Study Manager - FSP

The SM 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 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. 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 and monitoring plans and for delivery to the agreed plans.
The Study Manager is a core member of the Study Team and will represent the CRO 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.
Organizational Relationships

• Responsible for liaising with members of the project team to include but not limited to: Clinical

Study Team Lead (CSTL), SCC, Lead Data Manager (LDM), Lead CPW, Clinician, C&O, U.S.
region and Pfizer Country Office (PCO) CPMs.

• Will also liaise with Clinical Study Team Lead (CSTL), Asset Lead or Clin Ops Study Team Lead

for technical system and process expertise and TA operational knowledge.
Primary Duties
Operational Study Management for 1 or more studies of limited complexity (e.g. Pfizer Clinical
Research Unit, single country, small number of 3rd party vendors) or manage a unique part of a
larger study (e.g. recruitment and retention, 3rd party vendors):

• Accountable for the development of realistic detailed study startup and monitoring plans
• Accountable for conducting country level feasibility in collaboration with Global Clinical Trial

Execution and CROs, reviewing Pre-trial Assessment outputs, approving sites, and assessing site
activation plans

• Leads study risk planning process in context of site and subject
• Coordinates study/protocol training & supports investigator meetings
• Develops and provides key inputs to Clinical Trial Budget (e.g., Per Subject Costs)
• Accountable for the delivery of the study or subset of agreed study activities against approved plans
• Leads inspection readiness activities related to study management and site 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.)
Study Management Oversight:

• Approves the Study Startup, Study Monitoring & protocol recruitment plans
• Approves & oversees drug supply management – manages flow of drug supply to the sites & set

up Interactive Voice Randomization System with Supply Chain Lead

• Reviews consolidated Pre-trail Assessment reports, feasibility outputs, etc.
• May support study level submission readiness

Study Team Interface:

• Leads and oversees some or 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 to determine 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 Project Manager (and study team)
• May provide ongoing assessment of subject enrollment / discontinuations to inform accurate

forecasting for financial planning

• May provides operational input into protocol design

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: mentoring, 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 can serve as a resource to the study

team to facilitate the audit/inspection.
Qualifications
Training and Education Preferred:

• Clinical trial/study management experience
• Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations
• BS / Nurse – minimum of 2 years’ relevant experience
• MS/PhD – minimum of 1 year of relevant experience

Prior Experience Preferred:

• Demonstrated study management experience
• Experience with CRO oversight
• Demonstrated experience in managing per subject costs, vendor & ancillary, and monitoring costs

projections & spend
Skills:

• Understands how to work with vendors to accomplish tasks
• Ability to interpret study level data & translate and identify risks
• Ability to proactively identify & mitigate risks around site level in study execution
• Understands feasibility of protocol implementation
• Country level cultural awareness and strong interpersonal skills
• Keen problem-solving skills
• Excellent communication skills, both written and verbal. Must be fluent in English.
• Detail oriented & possesses technical expertise (e.g., spreadsheets, metrics & data flow

management)