.

+ Monitor the SOP review and approval workflows for authored SOPs.

+ Harmonize and consolidate SOPs when appropriate.

+ Author, review and approve technical reports, as assigned.



**Training and Safety**



+ Maintain strict compliance with departmental and site safety regulations.

+ Take ownership of and successfully complete all assigned training.



**BASIC QUALIFICATIONS**



+ MS/MA in a science-related discipline such as computer science / mathematics or biological science with at least 5 years of hands-on industry experience with the development and testing of electronic data systems. Or BS/BA with at least 10 years of industry experience.

+ Must have strong verbal and written communication skills.

+ Must have a passion for developing and effectively describe complex laboratory and data-handling processes verbally and in writing in a way that is logical and can be understood by both data system specialists and laboratory personnel.

+ Must have experience successfully leading cross-functional teams and managing personnel.



**PREFERRED QUALIFICATIONS**



+ Strong working knowledge of laboratory information management systems, relational database design, laboratory process development, and a basic understanding / familiarity with SQL and computer programming.

+ Direct hands-on experience with LabWare or other commercial LIMS is desired.

+ Direct hands-on experience working in a regulated (cGLP) environment.

+ Must be able to describe laboratory processes in the form of flow charts and testable, line-item requirements.

+ Proficient in Microsoft Office 365 applications and MS Visio.

+ Strong attention to detail and commitment to operational excellence.

+ Basic working knowledge of laboratory assays that measure antibodies and other macromolecules in various biological fluids.

+ Ability to collaborate and work in a team environment.

+ Experience in a cGLP environment.

+ Lean Six Sigma Black Belt certification is a plus.



**PHYSICAL/MENTAL REQUIREMENTS**



+ The ability to understand, develop and effectively describe complex laboratory and data-handling processes both verbally and in writing is required.

+ Must be attentive to details and have a passion for data quality.

+ Must have proven track record of leading multiple complex projects simultaneously.

+ The ability to understand, develop and effectively describe complex laboratory and data-handling processes both verbally and in writing is required.

+ Must be attentive to details and have a passion for data quality.

+ Must have proven track record of leading multiple complex projects simultaneously.



**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**

Occasional evening and weekend work and some business travel is required.



**Other Job Details:**



+ Eligible for Employee Referral Bonus: YES

+ Eligible for Relocation Package: YES

+ Flexibility to work late hours/weekends if needed.



**\#LI-PFE**



**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.



Information & Business Tech
Posted: 2020-10-13 Expires: 2020-11-13
Sponsored by:
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Data Systems BA Lead

Pfizer
Pearl River, NY 10965

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