Japan Study Manager

JOB SUMMARY

• Responsible for in country study/site management and clinical/scientific oversight activities of assigned clinical trials to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and Pfizer standards.
• Provides quality oversight to the CRO and of the CRO deliverables related to study execution. Leads and coordinates the execution of a clinical trial from Study start-up through Database release and inspection readiness to ensure timely delivery of quality study data. Provides leadership to the teams in the setting of realistic recruitment targets and delivery milestones as the single point of accountability for detailed study start-up and monitoring plans and for delivery to the agreed plans.
• Act as core member of the Study Team and will represent the CRO on matters of study execution.
• Accountable for managing investigator site relationships to ensure effective delivery of clinical trials (e.g., study start up, enrollment, database release), to safeguard the quality of investigator sites (e.g., site health, patient safety) and to maintain investigator and study coordinator engagement and satisfaction.
• Acts as local expert for the assigned clinical trials and brings that expertise to support the investigator site, which includes the investigator, study coordinator, pharmacist etc, and to oversee and support the site monitor in the conduct of clinical trials. This role is responsible for the resolution of protocol-related issues at the local level.
• Ensure timely communication with bidirectionally between global and local study team

JOB RESPONSIBILITIES

Responsible for country study/site management and clinical/scientific oversight for assigned studies:

• Responsible for Country Study Management
• Counterpart of Global Study Manager to manage studyin country
• Accountable for effective site recruitment planning and delivery, and resolve critical issues at site level as face of Pfizer in the study and conducts oversights for investigator sites
• Leads and oversees all elements of study startup and monitoring functions both internally and at the CROs to ensure delivery & compliance with all applicable SOPs and Quality Standards, interfacing directly with CRO to determine Feasibility/Study Startup, Monitoring Groups
• Accountable for the development of realistic detailed study startup and monitoring plans
• Accountable for conducting country level feasibility, reviewing PTA outputs, approving sites, and assessing site activation plans
• Works proactively with CRO and data management functions to ensure alignment on data flow and timely delivery
• Reviews consolidated PTA reports, feasibility outputs, etc.
• Shares and escalates plan deviations to Clinical Project Manager (and study team)
• Leads study risk planning process in context of site and subject
• Approves & oversees drug supply management – manages flow of drug supply to the sites & set up IVRS with Supply Chain Lead
• Coordinates study/protocol training & investigator meetings
• Develops and provides key inputs to CTB (e.g., PSCs)
• Provides ongoing assessment of subject enrollment/discontinuations to inform accurate forecasting for financial planning
• Provides operational input into protocol design
• Accountable for the delivery of the study against approved plans
• Acts as technical expert for study management systems and processes. Acts as 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.
• Responsible for the technical oversight of the CRO to include but is not limited to: mentoring, standards, continuous improvement, issue escalation/resolution, inspection readiness/quality assurance, performance feedback, review of metrics.
• Partners with Monitoring Lead to proactively identify and resolve study operations staff performance issues.
• For project-specific audits and inspections, serves as a resource to the study team to facilitate the audit/inspection.
• Leads inspection readiness activities related to study management and site readiness
• May support study level submission readiness
• May produce or review model Informed Consent Document (ICD) and study/country/site level ICD, as appropriate
• May expand study design document into approved protocol template while incorporating input from other team members (e.g., Clinician, Clinical Pharmacology Lead, Supply Chain Lead, Statistician, Outcomes Research Representative, Clinical Assay Group,etc.)

Site Management & Delivery:

• Provide recommendations on potential sites and provide targeted follow up with key sites as required.
• Oversee and support study start up activities at the country level, including review of key documents (e.g., local Informed Consent Document template), and providing support to address regulatory and/or ethics committee questions.
• Oversee and support study start up activities at the site level, including management of emerging issues that may compromise time to site activation.
• Provide enrollment support and ensure progress by responding to start-up and recruitment issues from investigators, partner with study team to define and support recruitment initiatives at site/country level
• Lead effective site recruitment planning and implementation of plans at site level, consistent with global plan and local specificities.
• Support database release as needed.

Clinical/Scientific Oversight:

• Exerts proactive in ensuring overall site quality, regulatory and GCP compliance.
• Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators and site monitors.
• Provide protocol training to, and address protocol related questions from, the investigator site staff, site monitor and other SMs when required. This may include attendance at investigator meeting and/or site initiation visits and should involve discussions on known/anticipated operational and clinical risks
• Create and manage the study site risk plan (the study oversight plan) and mitigate for known/anticipated risks proactively
• Monitor site performance using appropriate tools and resources (e.g., metrics, site health, Risk Based Monitoring signals etc.) and take appropriate targeted action.
• Apply knowledge of data and analytics to target site, study and asset level actions for mitigation and control.
• Conduct and report oversight activities, both remote and onsite visits according to Pfizer standards.
• Proactively identify, manage and escalate site issues.
• Help to address Significant Quality Events or other quality issues at patient and/or site level.
• Ensure resolution of investigator site issues in order to maintain sound investigator relations.
• Communicate with investigators and study coordinators on a regular basis to build and maintain productive relationships and support investigator engagement through scientific discussion.
• Provide support for site audits/inspections as needed.
• Maintain a thorough knowledge of assigned protocols.

Study Team Interface:

• Interface with the study team as needed and act as representative of the SM function.
• Champion and ensure update of existing tools/processes related to clinical site selection and management
• As needed, facilitate the exchange of information to/from the study team on study progress and impact of local clinical development environment on study/site

Country/Regional Environment Management and Across Study Trends:

• Provide regional and cross-regional insights on trends (e.g., study/asset level issues, cultural differences, evolving local regulatory environment etc)
• Maintain a thorough knowledge of country/regional clinical trial regulations and country/regional clinical development environment

QUALIFICATIONS / SKILLS

Training and Education Preferred:

• Study management and site management experience
• Working knowledge of GCPs, monitoring, clinical and regulatory operations
• BS – minimum of 4 years relevant experience
• MS/PhD – minimum of 2 years relevant experience

Language:

• Excellent writing and communication skills in both Japanese and English is required.

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