- Responsible for the creation, development and maintenance of EDCMS clinical database including all data capture requirements and systems to ensure compliance for protocol execution, increased system productivity and data quality.
- Provides end-to-end clinical systems, regulations, standards, quality and database expertise to PCRU staff and clinical study teams on clinical from data collection through reporting
- Applies appropriate regulatory and ICH compliance by providing appropriate risk assessment and mitigation as it relates to PCRU systems and related procedures and processes.
- Executes and implements strategic decisions for PCRU operations related to clinical data integrity and subject/patient safety. Executes the creation of metadata and collection tools in accordance with CDISC and appropriate Pfizer standards (i.e. assessment windows, questionnaires, global and local collection drop down windows, automated data processes)
- Provides in depth PCRU and clinical database expertise to the clinical study teams to ensure protocol defined design, data capture and downstream reporting is correct, complete and consistent in terms of data quality and expected output. Assist as appropriate with query resolution
- Maintains in depth knowledge to evaluate and make decisions on data collection and reporting capabilities based on the SAP (Statistical Analysis Plan), LOT (List of Tables) and Pfizer Data Standards/CDISC to achieve the desired reporting outcome for transfer of data downstream reporting systems and a complete, correct, and consistent Clinical Study Report
- Contributes as appropriate to overall training programs related to EDCMS and collaborate with internal groups (pharmacy, medical, clinic coordinator, project management and laboratory) to ensure a consistent approach with minimal overlap with targeted business process specific training.
- Provides expertise in systems usage, clinical data collection processes and related PCRU SOP's. Working with various PCRU groups, such as SUG, GET Quality, and the LT, provides impact assessments of new procedures and process on systems, and provides impact assessments of new systems on processes and procedures.
- Partners with the PCRU specific Laboratory Information Management System (e.g. LIMS, GLIMS) administrator to ensure consistency of data collection and quality connection interfaces between the systems are producing expected quality output to all downstream review tools and reporting systems.
- Participates in recommendations to the PCRU Global Clinical Systems Team on how systems will be used and impact the local business in the PCRU by owning the evaluation, development and maintenance of system installations, configuration, procedures and processes.
- May help to evaluate emerging and existing technologies and makes recommendations on best practices to enhance processes to support local business requirements. May provide local strategic thought within the PCRU to drive innovative and optimal solutions. Participates in the exploration, coordination and implementation of emerging technologies/techniques.
- May participates in developing and performing UAT (User Acceptance Testing) as required.
- Other responsibilities
- Collaborates with and evaluates needs of internal CRU (MD's, pharmacy, lab, clinic floor activities) and external departments (clinical, stats, CRDC, CAG) to understand their analytic objectives, business needs and to provide the necessary services from a data and systems perspective
- Manages multiple complex protocols at one time, independently, all in different stages from development to active execution in the clinic to reporting as well as inquiries on past reported studies conducted at the CRU
- Serves as a SME (Subject Matter Expert) to solve highly complex system matters. Coordinate and direct solutions to connect the CRU clinic workers to the requirements and workflow of clinical study team members and related downstream reporting systems
- Ensures all clinical data flow is regulatory/ ICH-GCP compliant.
- May represents the PCRU at SUG (Systems User Group) and EDCMS SOP global meetings
- May interfaces locally with the regulatory agencies around data warehousing projects and other clinical data related projects
- Bachelor's degree or equivalent training/experience, with drug development and business experience in order to have a thorough understanding of the processes associated with clinical, regulatory and marketing operations.
- Project management, administrative and technical capabilities are required.
- BS in scientific, health profession, or computer field preferred.
- International experience preferred.
- At least 3 years of relevant pharmaceutical industry experience in automation, system design, testing, and validation; previous experience in a GxP environment.
- Comfortable working in a disciplined systems programming environment; experienced with a Software Development Life Cycle (SDLC) and regulatory validation requirements
- including 21 CFR Part 11
- Direct experience in early clinical development including clinical data collection, handling, and analysis and reporting preferred.
- Able to manage multiple projects simultaneously
- Good interpersonal, verbal and written communication skills are essential. Demonstrated ability to work collaboratively in multidisciplinary teams
- Demonstrated knowledge/understanding of technologies to support data acquisition, workflow automation, analysis and reporting; strong understanding of state-of-the-art technologies and how to leverage them into improved into improved business processes for worldwide deployment and adoption.
- Ability to clearly and accurately present ideas to relevant audiences and to elicit consensus or facilitate decision-making.
#LI-PFEPfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.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
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