Pfizer Information Management in Kansas City, Missouri
Individuals filling the position listed are responsible for executing the business processes required for randomization schedule generation and validation, task monitoring, blind maintenance, critical response, and procedural document regulatory compliance.
The major duties and responsibilities will include but are not limited to:
Execute critical randomization functional procedures according to standard operating procedure and business process policy.
Assess requests and determine appropriate application of business process for resolution, in a timely manner consistent with corporate service level agreements.
Monitor for and respond to all activities and requests according to standardized schedule.
Act as gatekeeper, and execute all directives in accordance with organizational prioritization, while maintaining the confidentiality of sensitive blinded data
Provide critical response support for prioritized studies, meeting prioritized timelines and key milestone deliveries.
Provide business process and system navigation support for study team stakeholders.
Escalate randomization system technical concerns as they occur
Coordinate, and develop as required, metrics collection procedures, maintaining reliable metrics according to organizational objectives.
Execute record collection processes, ensure critical records are stored within COE-owned repositories, managed in accordance with external regulation and internal processes, and are protected and controlled over the long term in accordance with established retention schedules.
Execute TMF documentation and file processes according to Pfizer SOPs and policies.
Execute all documentation procedures to ensure Global Regulatory inspection readiness, audit preparation and response.
Create and maintain business process documentation. Mentor fellow colleagues as required.
Leverage knowledge of process and system function to contribute to system requirements development, UAT and validation.
Knowledge of clinical research conduct and drug development lifecycle
Knowledge of Global Regulatory and audit procedures
Knowledge of clinical data systems and procedures
Knowledge of document management business processes, including secure Trial Master File procedures in the healthcare and/or pharmaceutical industry
Knowledge of data quality and validation procedures
Training or equivalent experience in Information Management concepts and practices.
Knowledge of Healthcare and/or Pharmaceutical metadata and standards
Proficiency with secure document management systems
Proficiency with metric capture processes and systems
Proficiency with electronic Trial Master File systems and procedures
Experience with business process management tools and systems
Experience with query tools/data extraction techniques (e.g., SQL, PL/SQL, etc.)
Training & Education:
Bachelor's degree OR 5 years of experience working in the pharmaceutical research and development industry
Document management expertise required
Proficiency of electronic file systems and maintenance required
Pharma Regulatory response and inspection readiness experience required
Clinical data handling and business process experience required
Metrics development and maintenance preferred
Randomization table maintenance experience preferred
Proficiency in handling sensitive data preferred
Additional Required Qualifications:
Basic knowledge of Pharmaceutical drug development environment and regulations.
Demonstrated customer relationship skills and capabilities
Collaborative and capable of productivity in on-site and remote settings.
Strong verbal, written communication and presentation skills.
Ability to interact in a professional manner and build strong collaborative relationships with internal Pfizer teams.
Ability to interface with international colleagues, understand the "big picture" in terms of potential implications of affiliates outside of home country/region
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Ability to work occasional non-standard business hours, weekends or holidays as required by organizational priorities and objectives
Other Job Details:
Eligible for Relocation Package: NO
Eligible for Employee Referral Bonus: YES
Pfizer 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.
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.
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