Study Operations Manager

This role has a fixed term period of 1 year.

Use Your Power for Purpose

Reporting to the Research & Development division, you will be integral in bridging evidence-based medical decision support with colleagues and stakeholders to enhance health and treatment outcomes. By developing frameworks to ensure our evidence is scientifically robust, providing unbiased and medically necessary expertise, or investigating data gaps, our mission remains clear: to empower healthcare decisions regarding the safe and appropriate use of medicines for patients. Your work will support better health outcomes, ensuring that our evidence is sound and that healthcare decisions are informed and safe for patients.

What You Will Achieve

1.           STUDY IMPLEMENTATION & MANAGEMENT

• Support via execution of operational tasks the conduct of studies and projects (Non-Interventional Studies, Low Interventional Studies, etc.) 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)   

• Maintain study details in required systems as necessary from concept to close-out (CTMS, SToD, etc)

• Support audits/inspections as applicable

2. DEPARTMENT LEVEL SUPPORT

• Assist with entry of study details into any of a variety of systems on behalf of department colleagues

• Work with Clinical Scientist team and other operational colleagues on department-wide financial updates and information collection/reporting

Here Is What You Need (Minimum Requirements)

• BA/BS Degree in science, health-related field or epidemiology with at least 5 years of relevant (prior clinical trial, non-interventional study and/or epidemiologic study) experience.

• 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

  
Work Location Assignment: Hybrid

Medical