Real World Evidence (RWE) generation is a critical strategy for Medical Affairs enterprise wide. Medical Affairs led HEOR Non-Interventional Study (NIS) and Low Interventional Study (LIS) RWD collection, evidence generation and outcomes & analytics are key to filling unmet data needs and informing medical strategy. The Medical Evidence Generation Study Managers lead the tactical execution of one or more NIS/LIS studies for the lifecycle of the project (i.e. study start-up to study close), ensuring inspection readiness and timely delivery of quality study data. The role is part of the Medical Affairs Evidence Generation Operations Team within Worldwide Medical and Safety (WMS) and is responsible for operational planning and project management for Medical Affairs led studies (e.g., CT-24 GSOP and CT-45 GSOP) to ensure consistency and compliance in process adherence. The Study Manager is a core member of the Study Team and will serve as the liaison for study leads, functional lines, and vendors to ensure timely and compliant execution of plans to achieve study objectives.
The major duties and responsibilities will include but are not limited to:
- Ensure studies are conducted in compliance with relevant SOPs and applicable internal, external, regulatory requirements
- Ensure study team and stakeholders are informed of progress against goals, major study risks/opportunities and agree to corresponding contingency/mitigation plans as needed
- Manage information & communications management, providing high quality study information to support decision making, including updates/presentations to senior leadership as requested
- Support audit/inspection readiness preparation and coordination (including relevant QC activities)
Study Level Responsibilities
Internal Study Guidance
- Guide the selection of the appropriate study implementation pathway and ensure adherence to applicable requirements (i.e. SOPs, study type, safety reporting)
- Participate in study design as it relates to the operational implementation of the protocols
- Assist in study team coordination, providing guidance on cross-functional line membership needs (i.e. statistics, data management/programming, medical writing)
- Provide guidance and assist as needed with vendor selection (i.e. preferred vendors, operational review of proposals)
- Vendor oversight for compliance under applicable SOPs, including qualification, confidentiality agreements, and contract review and execution (i.e. CP102, QMS09 GSOP)
- Provide quality oversight of vendor conduct and deliverables per required SOPs
- Coordinate processes for data and/or sample transfers from vendor as needed
- Track delivery of data/work products according to plans, applying Pfizer standards as appropriate to ensure integrity of study data
- Coordinate and prepare deliverables for internal review processes, quality control assessments, and essential document archiving; deliverables may include vendor risk management plans, data collection tools, protocol, statistical analysis plan, interim/final report
- Proactively manage changes and/or variance in scope, budget, expected milestones/deliverables
- Demonstrate Leader Behaviors in problem solving or escalating issues as needed and motivating the study team
Optimize Operations Team Efficiency & Outreach
- Help manage team resources and effectiveness by providing input into toolkits, sharing best practices, troubleshooting issues, and maintaining master study tracker
- Active participation in internal process improvement initiatives
- Reinforce study training materials for relevant NIS/LIS GSOPs
- Provide mentoring to help develop junior colleagues
- Preferred Masters Level degree (MPH, MS) in a health-related field such as health services research, public health, epidemiology, or health economics and minimum 3 years of relevant clinical trial, non-interventional study and/or epidemiologic study experience.
- Or Bachelor's Degree (health-related field as above or research-oriented field like life sciences or social sciences) and minimum 5 years of relevant clinical trial, non-interventional study and/or epidemiologic study experience.
- Clinical study or HEOR experience within the pharma industry is preferred
- Effective collaboration on virtual teams and proactive in optimizing ways of working.
- Flexibility to engage global team members and stakeholders in disparate time-zones
- Capable of independently managing non-interventional study projects; Strong working knowledge of the technical and methodological aspects of registries and observational study design and implementation.
- Ability to influence stakeholders constructively and to minimize conflict while functioning within a matrix organization
- Excellent interpersonal skills required: ability to understand and respond to multiple internal and external customers
- Strong project management abilities (contracting, budgeting, vendor management) essential.
- Demonstrated ability to manage multiple projects (multitask) involving complex processes, significant budget, competing deadlines and rapidly shifting priorities.
- Change oriented, comfortable responding to unexpected demands with tight timelines, team player.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Flexibility to participate in meetings during non-standard work hours as needed
Work Location Assignment:Flexible
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.