Pfizer Study Manager II in San Diego, California
This is a remote based or on-site role at one of the Pfizer R&D locations listed.
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.
The Study Manager (SM) has responsibility for all study management aspects of assigned studies of limited complexity (e.g. single country, small number of countries) or manage a unique part of a larger study (e.g. recruitment and retention).
The Study Manager leads and manages the tactical execution of one or more clinical studies from study startup through database release
Responsible for Study Management and oversight of all Study Management functions internally and at the CROs
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 Randomisation System with Supply Chain Lead
Reviews consolidated Pre-trail Assessment reports, feasibility outputs, etc.
May support study level submission readinessStudy 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 designSubject Matter Expertise
The Study Manager will be the technical expert for study management systems and processesThe 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.
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 years relevant experiencePrior Experience Preferred:
Demonstrated study management experience
Experience with CRO oversight
Demonstrated experience in managing per subject costs, vendor & ancillary, and monitoring costs projections & spend
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)
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.
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Additional Offer Details:
Additional Location Information : This is a remote based or on-site role at one of the Pfizer R&D locations listed.
Eligible for Employee Referral Bonus
A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.