Information Management - Randomization Associate
- ogłoszenie wygasło rok temu
- Umowa o pracę
- Praktykant / Stażysta
Individuals filling the position listed are responsible for executing the business processes required for randomization schedule generation and validation, blind maintenance, task monitoring, document management, and regulatory compliance.
Information Management - Randomization AssociateNumer ref.: 134550
- 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 required
- 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 and collaboration on teams.
- 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
- Ability to provide global support and response, which may require working a non-standard business schedule and occasionally provide weekend or holiday coverage as required by organizational priorities and objectives
To apply please visit our website www.pfizercareers.com and search job posting: 4830872