Clinical Biospecimen & Data Specifications Manager, Vaccines

ROLE SUMMARY

In this role in our Quality and Compliant Operations (QCO) group you will support the Vaccine Research & Development (VRD) Clinical Compliance Head and Research Informatics Head as a conduit to ensure clinical study protocols are translated for use downstream where systems must be configured for biospecimen receipt and testing. Acting in the capacity of a Project Manager, you will bring together various stakeholders to better enable the exchange of information and to improve the transparency of managing collective requirements. You will ensure compliance with global regulatory requirements, maintain/improve data quality, and provide management of clinical data for VRD.

It is your dedication and focus that will help make Pfizer ready to achieve new milestones and help patients across the globe.

ROLE RESPONSIBILITIES

Primary Responsibilities

• Manage the process flow of specific protocol, assay, and biospecimen data for facilitation, review, and implementation on Pfizer Vaccine Clinical Research and Development (VCRD) clinical trials and Medical Development and Scientific/Clinical Affairs (MDSCA) or affiliated research studies.
• Utilize project management expertise to plan and execute multiple projects/ongoing work activities of moderate complexity to ensure successful implementation against the established plans.
• Responsible for collecting information needed for data management plans including data preparation, transcription, verification activities, etc.
• Liaise with and proactively pull together representation from appropriate departments, functions, and Subject Matter Experts (SMEs) regarding information needed for biospecimen analysis/planning, data quality/compliance-related programs, questions, and communications.
• Ensure a robust quality culture and maintain processes to drive high standards of excellence and compliance.
• Promote the use of consistent, efficient, and quality processes to meet timelines and deliverables.
• Ensure work carried out by providers is in accordance with applicable Pfizer Standard Operating Procedures (SOPs), Policies, working practices, and global regulations.
• Foster continuous improvement and develop solutions to address issues and improve data processes and quality metrics, predominantly around transparency of information needed for biospecimen planning.

Biospecimen Analysis & Assay Plan (BAAP) Facilitation

• Gather, organize, process, review, and verify specific protocol, assay, and biospecimen information via interaction with stakeholders to ensure accurate, timely, and consistent data for the clinical database and Trial Master File (TMF) throughout the course of a study. In short, ensure specific protocol details are translated for use downstream by Data Management colleagues.
• Ensure operational excellence in collaboration with partners for application of standards, data acquisition, proactive data review and data integrity, and overall data management activities.
• Provide guidance, lead/co-lead projects, manage own time to meet objectives, and help plan potential resource requirements for projects across the division.
• Serve as liaison to Data Monitoring and Management (DMM), VCRD, and MDSCA colleagues on clinical trials and research studies, assuming responsibility for oversight of biospecimen and assay data activities as it relates to the BAAP.
• Interact with Clinicians, Clinical Data Scientists, Statisticians, Assay Leads, etc. at study level for deliverables.
• Serve as a technical resource to the study teams for data visualization and reporting tools, and provide technical expertise and business process support in technology systems.
• Partner with Data Management and Research Informatics Operations colleagues to ensure high-quality data management is appropriately planned and completed.
• Perform central monitoring activities including review of system outputs, the proposal of suggestions for signal and action management, and follow-up with the study team for the action resolutions.
• Plan and execute communication plans and methods for engaging customer populations.
• Track areas of risk in data quality, compliance, and inspection readiness.
• Analyze data trends and assist in the development and implementation of risk mitigation strategies and continuous improvement activities within VCRD and with partner lines.

QUALIFICATIONS

BASIC QUALIFICATIONS

• Bachelor's degree with a minimum of 8 years related experience in pharmaceutical research quality assurance, compliance, data management, or regulatory fields.
• Master's degree with a minimum of 6 years related experience in pharmaceutical research quality assurance, compliance, data management, or regulatory fields.
• Project Management, Process/Facilitation management experience with demonstrated attention to detail.
• Experience with electronic documentation, product and process specifications, and developing and applying analytical methods to address problem resolution.
• Able to confront and quickly resolve difficult or controversial issues, address conflicts, make timely decisions.
• Experience getting results through influence and collaboration
• Experience with laboratory information systems, MS Office applications, SharePoint sites, TEAMs, and familiarity with use of relational databases or programming languages.
• Strong communication (written and verbal facilitation and presentation skills) with experience interacting with colleagues at all levels of the organization.
• Experience conducting deep data mining.

PREFERRED QUALIFICATIONS

• Quality certification (e.g., RQAP-GCP/GCLP) or project management certification (e.g., PMP)
• Strong knowledge of or experience with ICH, FDA, EMA, and GCP/GCLPs, with an emphasis on clinical processes
• Familiarity with bioanalytical laboratory and standard assay terminology/acronyms

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Candidate may be required to call into meetings and discussions that may have participants from geographical locations around the world, at times that fall outside of the normal 8 AM to 5 PM work hours.

OTHER JOB DETAILS

Eligible for Relocation Package

Eligible for Employee Referral Bonus

#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.

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