Clinical Development Scientists Vaccines (Manager)
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Job Location:
Pearl River, NY - USA
Monthly Salary:
$ 106000 - 176600
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
POSITION SUMMARY
You will provide clinical and scientific support for global Phase 14 vaccine clinical studies within the Vaccines portfolio. Working in close partnership with clinical colleagues you will contribute to study design clinical data review safety oversight and scientific integrity across assigned studies.
POSITION RESPONSIBILITIES
Maintains current scientific and clinical knowledge in the specific disease area(s) of assignment.
Supports development of protocols informed consent documents and studylevel clinical documentation with oversight from clinical colleagues.
Provides input into study setup activities including data collection tools database design considerations and clinical data outputs.
Reviews and queries clinical study data in line with the clinical data review strategy.
Reviews reports and manages protocol deviations.
In partnership with medically qualified colleagues supports ongoing safety review activities.
Contributes to the review of clinical study reports regulatory responses publications and audit or inspection readiness activities.
Collaborates effectively with Clinical Operations Data Management Statistics Regulatory Medical Writing and external partners (e.g. CROs vendors) to ensure timely compliant study delivery.
Ensures trial master file (TMF) compliance for clinical documents.
Follows relevant SOPs regulations and training requirements; supports continuous improvement initiatives by identifying opportunities to enhance processes quality or efficiency within established governance.
REQUIRED QUALIFICATIONS
BA/BS Degree in a science or health-related discipline and a minimum of 4 years of relevant clinical and data experience OR
MS Degree in a science or health-related discipline and a minimum of 2 years of relevant clinical and data experience OR
PhD in a science or health-related discipline
Comprehensive knowledge of the clinical research process and Good Clinical Practices from previous employment experience and/or education in the clinical research field
Experience integrating and summarizing medical/scientific concepts in protocols and documents
Experience participating in and/or co-leading an operational team
Working knowledge of statistics data analysis and data interpretation
Exceptional written and oral communication and cross-functional collaborative skills
Proficient in MS Word Excel and PowerPoint
PREFERRED QUALIFICATIONS
Comprehensive knowledge of the clinical research process and Good Clinical Practices from previous employment experience and/or education in the clinical research field
Vaccines therapeutic area work experience
WORK LOCATION ASSIGNMENT: This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week.
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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Required Experience:
Manager
About Company
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