(Insourcing) (Sr.) Study Manager

Responsibility:

Responsible for study management for one or more studies from feasibility through database release and inspection as
well as site monitoring and oversight and building and retaining relationships from site activation through the lifecycle
of studies:
1. Study management
• Accountable for conducting country and study level feasibility, review Pre-Trial Assessment (PTA) output to
ensure appropriate site selection in China.
• Provide comprehensive operational input to the protocol design to ensure operational feasibility.
• Accountable for the development of realistic detailed study startup and monitoring plans.
• Develop study level recruitment/retention strategy/plan; oversee implementation of plan, including
site-level plans, recruitment/retention tools, and advertising materials.
• Assess and oversee site activation plans to ensure timely site readiness (Clinical Site Agreements, Ethics
Committee approvals and regulatory documentation.)
• Provides ongoing assessment of subject enrollment / discontinuations to inform accurate forecasting
for financial planning.
• Generate study/country level ICD and review site level ICD as appropriate.
• Accountable for the delivery of the study against approved plans.
• Coordinates study/protocol training& investigator meeting.
• The Study Manager will be the technical expert for study management systems and processes.
• The Study Manager will champion the implementation and use of harmonized, consistent processes and
excellence in Study Management deliverables related to cost-effective, timely, and high-quality clinical trial data
according to agreed global goals.
• Accountable for HGRAC submission package preparation by working with HGRAC taskforce team.
• Help to address Significant Quality Events or other quality issues at patient/site level.
2. Site monitoring and oversight
• Monitor site performance using appropriate tools and resources (e.g., study metrics, site health, Risk based
monitoring etc.) and take appropriate mitigate actions.
• Lead risk assessment at the site/country level for their studies, including identifications of mitigation and
control.
• Conduct and report oversight activities, both remote and onsite visits, according to Pfizer requirements and
standards.
• Perform additional oversight visits/reviews based on the type of issues that arise during the course of a study,
and the analytics and visualizations outputs.
3. Budget
• Develops and provides key inputs to Clinical Trial Budget (CTB) (e.g., Per Subject Costs- PSCs).
• Responsible for study budget phasing and tracking.
• Develop study and country level CSA template and review and approve Site CSA/contracts.
• Review and approve payments to investigators and vendors.
4. Drug Supply
• Collaborate with Supply Chain Lead to develop and complete the Request for Clinical Supplies.
• Work with the Supply Chain Lead to ensure that clinical trial drug supplies are ordered, produced,
labeled and supplied in a timely manner.
• Approves & oversees drug supply management – manages flow of drug supply to the sites & set up Integrated
Voice Response System (IVRS) with Supply Chain Lead.
5. Inspection/audit Readiness
• For study-specific audits and inspections, the study manager can serve as a resource to the study team to
facilitate the facilitate the audit/inspection.
• Leads inspection readiness activities related to study management and site readiness.
• May support study level submission readiness.

Minimal/Must-have Requirement

Qualifications:
• Minimum of BS/BA in a biomedical discipline or equivalent education/training is required
• At least 5 years in clinical practices
• Good working knowledge of Good Clinical Practices (GCPs), monitoring, clinical drug development process and
country regulatory environment
• Experience with clinical research methodology (e.g., study design, study monitoring and data
analysis). Prior study management and/or study coordination experience preferred.
• Demonstrated effectiveness in working in a multidisciplinary, matrix team situation.
• Advanced education and/or training/experience desirable.
Skills:
• Extensive knowledge of clinical development process including in depth knowledge and understanding of the
principles of GCP.
• Knowledge of the clinical development process, understand concepts and principles of
study design, and application to manage and run studies.
• Knowledge of global and local regulatory requirement, disease and technical areas pertaining to clinical studies.
• Ability to manage studies and processes to agreed quality and timelines.
• Ability to proactively identify & mitigate risks around study/site level in study execution.
• Keen problem-solving skills.
• Effective verbal and written communication skills in relating to colleagues and associates both inside
and outside the organization.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.