Position Summary: This position will be housed in the newly formed Real-World Evidence (RWE) platform and specifically within the Clinical Affairs and Operations pillar within that platform. The RWE Platform is responsible for establishing scientific global leadership and stature through the generation of integrated, end-to-end observational real-world evidence serving all therapeutic areas. The platform combines formerly disparate Pfizer functions to:

• Enhance Pfizer’s ability to determine unmet medical needs;
• Support current Product Development programs including finding alternatives and accelerated licensure pathways for new indications through the use of Real-World Data (RWD), Real-World Insights (RWI, and Real-World Evidence (RWE)
• Inform clinical practice on appropriate prescription and use of Pfizer’s products;
• In collaboration with Global Access and Value (GAV), strengthen the value evidence package for payers and access/policy decision makers;
• Support measurement of short-and log-term impact of Pfizer’s products to both patients and populations
• Support competitive differentiation

The RWE Senior Study Operations Manager (SrSOM) will provide operational support for the RWE Platform, including multiple global and local observational clinical and epidemiologic studies within assigned programs. Studies may include Research Collaborations, non-interventional studies, and low-interventional studies. This individual will be responsible for providing operational support to the project while working collaboratively in a Study Team with the Clinical Scientists, RWE Scientists, Medical Lead and Scientific Affairs Leads, GAV teams and others to support the execution of evidence generation per a product integrated evidence plan. The RWE SrSOM will be responsible for coordinating study operational activities and deliverables for all assigned projects and ensuring compliance with applicable SOPs. The SrSOM will be responsible for the baseline operational support including activities such as maintaining accurate updates in all systems, updating timelines, assisting with drafting study operational documents as needed, helping teams navigate operational requirements for each major SOP (NIS, LIS, Research Collaboration), interaction with CRC Managers, scheduling and minuting team meetings, shipping materials, facilitating CDA, Contracts and other contractual documents, archiving of information, status reports, assist with study deliverables such as a CSR or publication and any other operational task the Study Team requires. The SrSOM will liaise with members of the extended RWE Platform team, especially the Clinical Scientist as well as with other Pfizer partners. The SrSOM will also be responsible for managing several members of the Study Operations Manager (SOM) and/or Study Operations Associate (SOA) team as direct supervisor. As a SrSOM, there will also be involvement in and responsibility for completion of initiatives to advance the team, department, pillar, and platform objectives. These initiatives may originate from the SrSOM’s own evaluation of the team needs and areas for improvement or be driven by goals or objectives as initiated by other leaders in the pillar or platform.

POSITION RESPONSIBILITIES:

1. STUDY IMPLEMENTATION & MANAGEMENT

• Support via execution of operational tasks the conduct of studies and projects (Non-Interventional Studies, Low Interventional Studies, Research Collaborations, etc.) across the RWE Platform by working collaboratively with all involved departments and groups
• Coordinate and execute operational responsibilities for assigned studies in compliance with Pfizer policies and procedures
• Schedule, participate in and take minutes during scheduled team meetings (if required) – distribute minutes, action items, follow-up for completion as needed
• Create or assist with study documents as requested by Clinical Scientist or Study Team (MS Word, Excel, PowerPoint)
• Create folders and file documents in shared drive locations (SharePoint, Teams, etc.) for Study Team to actively manage the project
• Prepare and assist others with required internal study documents including, but not limited to, concept submission, due diligence checklist, laboratory worksheets, supply requests, study team rosters, vendor lists, etc.
• May act as primary contact for vendors, including laboratory and/or Clinical Research Organizations and maintenance of associated documentation (i.e., vendor management plans)
• Liaise with external vendors to ensure laboratory supplies and sample shipment arrangements are made in accordance with protocol requirements and follow-up with vendor to ensure supply fulfillment is completed as expected
• Prepare study/project timelines and track progress against stated milestones and deliverables
• Track Pfizer SOP process steps from concept development through study close-out and ensure Study Team is completing all required items per the relevant SOP and or Medical Affairs processes
• Liaise with external collaborators, key opinion leaders, to obtain relevant required documentation need in support of various research activities
• Manage financial aspects of research projects including, but not limited to, tracking invoicing and payment activities, and alignment with departmental budget forecasts, facilitate execution of Confidentiality Disclosure agreements, study contract and updates
• Maintain study master file and file study documents in the appropriate Pfizer repository (i.e. GDMS, PTMF, etc)
• Maintain study details in required systems as necessary from concept to close-out (Siebel, SToD, etc)
• Support audits/inspections as applicable

2. TEAM LEVEL RESPONSIBILITIES

• Identify and drive team initiatives to further grow and develop the SOM team and improve the team’s operating processes
• Act as an internal team SME on the applicable study SOPs as conducted by the SOM team and be responsible for the creation/revision and implementation of guidance materials and tools for the group
• Managing several members (1-5) of the Study Operations Manager and/or Study Operations Associate team as direct supervisor
• Reviews work, develops staff, ensures appropriate succession planning, and provides ongoing feedback.
• Responsible for short- and long-term resource planning, priority setting, and filling of resource and skill gaps to address the needs of the pillar/platform

ORGANIZATIONAL RELATIONSHIPS

Internal interactions: Real World Evidence Platform groups, Clinical Affairs Lead, Medical and Scientific Affairs Leads, Global Health Value and Outcomes, Regional Medical Leads, Pfizer Research & Development (PRD), Regulatory Affairs, Safety & Risk Management, Business Process Owners, Clinical Research Collaboration Project Managers, Outsourcing & Contracting, Accounts Payable, etc.

External interactions: Study Collaborators / Investigators, Key Opinion Leaders, Vendor Personnel, Site Personnel

EDUCATION AND EXPERIENCE

-BA/BS Degree in science, health-related field or epidemiology, or relevant experience is required

-Minimum of 5 years of relevant (prior non-interventional study and/or epidemiologic study) experience is required;

-Experience with participating in and supporting a multidisciplinary team

-Experience in project management - managing fully-outsourced projects or vendor oversight is highly desired for this position

-Exercises own judgement leveraging knowledge and experience. Works independently with instruction on complex problems.

-Fluent in English with exceptional written and oral communication and cross-functional collaborative skills

-Outstanding organizational skills, managing several projects concurrently that are often time pressured; strong ability to effectively multi-task and prioritize

-Proficiency in MS Word, Excel, and PowerPoint

 
 

Medical