Global Study Manager 2 at Pfizer

Role Summary

• Global Study Managers provide operational leadership throughout the study lifecycle, with accountability for oversight and execution of study management, site management, preferred CRO (pCRO) and vendor deliverables for all Study Management deliverables in a study.
• The Global Study Manager has exceptional knowledge within the organization for Study Management processes and deliverables. Additionally, the Global Study Manager will maintain expertise within their assigned Therapeutic Area and study in order to set the appropriate strategy, identify risks and to drive operational deliverables. The Global Study Manager will have good knowledge in understanding the responsibilities beyond their function in order to ensure goals are met for the study.

Leads engagement and coordination of appropriate key partners:

• The Global Study Manager leads and coordinates the execution of a clinical trial globally from Sourcing Strategy and Study Specification development for Requests for Proposals for fully outsourced studies and ancillary vendors, Study start-up through Database release and inspection readiness to ensure timely delivery of quality study data. Global Study Managers may also provide input to and support compilation of sections to Clinical Study Reports as needed.
• The Global Study Manager at this level develops ideas and can lead some complex projects.
• The Global Study Manager provides quality oversight and coordination of regional/country operations and pCRO for the tasks both owned by and delegated to Study Operational Managers (if assigned to study) related to study execution.
• The Global Study Manager will provide leadership to the teams in setting recruitment targets and delivery milestones as the single point of accountability for detailed study start-up (partners with cross functional GSSO colleagues, CD&O colleagues and other functions) and monitoring and other study level plans and delivery to the agreed plans.
• The Global Study Manager is a critical member of the Core Team and will represent the operational sub-team including GSSO applicable vendors and pCRO on matters of study execution.
• The Global Study Manager works with functional lines and directly with other GSSO line functions and pCRO to resolve or triage site-level issues.
• The Global Study Manager will drive decision making and work closely with the Clinical Study Team Lead (CSTL) to provide input to operational strategy.
• The Global Study Manager leads the Operational Sub team and leads engagement and coordination of appropriate key partners, GSSO, pCRO, Study Operational Managers (if assigned) and study management vendors through the study lifecycle to ensure timely delivery and quality of study management deliverables.
• The Global Study Manager is required to provide supervision and/or mentorship to Study Operational Managers and possibly other Global Study Managers.
• The Global Study Manager monitors vendor contracts for out-of-scope activities and budget spend/invoices for assigned vendors (e.g., central labs, electronic Patient Reported Outcomes [ePRO], radiology, etc.).
• The Global Study Manager is responsible to ensure development of study level plans (Study Monitoring Plan, Study Training Plan, etc).
• The Global Study Manager is responsible to review study level metrics and analytics and ensure appropriate actions are taken to mitigate risks and resolve issues.
• The Global Study Manager can work independently and can demonstrate resourcefulness.
• The Global Study Manager may need to on occasion take on the role and responsibilities of a Study Operational Manager

ROLE RESPONSIBILITIES

• Accountable for Study Management and oversight of all Study Management functions Operational Study Management

Operational Study Management

• Responsible to form, oversee and lead the operational sub team and request resources as needed
• Accountable for the development of realistic detailed study startup and/or study management strategy and monitoring plans, including Sourcing Strategy, input into Requests for Proposals, and for the selection of vendors
• Accountable for ensuring country-level feasibility is completed in collaboration with cross functional GSSO colleagues and Operational Analytics & Quantitative Sciences (OAQS) organization and pCRO (as applicable) reviewing Pre-trial Assessment outputs, approving sites, and assessing site activation plans
• Accountable and responsible to ensure PTMF setup for Study management and Country/Site level documents
• Inputs into the IQMP risk planning process for the study
• Coordinates development of study/protocol training & global investigator meetings.
• Accountable to ensure local Investigator meetings are coordinated by the Study Operational Manager (if assigned to study) and as applicable
• Develops and provides key inputs to Clinical Trial Budget (e.g., Per Subject Costs)
• Accountable to ensure Study Operational Managers are inputting into the budget for local/country level tasks (if assigned). The Global Study Manager will ensure cost variance, invoices, POs, etc. are reviewed in a timely manner ensuring spend is appropriate and on track with the forecast.
• Responsible for monitoring the budget and contracts for assigned vendors (e.g., central labs, ePRO, radiology, pCRO, etc.).
• Accountable for the delivery of the study against approved plans
• Leads inspection readiness activities related to study management and site readiness
• Support development and delivery of decentralized capabilities at investigator sites
• The Global Study Manager if assigned to study post database lock will ensure timely study closure and release of internal and external resources as appropriate.

Study Management Oversight

• Development, review or approval of the Study Startup, Study Monitoring & protocol recruitment plans and others (e.g., CRF Guidelines, IMPALA manual, Training Plan, etc.) The Global Study Manager can delegate development of plans or components of plans to Study Operational Managers (if assigned) or CSTAs as appropriate.
• Approves & oversees drug supply management – manages flow of drug supply to the sites & set up Interactive Randomization Systems with Supply Chain Lead
• Accountable to ensure overall vendor oversight for vendors managed by Study Operational Managers (if assigned), action escalations related to vendor issues and escalate further as necessary
• Reviews consolidated Pre-trial Assessment reports, feasibility outputs, etc. in partnership with appropriate cross functional colleagues
• May support study level submission readiness
• May participate in vendor UAT and system set-up requirements review and approval (e.g., IRT, Central Lab)
• Responsible to ensure applicable system closure at study completion

Study Team Interface

• Leads and oversees all elements of study startup and monitoring functions to ensure delivery & compliance with all applicable Standard Operating Procedures (SOPs) and Quality Standards, interfacing directly with CRO Feasibility / Study Startup, Monitoring / Management & Site Contracting Groups
• Works proactively with data management functions and GSSO colleagues to ensure alignment on data flow and timely delivery. Regular review of data reports and dashboards to identify risks and drive appropriate actions.
• Shares and escalates plan deviations to Clinical Study Team Lead (and study team) and drives/oversees mitigations
• Review vendor expenses and WO as per study budget for assigned vendors (e.g., central labs, ePRO, radiology, pCRO etc.).
• Provides ongoing assessment of subject enrollment/discontinuations to inform accurate forecasting for financial planning
• Provides operational input into protocol design
• Leads Protocol Deviation trend review partnering with Clinical
• May lead and facilitates the routine study management vendor calls

Subject Matter Expertise

• The Global Study Manager will be the technical expert for study management systems and processes
• The Global 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.
• The Global Study Manager will be responsible for the technical oversight of the operational sub team to include but is not limited to standards, continuous improvement, issue escalation/resolution, inspection readiness/quality assurance, performance feedback, review of metrics.
• The Global Study Manager partners with the operational sub team and pCRO to proactively identify and resolve study operations staff performance issues.
• For project-specific audits and inspections, the Global Study Manager can serve as a resource to the study team in addition to the Study Operational Manager(s), if assigned, to facilitate the audit/inspection.

Basic Qualifications

Training and Education

• Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations
• A scientific or technical degree is preferred along with extensive knowledge of clinical trial methodology
• BA/BS 7+ years of relevant experience
• MBA/MS/ 6+ years of relevant experience

English is required.

Prior Experience

• Demonstrated clinical research experience and/or study management experience
• Demonstrated study management/leadership experience
• Demonstrated oversight of CROs/vendors
• Demonstrated experience in managing per subject costs, vendor & ancillary, and monitoring costs projections & spend

Skills

PREFERRED QUALIFICATIONS

• Requires exceptional knowledge of own discipline and advanced knowledge of others and applies these skills to ensure a Sub Business Unit/Sub Operating Unit meets its goals
• Creates an environment where innovation is standard taking appropriate risks to advance innovative processes
• Develops ideas and leads complex projects across Sub Business Unit/Sub Operating Unit
• Develops innovative solutions to complex problems impacting a Sub Business Unit/Sub Operating Unit
• Exercises own judgment and is a resource for others. Works independently with assignments often self-initiated