Information Management

2 weeks ago

Sandwich, United Kingdom Pfizer Full time

Job Description: Information Management - Randomization Associate

ROLE SUMMARY

Individuals filling the position listed are accountable for executing the business processes required for randomization schedule generation and validation, task monitoring, blind maintenance, critical response, and procedural document regulatory compliance.

ROLE

The major duties and responsibilities will include and are not limited to:

- Execute critical randomization functional procedures according to standard operating procedure and business process policy.
- Monitor for and reply 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.

BASIC QUALIFICATIONS
- Knowledge of
- clinical research conduct and drug development lifecycle
- Global Regulatory and audit procedures
- clinical data systems and procedures
- document management business processes, including secure Trial Master File procedures in the healthcare and/or pharmaceutical industry
- data quality and validation procedures
- Healthcare and/or Pharmaceutical metadata and standards
- Training or equivalent experience in Information Management concepts and practices.
- Proficiency with
- secure document management systems
- metric capture processes and systems
- electronic Trial Master File systems and procedures
- Experience with
- business process management tools and systems
- query tools/data extraction techniques (e.g., SQL, PL/SQL, etc.)

Training & Education:

- Bachelor's degree OR extensive knowledge of working in the pharmaceutical research and development industry through in-role experience
- REQUIRED:

- Document management expertise
- Proficiency of electronic file systems and maintenance
- Pharma Regulatory response and inspection readiness experience
- Clinical data handling and business process experience
- PREFERRED:

- Metrics development and maintenance
- Randomization table maintenance experience
- Proficiency in handling sensitive data

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 teams.
- Ability to interface with international colleagues, comprehend the “big picture” in terms of potential implications of affiliates outside of home country/region

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Able to work occasional non-standard business hours, weekends or holidays as required by organizational priorities and objectives.

Work Location Assignment: On Premise (Sandwich, Kent, UK) with flexibility

Alternative locations: Shanghai, China

Purpose

Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.

Digital Transformation Strategy

One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Flexibility

We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation

Equal Employment Opportunity

We bel

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