Information Management - Randomization Senior Associate
The individual filling the position listed will partner with study teams and task team to execute critical business processes for all randomization generation, validation, blind maintenance, document management and critical response activities. The individual will provide first line response and communication to line leadership. The incumbent will respond to critical support requirements, track coverage, collect metrics, and contribute to system development and maintenance.
The major duties and responsibilities will include but are not limited to:
- Execute study level randomization task requests in compliance with all applicable Regulatory requirements, standard operating procedures and business process policies, while maintaining corporate service level agreements.
- Monitor daily incoming tasks and provide Lead Point-of-Contact support for critical randomization task response.
- Assess requests and determine support requirements for prioritized randomization task work, meeting timelines and key milestone deliveries in multiple time zones.
- Communication POC for LT and cross-functional teams, as required for priority studies and tasks as part of critical response.
- Partner with LT to coordinate additional support within team as required for complex or critical tasks.
- Leverage knowledge of business process to mentor randomization colleagues as directed by LT.
- Create and maintain business process documentation.
- Act as gatekeeper and execute all directives while maintaining the confidentiality of sensitive blinded data.
- Provide task level business process and system navigation assistance and mentoring for stakeholders including cross-functional study team members and integrating business line colleagues.
- Escalate randomization system technical concerns as they occur, track response and coordinate communication for study team stakeholders
- Oversee 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.
- Oversee TMF documentation and file processes according to Pfizer SOPs and policies.
- Manage all documentation procedures to ensure Global Regulatory inspection readiness, audit preparation and response.
- Coordinate, and develop as required, metrics collection procedures, maintaining reliable metrics according to organizational objectives.
- Support Regulatory inspection, audit preparation and response.
- 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 clinical trial randomization table generation and maintenance procedures.
- Knowledge of sensitive clinical or blinded data handling in the healthcare and/or pharmaceutical industry
- Knowledge of Global Regulatory and audit procedures
- Knowledge of secure data system procedures in the healthcare and/or pharmaceutical industry
- Knowledge of document management practice and business processes in the healthcare and/or pharmaceutical industry
- Experience with business workflow process systems
- Experience with subject randomization generation systems
- Experience with data and document repositories
- Experience with Electronic Data Capture systems
- Experience with query tools/data extraction techniques (e.g., SQL, PL/SQL, etc.)
Training & Education:
- Bachelor's degree or minimum 5 years of experience in Clinical Trial Randomization or IRT
- Randomization table generation and maintenance experience required - expertise preferred
- Clinical data experience required
- Proficiency in handling sensitive data required
- Proficiency of electronic file systems and maintenance
- Knowledge of secure file transfer protocols and processes
- Proficiency in document management
Additional Required Qualifications:
- Knowledge of Pharmaceutical drug development environment and regulations.
- Demonstrated customer relationship skills and capabilities and collaboration on teams.
- Demonstrated ability to perform in a cross-functional environment.
- 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
- Strong organizational and prioritization skills
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.Sunshine ActPfizer 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 EligibilityPfizer 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.Information & Business Tech#LI-PFE