Information Management - Treatment and Regimen Information Manager

ROLE SUMMARY

The individual filling this position will be part of a team providing centralized randomization and blinding services to cross-functional business process operations executing clinical study conduct. Individuals filling the this position are responsible for leading and executing the business processes required for systematic capture of protocol treatment design, as part of overall randomization response efforts.  The incumbent will execute and support study-level business processes for randomization schedule generation, validation, blind maintenance, critical response and inspection readiness.

ROLE RESPONSIBILITIES

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

• Manage business processes required for systematic capture and maintenance of study level treatment and regimen design in support of cross-functional break blind and dose calculation procedures. 
• Review protocol and assess systematic design requirements.  Execute design capture per business process, service level agreement, and SOP mandates.
• Collaborate across functional lines to ensure effective design interpretation, quality and compliance with integrating systems and procedures. 
• Act as Subject Matter Expert to advise and troubleshoot integrating procedures. 
• Monitor for requests and coordinate support with fellow team members.
• Monitor for and 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.
• Coordinate and provide critical response solution and support for prioritized treatment and randomization task work, meeting timelines and key milestone deliveries in multiple time zones.
• Assess request, acting as gatekeeper executing all directives while maintaining the confidentiality of sensitive blinded data
• Escalate randomization system technical concerns as they occur, and track response for study team stakeholders
• Maintain accurate metrics according to organizational objectives.
• Create and maintain business process documentation and provide colleague mentoring. 
• Lead and support Regulatory inspection, audit preparation and response.
• Maintain accurate and secure records supporting all study-related treatment and randomization tasks, documentation, and correspondences
• Maintain TMF documentation and file processes according to Pfizer SOPs and policies. 
• Leverage business expertise to support system development,  requirements gathering, UAT and validation, where required

BASIC QUALIFICATIONS

• Training or equivalent experience in current Information Management concepts and practices.

• Knowledge of treatment data capture systems and electronic break blind procedures
• Knowledge of clinical protocol design and treatment schedule interpretation
• Knowledge of randomization system procedures in the healthcare and/or pharmaceutical industry
• 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, including an understanding of the drug development process.
• Knowledge of protocol development and ability to read treatment schedule within protocol
• Knowledge of Healthcare and/or Pharmaceutical metadata and standards
• 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 Interactive Response Technology systems
• Experience with query tools/data extraction techniques (e.g. SQL, PL/SQL, etc.)

Training & Education:

• Bachelor's degree and 7 years experience in the pharmaceutical research and development industry
• Clinical data expertise required
• Treatment data blinding and break blind experience required, expertise preferred
• Randomization generation experience required, expertise preferred
• Proficiency in handling sensitive data
• Proficiency of electronic file systems and maintenance
• Knowledge of secure file transfer protocols and processes

BASIC QUALIFICATIONS

• Training or equivalent experience in current Information Management concepts and practices.

• Knowledge of treatment data capture systems and electronic break blind procedures
• Knowledge of clinical protocol design and treatment schedule interpretation
• Knowledge of randomization system procedures in the healthcare and/or pharmaceutical industry
• 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, including an understanding of the drug development process.
• Knowledge of Healthcare and/or Pharmaceutical metadata and standards
• 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, Brio, MS Access)

Training & Education:

• Bachelor's degree and 7 years equivalent experience in the pharmaceutical research and development industry
• Clinical data expertise required
• Treatment data blinding and break blind experience required, expertise preferred
• Randomization generation experience required, expertise preferred
• Proficiency in handling sensitive data
• Proficiency of electronic file systems and maintenance
• Knowledge of secure file transfer protocols and processes

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
• Ability to work occasional non-standard business hours as required by organizational priorities and objectives

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

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

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 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

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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