The Study Operations Manager is responsible for study and regional/country level activities from study startup through conduct and study close. The Study Operations Manager will be assigned one or more studies and will be tasked with taking on several responsibilities in support of the larger Study Management deliverables. The Study Operations Manager partners with the Global Study Manager, Study Start Up Project Manager, Site Intelligence Lead, Country Trial Manager, Site Excellence Partners, Site Relationship Partners, Site Care Partners, Contracts Lead, Regulatory Affairs, pCRO and others as required to ensure a coordinated approach to study start up, execution and close out.
The Study Operations Manager has exceptional knowledge in managing and coordinating specific tasks and responsibilities as part of the larger Study Management team. The Study Operations Manager provides leadership and strategic planning and organization skills to ensure the operational delivery of tasks within one or more studies, in accordance with the appropriate quality standards including ICH/GCP standards, SOPs, local operating guidelines and local regulatory requirements, as applicable. The Study Operations Manager may be responsible to independently take on the closing out of one or more studies post database lock. Provides back up to or takes on the responsibilities of Global Study Manager as needed.
Accountable for the execution of tasks and developing solutions to problems as needed to support deliverables. The Study Operations Manager will be fully accountable and responsible for tasks as designated on the study by the Global Study Manager which may include:
Training and Education
Skills and Technical Competencies
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Travel may be required, including Investigator Meetings, Vendor Kick Off Meetings and Vendor Re-set Meetings. In addition, may also expected to travel to global-GSSO or department-level meetings.
May be required to work outside of core business hours to support global trials or initiatives.
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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.
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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.
We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here!
Pfizer is a leading research-based biopharmaceutical company. We apply science and our global resources to deliver innovative therapies that extend and significantly improve lives. We make medicines and vaccines that help people when they are sick and prevent them from getting sick in the first place. Every day, our colleagues work in developed and emerging markets to ...