Study Manager (Insourced to MNC)

• 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.
• 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.
• 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.
• 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.
• 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"

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.