Study Operations Manager
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Job Location:
Monthly Salary:
Posted on:
3 days ago
Vacancies:
1 Vacancy
Job Summary
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
Purpose
Breakthroughs that change patients lives... At Pfizer we are a patient centric company guided by our four values: courage joy equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Flexibility
We aim to create a trusting flexible workplace culture which encourages employees to achieve work life harmony attracts talent and enables everyone to be their best working self. Lets start the conversation!
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer Pfizer iscommitted to celebratingthisin all itsforms allowing for us to be as diverse as the patients and communities we serve. Together we continue to build a culture that encourages supports and empowers our employees.
Disability Inclusion
Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!
Required Experience:
Manager
Key Skills
About Company
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