ROLE SUMMARY

Real World Evidence (RWE) generation is a critical strategy enterprise wide. 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 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 Evidence Generation Operations Team within Worldwide Medical and Safety (WMS) and is primarily responsible for operational planning and project management for Global Medical Epidemiology led studies (e.g., CT-24 GSOP and CT-34 GSOP) to ensure consistency and compliance in process adherence. The Senior Manager will also serve as a SME representative and advocate for the Ops team.

The major duties and responsibilities will include but are not limited to:

Stakeholder Responsibilities

• 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)

Vendor Management

• Provide guidance and assist as needed with vendor selection and contracting (i.e. preferred vendors, operational review of proposals, drafting contracts with procurement)

• Vendor assessment and 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

Study Management

• 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

• Provides consultation on NIS research designs, analysis, and interpretation.

• Support development and implementation of NIS-related GSOP training materials for our stakeholders

• Support development and uptake of new enterprise-wide standards to ensure consistency in evidence generation processes (i.e. CT24 Quality Plan)

• Provide SME support for study managers and study assistants regarding adherence to all relevant and applicable SOPs

• Manage study assistants to successfully deliver on commitments and development goals (2-4 direct reports)

• 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-related GSOPs

• Provide mentoring to help develop junior colleagues

QUALIFICATIONS

• Preferred Masters Level degree (MPH, MS) in a health-related field such as health services research, public health, epidemiology, or health economics and minimum 7 years of relevant clinical trial, non-interventional study and/or epidemiologic study experience.

• Or Bachelor’s Degree and 9 years of relevant clinical trial, non-interventional study and/or epidemiologic study experience.

• Clinical study or NIS 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

• Strong working knowledge of the technical and methodological aspects of registries, post-authorization safety studies, and observational study design and implementation.

• Capable of independently managing complex registry and non-interventional study projects.

• Skilled in functioning within a matrix organization where managing through influence is required

• Excellent interpersonal skills required: ability to understand and respond to multiple internal and external customers

• Ability to influence stakeholders constructively and to minimize conflict

• 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.

 
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
 

PHYSICAL/MENTAL REQUIREMENTS

N/A

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Flexibility to participate in meetings for European and Asian time-zones as needed

OTHER INFORMATION
Work Location Assignment: Flexible

Last Day to Apply: 4/7/2023

The annual base salary for this position ranges from $113,900.00 to $189,700.00. In addition, this position offers an annual bonus with a target of 17.5% of the base salary and eligibility to participate in our share based long term incentive program. Benefits offered include a retirement savings plan, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans. Salary range does not apply to the Tampa, FL location.

Relocation assistance may be available based on business needs and/or eligibility.

Medical

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