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Manager, Study Configuration & Data Management (Vaccine R&D)

Pearl River, New York
Closing date
Oct 6, 2022
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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

The position sits within the Vaccine R&D Research Informatics organization where the qualified individual will utilize knowledge of informatics, laboratory testing, clinical research operations, and GxP regulatory processes to contribute to configuration of studies and data management. Within this role the individual will be assigned work by the Data Management lead and will partner with scientists, analysts, clinicians, engineers, architects, and various stakeholder groups to ensure information systems are maintained and available for customer use. Specifically, the position is responsible for interpreting Biospecimen Assay and Analysis Plans (BAAPs) for Vaccine R&D studies and translating the contents into study configurations within LIMS. The individual is also responsible for the downstream maintenance, reconciliation, and transfer of the results gathered for these studies. A background in basic computer programming, creating complex spreadsheets to track data, and/or a strong expertise in computer/information systems is expected to manage data and study configuration.

The work is fast paced and both the number of studies, especially with the success of the COVID program, and amount of data continues to grow. Coordination and collaboration are at the center of the fast-paced role, and the individual will have to use best judgement to juggle emergencies, "nice-to-have" requests, and broader needs across many stakeholders, partners, and technical analysts. Meeting deadlines and milestones is critical to the success of Pfizer's vaccine portfolio with extreme care and dedication often required at major study milestones. Work will be expected to be performed mostly independently, with guidance around high-level expectations, and success will be driven by the individual's organizational skills and collaboration across project teams.

Work is performed under strict compliance and SOP guidelines, with attention to detail being critical. Proactive communication with both customers and fellow Research Informatics colleagues AND a passion for innovating is needed to succeed in the role. Work will occur on-site although end-user support of external partners may be required, with travel needed on rare occasions. The individual must be able to juggle priorities, lead broad team meetings, and make adjustments as deadlines evolve.

How You Will Achieve It

  • Under guidance of supervisor, collaborate with other informatics analysts and architects to create or maintain studies/data.
  • Mentor other study management team members as priorities are adjusted.
  • Collaborate with the study clinician / clinical scientist and VRD laboratory manager to create and interpret the BAAP for assigned studies within VRD.
  • Collaborate with Alliance Partners / CROs data management to design and develop the eCRF for the samples that are to be sent to VRD for clinical testing.
  • Collaborate with the VRD laboratory managers to create aliquot distribution plans and workbox types, etc.
  • Collaborate with Sample Management to ensure studies are defined as per sample collection and receipt requirements and ensure discrepancies are resolved for any mismatched events or samples.
  • Ensure active communication exists between various stakeholders to shepherd studies to completion and interim milestones.
  • With the utmost attention to integrity and quality, reconcile (data checks) and transfer final data results to Clinical/GPD or any relevant destinations by agreed upon deadlines.
  • Highlight to supervisor and other informatics leaders any performance gaps and investigate new areas for improvements in managing cross team workload.
  • Maintain detailed notes for assigned tasks, write departmental SOPs, and maintain any technical paperwork or forms as required.
  • Design and execute new or existing reports; Write and execute ad-hoc queries.
  • Complete any assignments associated with external labs and ensure external partner labs can securely analyze and/or transfer data associated with any assigned projects.
  • Contribute to the validation of computer systems as assigned.
  • Mentor junior informatics personnel and partner with consultants when assigned.
  • Maintain highest minimum compliance required by regulatory standards.



  • Bachelor's Degree in Computer Science, Information Systems, OR Life Sciences related degree with 5+ years of relevant experience, a Master's Degree with 3+ years of experience, or a PhD with 0+ years experience.
  • Previous experience supporting clinical trials.
  • Prior knowledge of LIMS.
  • Strong oral and written communication skills.
  • Able to juggle various studies or activities with varying priorities and complexity simultaneously.


  • Contract Research Organization {CRO} and vendor oversight experience
  • Experience working with or as Laboratory Analyst, Data Analyst, Sample Manager, Systems Analyst, Clinical Project Manager, and/or Clinician.
  • Experience with designing, developing, creating reports, and/or querying databases preferred.
  • Experience working with outside laboratories and in establishing data exchanges preferred.
  • Operational experience within regulated laboratories required.
  • Experience within GxP process and with regulated documentation (including system documentation).
  • Expertise within the pharmaceutical or R&D environment.
  • Proficient in using commercial clinical data management systems and/or EDC products

Relocation support available

Work Location Assignment:Flexible

Other Job Details:

Eligible for relocation package

Eligible for employee referral bonus


Relocation assistance may be available based on business needs and/or eligibility.

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.

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