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
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
Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Medical
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Pfizer Chennai, Tamil Nadu, IND Office
Chennai, India
