Study Operations Manager

Pfizer

Why Patients Need You 

Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary expertise or investigating how to close gaps in data, our mission is simple. Empower healthcare decisions regarding the safe and appropriate use of medicines for patients. 

What You Will Achieve 

You will be part of Pfizer's medical team and manage the clinical studies. Your project management skills will be leveraged for planning, directing, creating and communicating timelines. You will ensure that the clinical studies are within time, budget and scope. 

As a Manager, you provide guidance to operational teams for managing projects. Your planning skills will help in preparing forecasts for resource requirements, and providing areas of improvement for products, processes or services. Through your comprehensive knowledge of principles, concepts and theories of the discipline, you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate agreements between different teams. 

It is your problem solving ability and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe. 

Responsibilities:

This position will be housed in the newly formed Evidence Generation Platform, which 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 two 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 GAV, strengthen the value evidence package for payers and access/policy decision-makers;
  • Support measurement of short- and long-term impact of Pfizer’s products to both patients and populations;
  • Support competitive differentiation.

The Evidence Generation (EvGen) Study Operations Manager (SOM) will provide operational support for the Evidence Generation 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, Global Access and Value and others to support the execution of evidence generation per a product integrated evidence plan.

The EvGen SOM will be responsible for coordinating study operational activities and deliverables for all assigned projects and ensuring compliance with applicable SOPs.

The SOM 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 SOM will liaise with members of the extended Evidence Generation Platform team, especially the Clinical Scientist as well as with other Pfizer partners.

Qualifications:

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

Minimum of 5 years of relevant (prior clinical trial, 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.

Work Location Assignment: Flexible

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. 

Pfizer colleagues in different countries work together to improve the health of people all over the world. We are constantly working on the development of innovative therapies and growth opportunities, being in continuous search of new talents. 

Flexible Work Environment 

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. Let’s 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 is committed to celebrating this, in all its forms – 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. 

Medical

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Confirmed 8 hours ago. Posted 10 days ago.

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