Pfizer Manager, Clinical Scientist in Pearl River, New York
Why Patients Need You
Pfizer's purpose is to deliver breakthroughs that change patients' lives. Research and Development is at the heart of fulfilling Pfizer's purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best-in-class medicines to patients around the world.
As a Manager, Clinical Scientist you will provide medical and scientific study and project support for multiple, global, Phase 1-4 vaccine clinical studies in a clinical program. In this role, you will be responsible for working collaboratively with Sr. Manager and/or Lead Clinical and will develop study strategies in support of the clinical plans.
You will represent Vaccine Clinical Research and may participate in company-wide, global process improvement initiatives, and champions process enhancements and solutions for moderate to complex issues.
1) PROTOCOL AND STUDY DESIGN
Provide specific medical/protocol training for site facing roles
Complete clinical sections of the Site Reference Manual
Create informed consent form templates, and review site prepared ICFs
Support the preparation of other clinical documents as required
2) DATA REVIEW AND INTERPRETATION
Provide clinical input for and participate in study set up and design including data collection tools, data analysis, and database set-up.
Proactively coordinate with Clinical Scientists and Lead Clinician to assure understanding and agreement on deliverables throughout the process
Provide input for the design of the Statistical Analysis Plan (SAP) and the clinical data output
Responsible for review of patient level data across a study and for coordinating with Lead Clinician for study level review as delegated
Responsible for ensuring consistency across Pfizer and Vendor systems with clinical study database
Review study protocol deviations and ensure they are correctly and consistently reported and captured in the database
Collaborate with Pfizer VRD laboratory personnel to ensure sample collection process is implemented correctly in the study
Participate in study analysis and decision point preparation including interim analysis, stopping rules, DMC and DSMB management
Interpret data and identify issues of simple/moderate complexity in the data
Independently prepares efficient plan for medical review of data and moderates data review independently
3) STUDY MEDICAL OVERSIGHT
Collaborates with the Lead Clinician to provide medical/scientific guidance during the execution of the study
Provides medical/scientific perspective in consultation with the CPM during the development of the monitoring plan
Answers specific site management protocol questions as needed
Assists in medical/scientific issue resolution (study wide, escalated regional/site)
Provides input during vendor selection for specific medical/protocol issues
Track and reconcile SAEs across a study
Report SAEs during Safety Review Team meetings
Ensure timely communication of safety issues to sites
Review and approval of patient narratives as delegated by the Lead Clinician
5) REGULATORY AND PUBLICATIONS
Provide in-depth scientific/medical input, review and editing of clinical study reports (CSR)
Provide review of publications
Prepares audit responses as delegated by the Lead Clinician
Participates in inspection readiness activities
6) CLINICAL PROGRAM IMPLEMENTATION
Along with Study and Lead Clinical Scientists and the Lead Clinician, participates in the Medical/Safety/Scientific Design and Execution of a Study, with oversight of Clinical Research Organisations and vendor activities.
Ensure regulatory compliance and GCP adherence at the study level with regard to medical/scientific issues
Initiate and coordinate corrective action for medical/safety/scientific study level issues
Along with CPM and with regard to medical/safety concerns, ensures study level issues are resolved
Coordinates with CPM to maintain study timelines.
Along with the CPM and in agreement with the Clinical Program Lead/Lead Clinician and the Team, develops study level enrollment plan
Along with the CPM and other study team members, participates in development of training strategy, provides input into preparation of study level training materials, and participates in training of Study
Management Staff and monitoring staff.
In collaboration with the CPM and study team, ensures the clinical trial material requirements of the study are met
Ensure standard processes, tools, and procedures used consistently and globally
Provide input into the monitoring plan for study
Ensure execution of the global study management plan from a medical/safety/scientific perspective
BA/BS Degree in science or health-related field and 12+ years relevant experience in vaccine therapeutic area
Comprehensive knowledge of the clinical research process and Good Clinical Practices from previous employment experience and/or education in the clinical research field
Has demonstrated ability with integrating and summarizing medical/scientific concepts in protocols and other clinical documents
Has experience with co-leading and/or participating in an operational team
Has ability to work independently with instruction primarily on unusual or complex problems
Has working knowledge of statistics, data analysis, and data interpretation
Has exceptional written and oral communication and cross-functional collaborative skills
Proficient in MS Word, Excel, and PowerPoint
MS and 9+ years relevant experience, or PhD or PharmD and 4+ years of experience
Work location: On premise
Relocation support available
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.
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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