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Clinical Scientist Vaccine Clinical Studies

Location
Collegeville, PA

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Clinical Scientist, Vaccine Clinical Studies
Pfizer

Collegeville
PA
Job #714804681
Clinical Scientist
The Clinician, Clinical Scientist (CS) will provide medical and scientific study and project support for multiple, global, Phase 1-4 vaccine clinical studies in a clinical program. They are responsible for working collaboratively with the Clinical Lead Physician and Lead Study Clinician Physicians and will develop study strategies in support of the clinical plans. The CS support includes multiple tasks within the categories of: 1) protocol and study design, strategy, and training, 2) data review and interpretation, 3) study and/or program scientific and integrity oversight, 4) safety review and communication, 5) regulatory document, study report and publication preparation and review, and 6) clinical study implementation oversight, with a critical focus on consistency, quality, data integrity, safety, and alignment with company values. The CS may be assigned to lead implementation of program level activities identified by the Lead Clinical Scientist and Clinical Lead Physician as needed.
Responsibilities:
1) PROTOCOL AND STUDY DESIGN
Create protocol training materials for site management
Provide specific medical/protocol training for site facing roles
Provide site medical/protocol training for use during site initiation visits
Provide protocol training at the investigator meeting
Assist in preparation for and participate in consultant and key opinion leader meetings
Complete clinical sections of the Site Reference Manual
Provide input on country feasibility as delegated by the Clinical Program Lead and/or Lead Clinician
Independently write/design protocol outlines, protocols, and amendments of moderate complexity in collaboration with the Lead Clinician, Clinical Project Management (CPM), Statisticians, and other relevant groups including Clinical Research Organizations
Lead strategy discussions of moderate complexity
Create informed consent form templates, and review site prepared ICFs
Support the preparation of other clinical documents as required
2) DATA REVIEW AND INTERPRETATION
Lead clinical input for and participate in study set up and design including data collection tools, data analysis, and database set-up
Proactively coordinate with the 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
Lead or participate in study analysis and decision point preparation including interim analysis, stopping rules, DMC and DSMB management
Interpret data and identify issues of moderate/difficult complexity in the data
Provide protocol training at the investigator meeting
Assist in preparation for and participate in consultant and key opinion leader meetings
Complete clinical sections of the Site Reference Manual
Provide input on country feasibility as delegated by the Clinical Program Lead and/or Lead Clinician
Independently write/design protocol outlines, protocols, and amendments of moderate complexity in collaboration with the Lead Clinician, Clinical Project Management (CPM), Statisticians, and other relevant groups including Clinical Research Organisations
Lead strategy discussions of moderate complexity
Create informed consent form templates, and review site prepared ICFs
Support the preparation of other clinical documents as required
3) STUDY MEDICAL OVERSIGHT
Collaborates with the Lead Clinician to provide medical/scientific guidance during the execution of the study
Provides medical perspective in consultation with the CPM during the development of the monitoring plan
Answers specific site management protocol questions as needed
Assists in medical issue resolution (study wide, escalated regional/site)
Provides input during vendor selection for specific medical/protocol issues
4) SAFETY
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 full review of content and integrates information from literature and other sources as appropriate.
Support and contribute to various sections of regulatory filings (Pediatric Investigational Plan ,IB, IND/NDA Annual Reports, and PSURs and Regulatory authority responses)
Participate with the Clinical Program Lead and publications team to determine publication strategies
Prepares audit responses as delegated by the Lead Clinician
Participates in inspection readiness activities
6) CLINICAL PROGRAM IMPLEMENTATION
Along with the Lead Clinician is accountable for 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 major medical/safety/scientific study level issues
Along with CPM and with regard to medical/safety concerns, ensures study level issues are resolved.
Collaborate with Lead Clinician and CPM to arrive at major site level decisions based on input from the team
Provide input during budget creation to Clinical Program Lead and Lead Clinician
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 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
Participates in developing training strategy for study with the study team members.
Provide input into the preparation of study level training materials in collaboration with CPM and team members
Provide input into the monitoring plan for study
Provide scientific and medical /technical support to ensure that monitoring plan addresses unique vaccine-specific activities supporting the endpoints of the trial
Ensure execution of the global study management plan from a medical/safety/scientific perspective
Required Qualifications and Experience:
BA/BS Degree in science or health-related field MS, PhD or Pharm D preferred
Has extensive knowledge of the clinical research process and Good Clinical Practices from previous employment experience in the clinical research field
Has working knowledge of vaccine therapeutic area
Has demonstrated ability and level of experience with integrating and summarizing medical/scientific concepts in protocols and other clinical documents
Has independently authored clinical protocols and other clinical study documents
Has experience with participating in and informally leading an operational team
Applies knowledge of internal/external business challenges to facilitate process improvements
Ability to work independently with minimal supervision
Has 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
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
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.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Updated 08/11/2018

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