Study Manager III (Director) - Oncology
- The Study Manager has responsibility for all study management aspects of assigned studies.
- The Study Manager leads and manages the tactical execution of one or more large and/or highly complex (multiple numbers of countries and sites with a large number of subjects and/or high number and complexity of vendors and/or novel or rare patient population) clinical studies from study startup through database release.
- The Study Manager provides quality oversight to the Clinical Research Organization (CRO) and of the CRO deliverables related to study execution.
- The Study Manager leads and coordinates the execution of a clinical trial from Sourcing Strategy and Study Specification development for Requests for Proposals, Study start-up through Database release and inspection readiness to ensure timely delivery of quality study data. Study Managers may also input to and support compilation of sections to Clinical Study Reports and provide program-level insights.
- The Study Manager will provide 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 (partners with cross functional GSSO colleagues and/or CRO to support global trial start up) and monitoring plans and delivery to the agreed plans.
- The Study Manager is a critical member of the Core Team and will represent the CRO, GSSO, and applicable vendors on matters of study execution.
- The Study Manager works with functional lines and directly with CRO line functions to resolve or triage site-level issues.
- The Study Manager will drive decision making and work closely with the Clinical Study Team Lead (CSTL) to provide input to operational strategy.
- For studies where more than one Study Manager is assigned acts as Lead Study Manager and will coordinate activities of the other Study Managers assigned.
- Is required to provide oversight and/or mentorship to other study managers, as necessary.
- The Study Manager monitors vendor contracts for out of scope activities and budget spend/invoices for assigned vendors (e.g., central labs, CRO, electronic Patient Reported Outcomes [ePRO], radiology, etc.).
Responsible for Study Management and oversight of all Study Management functions internally and at the CROs
Operational Study Management
- Accountable for the development of realistic detailed study startup and monitoring plans, including Sourcing Strategy, input into Requests for Proposals, and for the selection of the CRO.
- Accountable for conducting country-level feasibility in collaboration with cross functional GSSO colleagues, reviewing Pre-trial Assessment outputs, approving sites, and assessing site activation plans.
- Leads study risk planning process in the context of site and subject
- Co-ordinates study/protocol training & investigator meetings
- Develops and provides key inputs to Clinical Trial Budget (e.g., Per Subject Costs)
- Responsible for monitoring the budget and contracts for assigned vendors (e.g., central labs, CRO, ePRO, radiology, 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
Study Management Oversight
- Approves the Study Startup, Study Monitoring & protocol recruitment plans and others (e.g., CRF Guidelines, IMPALA manual, Training Plan, etc.)
- Approves & oversees drug supply management – manages flow of drug supply to the sites & set up Interactive Randomization Systems with Supply Chain Lead.
- Reviews consolidated Pre-trial Assessment reports, feasibility outputs, etc. in partnership with cross functional GSSO colleagues.
- Supports study level submission readiness.
- Will Participates in vendor UAT and system set-up requirements review and approval (e.g., IRT, Central Lab).
Study Team Interface
- Leads and oversees all elements of study startup and monitoring functions both internally and at the CROs 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 CRO and data management functions to ensure alignment on data flow and timely delivery.
- 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, CRO, ePRO, radiology, etc.).
- Provides ongoing assessment of subject enrollment/discontinuations to inform accurate forecasting for financial planning.
- Provides operational input into protocol design.
- Leads Protocol Deviation review and reconciliation partnering with Clinical.
- Lead and facilitates the routine study management vendor calls.
Subject Matter Expertise
- 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.
- The Study Manager will be responsible for the technical oversight of the CRO to include but is not limited to standards, continuous improvement, issue escalation/resolution, inspection readiness/quality assurance, performance feedback, review of metrics.
- The Study Manager partners with CRO Managers to proactively identify and resolve study operations staff performance issues.
- For project-specific audits and inspections, the Study Manager serves as a resource to the study team to facilitate the audit/inspection.
- Able to act as an SME on projects and initiatives, as requested.
Training and Education
- 10+ years of clinical research experience and/or study management experience.
- Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations.
- BS/Nursing Degree – a minimum of 7 years of relevant experience.
- MS/Ph.D. – minimum of 5 years of relevant experience.
- Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.Medical