The Director/Supervisor of Study Management will provide managerial oversight to study management colleagues in their respective groups and their associated deliverables including ensuring oversight of CROs and Vendors. S/he is responsible for the talent development of colleagues and preparing Study Managers to deliver on studies.
The Director/Supervisor of Study Management is accountable to ensure all their direct reports are appropriately trained. They are accountable to ensure study managers are following Pfizer SOPs and providing leadership and appropriate oversight to the CROs.
They are accountable to ensure that Study managers are delivering according to agreed plans and to ensure appropriate proactive escalation of risks and deviations to plans.
The Director/Supervisor of Study Management will use Operational Metrics, Study Plan variance and trend reports to support the oversight and management of both the study managers and CROs.
The Director/Supervisor of Study Management will also interface with CRO managers to resolve issues and escalate resource concerns.
In addition to the management of other Study Managers, the Director/Supervisor of Study Management may be required to perform the role of a Study Manager. The Director/Supervisor of Study Management is a Subject Matter Expert (SME) on study management processes and works with their Study Management Group Lead to facilitate the sharing of therapeutic/functional area expertise and best practices within their group and where applicable across the Study Management organization.
Roles and Responsibilities
- Partners with Study Management Group Lead on defining & providing managerial leadership of strategies within group and specific implementation of processes, quality goals and standards
- Actively develops talent through providing focused career development, performance management & manages retention
- Responsible for the development and adherence to consistent harmonized processes and high quality clinical trial deliverables for clinical projects
- Create, maintain and assume accountability for a culture of high quality and customer service using tools to facilitate communication, transparency of operations, clarity of workload balance, and alignment within and across functional lines
- Support and continuously evaluate and evolve the Study Manager role to add value and efficiencies to internal study management
- In strong collaboration withothercolleagues or functions (peers, project leads, and group leads):
- Contributes to and/or leads cross departmental initiatives
- Implements strategies to ensure consistent processes
- Leads and/or participates in specific process improvement initiatives; monitors and reports on implementation progress as appropriate
- They will be the experts on the study management related SOPs. They are expected to serve as a Study Management SMEs on BPIs and SOP development/update projects. They should proactively share best practices across CD&O.
- Works with sourcing partner/ resourcing lead to ensure provision of technically trained Study Managers per sourcing strategy
- The MSM will be the main interface for the CPMs for issue escalation, SM performance issues and to discuss resource demand and for specific study resource requests.
May also be required to fulfil the role of a Study Manager in addition to oversight and supervisory responsibilities, this would include :
- 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 / Management & Site Contracting 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
- Approves the Study Startup, Study Monitoring & protocolrecruitment 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
- The SM will be the technical expert for study management systems and processes
The SM 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 SM will be 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.
The SM partners with CRO Managers to proactively identify and resolve study operations staff performance issues.
For project-specific audits and inspections, the SM can serve 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.)
Training and Education:
- Extensive global clinical trial/study management experience
- Working knowledge of GCPs, monitoring, clinical and regulatory operations
- BS – minimum of 10 years relevant experience
- MS/PhD – minimum of 7years relevantexperience
- Demonstrated study management / leadership experience
- Evidence of Clinical Development and pharmaceutical study execution experience; thorough understanding of the processes required to operationally execute clinical trials is preferred
- Demonstrated experience in managing PSC, vendor & ancillary, and monitoring costs projections & spend
- Experience in leadership, study management, resource management (staff and financial) is required
- direct study management expertise required
- demonstrated supervisory responsibilities
- Experience in therapeutic / functional area of expertise desirable.
- Experience in the management and direct supervision of internal resource required
- Demonstrated effectiveness working in a multidisciplinary, matrix team environment required
- Evidence of strong leadership, influencing, negotiation, and management skills