Job Description:
- 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.