To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.
Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world.
Global Study Managers provide operational leadership throughout the study lifecycle, with accountability for oversight and execution of study management, site management, 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 the 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 the 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
Accountable for Study Management and oversight of all Study Management functions
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 localInvestigator 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, consistentprocesses, and excellence in Study Management deliverables related to cost-effective, timely, andhigh-qualityclinicaltrialdataaccordingtoagreedglobalgoals.
The Global Study Manager will be responsible for the technical oversight of the operational subteam to include but is not limited to standards, continuous improvement, issueescalation/resolution,inspection readiness/quality assurance, performance feedback, review of metrics.
The Global Study Manager partners with the operational sub teamand pCROto proactivelyidentify and resolve study operations staff performance issues.
For project-specificaudits and inspections, the Global Study Manager can serve as a resource tothe study team in addition to the Study OperationalManager(s), if assigned,to facilitate theaudit/inspection.
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
PREFERRED QUALIFICATIONS
Skills
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
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Travel may be required, including Investigator Meetings, Vendor Kick Off Meetings and Vendor Re-set Meetings. In addition, Study Manager also expected to travel to global-GSSO or department-level meetings.
Global Study Manager may be required to work outside of core business hours to support global trials or initiatives.
We are proud to offer employees a flexible working model that is grounded on empowering colleagues to design their workdays so that they can maximize their productivity, enhance their work-life balance and support a way of working that fosters innovation and patient-centricity. Currently, our employees are expected to be on-site 2.5 - 3 days per week blending on-site collaboration and connection with off-site remote working when it makes business sense to do so.
Work Location Assignment: Remote - Field Based
The annual base salary for this position ranges from $109,400.00 to $182,300.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
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. This position requires permanent work authorization in the United States.
Medical
Breakthroughs that change patients’ lives
Research confirms what intuition tells us: that purpose-driven companies perform better, are more innovative, attract and retain the best people, and know how to unleash the power of those people. Pfizer’s purpose—Breakthroughs that change patients' lives—fuels everything we do and reflects our passion for building on our legacy as one of the greatest contributors of good to the world.
Each word in our purpose has meaning and reflects the value we strive to bring to patients and society:
“Breakthroughs” - These are the innovations, scientific and commercial, that we seek to deliver every day. All colleagues, regardless of role, level or location, strive for breakthroughs every day.
“Change” - We want to do more than simply improve patients’ medical conditions; we want to dramatically change their lives for the better.
“Patients’ lives” - We consider not only patients, but everyone they touch—including their families, caregivers, and friends—and everything they love to do. It’s an intentionally holistic view.
Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.
Every decision we make and every action we take is done with the patient in mind—and to nurture an environment where breakthroughs can thrive.
Our Values
To fully realize Pfizer’s purpose, we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.
The “how” is represented by four simple, powerful values—courage, excellence, equity, and joy—that define our company and our culture.
Courage: Breakthroughs start by challenging convention, especially in the face of uncertainty or adversity. This happens when we think big, speak up, and are decisive.
Excellence: We can only change patients’ lives when we perform at our best together. This happens when we focus on what matters, agree who does what, and measure our outcomes.
Equity: We believe that every person deserves to be seen, heard, and cared for. This happens when we are inclusive, act with integrity, and reduce healthcare disparities.
Joy: We give ourselves to our work, but it also gives to us. We find joy when we take pride, recognize one another, and have fun.
Pfizer Research & Development
Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world.
With an unwavering commitment to innovation, we use a multidisciplinary approach that blends scientific expertise, cutting-edge technologies, and strategic collaborations, igniting a powerful engine that propels groundbreaking discoveries into life-saving treatments for patients in need.
Through our relentless pursuit of progress, we envision a future where cutting-edge medicines pave the way to healthier, happier lives worldwide.
Benefits at Pfizer
Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues. Our Pay for Performance Philosophy and Practices reward colleagues based on the contributions they make to our business.
Our Competitive Benefits Programs help our colleagues by:
Promoting Health and Wellness to help colleagues maintain and improve their physical and mental wellbeing. Pfizer offerings include health and disability insurance, preventative health programs, medical screenings, free or reduced-cost vaccinations, discounts on Pfizer products, mental health support, nutrition and fitness counseling and more.
Strengthening Colleagues’ Financial Security by providing company contributions to retirement plans, life insurance and financial planning education to help colleagues achieve their financial goals.
Providing Benefits and Time off for the Moments that Matter to ensure Pfizer colleagues have the time away from the office to recharge, recover and return to work as the best version of themselves. Vacation, Holiday time and Sick time are just the beginning, with a 12 week parental leave policy for both parents of a new born, 10 day of caregiver leave for those times when your family needs you whether it’s a child, spouse or parent, bereavement leave, and additional country-specific programs.
And so much more, depending on your country and site, Pfizer offers childcare facilities or discount programs, on-site health and/or fitness centers, movement and mindfulness solutions, “Log in for your Day” work flexibility and so much more.