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 IC - Fs. 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 Clini... more details
The Manager, Clinical Scientist (CS) will provide medical and scientific technical expertise and support for global Phase 1-4 vaccine clinical studies. They are responsible for working collaboratively with Sr. Manager and/or Lead Clinical Scientists, and Study Clinicians to provide CS support to moderately complex tasks within the categories of: 1) protocol and study design, 2) data review and interpretation, 3) study scientific and integrity oversight, 4) safety review and communication, 5) study report, publication, and audit response input and review, inspection readiness preparation and 6) clinical study implementation oversight, with a critical focus on consistency, quality, data integrity, safety, and alignment with company values.
Roles and Responsibilities
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
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 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 Organizations 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 managementplan from a medical/safety/scientific perspective
7) Represents Vaccine Clinical Research and may participate in company-wide, global process improvement initiatives, and champions process enhancements and solutions for moderate to complex issues
Qualifications
BA/BS Degree in science or health-related field and 5 years relevant experience,
MS and 3 years relevant experience, or PhD or Pharm D preferred
- Has comprehensive knowledge of the clinical research process and Good Clinical Practices from previous employment experience and/or education in the clinical research field
- Ideally has some working knowledge of vaccine therapeutic area
- 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
- Is proficient in MS Word, Excel, and PowerPoint
PHYSICAL/MENTAL REQUIREMENTS
Position requires sitting and some travel and ability to review/analyze large complex clinical data sets. Expert at working in a changing environment.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Some travel may be required. Weekend and evening work may be required based on project needs.
Work Location Assignment: Flexible
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Minimal travel
Work Location Assignment: On Premise
The annual base salary for this position ranges from $99,900.00 to $166,500.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
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. This position requires permanent work authorization in the United States.
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