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Pfizer
Why Patients Need You
Pfizer’s purpose is to deliver breakthroughs that change patients’ lives. Research and Development is at the heart of fulfilling Pfizer’s purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world.
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
It is our mission to strengthen the oversight of our clinical data through stronger ownership, control, and visibility of our clinical data. You will play an important role in processing, reviewing, and receiving patient data and records. You will be organizing clinical data forms from therapeutic groups and outside investigators. You will ensure that accurate, timely, and consistent clinical data reaches the medical department and other groups. You will be relied on for data management plans including data preparation, data validation activities, etc.
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 dedication and focus that will help make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
Provide guidance, lead/co-lead projects, manage own time to meet objectives, plan resource requirements for projects across the division.
Ensure work carried out by providers is in accordance with applicable Standard Operating Procedures (SOPs) and working practices.
Promote the use of consistent, efficient, and quality processes to meet timelines and deliverables.
Serve as Clinical Data Scientist and Trial Lead for one or more clinical trials assuming responsibility for all Data Monitoring and Management (DMM) activities and interact with Clinical Data Scientist at study level for deliverables.
Serve as a technical resource to the study teams for data visualization and reporting tools and provide technical expertise and business process support in technology systems.
Ensure operational excellence in collaboration with partners for application of standards, data acquisition, proactive data review and data integrity and overall data management activities.
Partner with Research/Business Units and any external DM service provider to deliver high quality data management for all studies as assigned.
Perform central monitoring activities including review system outputs, propose suggestions for signal and action management, and follow up with study team for the action resolutions.
Plan and execute communication plans and methods for engaging customer populations.
Qualifications
Must-Have
Bachelor's Degree
5+ years’ experience
Experience within the pharmaceutical industry or in a health information management role
Working knowledge of all phases of clinical trials and ability to assess and determine study requirement from protocol review
Working knowledge of clinical research, Food and Drug Administration & International Conference on Harmonization Good Clinical Practices (GCDMP), and related regulatory requirements
Strong Project and Risk Management
Strong verbal and written communication skills, demonstrated ability to handle multiple tasks and projects
Knowledge of Windows Environment and its applications.
Nice-to-Have
Master's degree
Contract Research Organization {CRO} and vendor oversight experience
Proficient in using commercial clinical data management systems and/or EDC products
PHYSICAL/MENTAL REQUIREMENTS
No specific requirements
Work Location Assignment: Remote
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
