• Create protocol training materials for site management
• Provide specific medical/protocol training for site facing roles including monitors and Study Managers
• 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 Study Team Leads (CSTLs), Statisticians, and other relevant groups.
• Lead strategy discussions of moderate complexity
• Create informed consent document templates, and review site prepared ICDs
• Support the preparation of other clinical documents as required

• 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
• Independently prepares efficient plan for medical review of data and moderates data review independently

• Collaborates with the Lead Clinician to provide medical/scientific guidance during the execution of the study
• Provides medical perspective in consultation with the CSTL 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

• 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

• 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

• 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 CSTL and with regard to medical/safety concerns, ensures study level issues are resolved.
• Collaborate with Lead Clinician and CSTL 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 CSTL to maintain study timelines.
• Along with the CSTL and in agreement with the Clinical Program Lead/Lead Clinician and the Team, develops study level enrollment plan
• Along with the CSTL and other study team members, participates in training of Study Management Staff and monitoring staff.
• In collaboration with the CSTL 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 CSTL and team members

• 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

• 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
• Has ability to work independently
• 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 Power Point
• Fluency in Mandarin desirable

Work Location Assignment: Hybrid

• Paid parental leave
• Access to Health & Wellness apps
• Career Growth Experiences program
• Recognition & rewards program
• Paid volunteer days
• Life Insurance Benefits
• Pfizer Learning Academy access to top content providers
• Access to flu vaccines & skin checks
• Options to purchase additional leave
• Salary packaging & novated lease options

• Benefits listed may vary depending on your position and location and may be subject to change.

Medical