Director, Veeva Clinical CTMS Lead

OVERVIEW:

At Pfizer, technology impacts everything we do. Our digital and ‘data first’ strategy focuses on implementing impactful and innovative technology solutions across all functions, from research to manufacturing. As a Digital - Director Business Analyst, you will play a crucial role in improving patients' lives by digitizing drug discovery and development, identifying solutions, and making our work easier and faster. Your contributions will make a difference to countless lives, fostering a culture that promotes innovation and thrives on doing better for patients and healthcare.

ROLE SUMMARY:

This role will provide leadership and deep subject matter expertise in the drug development processes as well as associated change management and support activities for the Clinical Data & Information Sciences, Clinical Development & Operations system portfolio.  Incumbent will partner with Digital & Technology and functional lines within CDO to ensure timely system(s) data integrity and compliance.

Further, in this role, you will:

• Facilitate the integration of Clinical Data & Information Sciences solutions into business processes

• Collaborate with other leaders to define strategies, best practices, and sustainable solutions that ensure the quality of the content management systems.

• Drive innovation by leading a collaborative program of continuous improvement on scalable solutions within the organization

• Ensures that the company’s critical information and records stored within CD&O–owned repositories are managed in accordance with external regulations and internal processes, are protected and controlled over the long term and that data/content is available for critical business needs and is retained in accordance with established retention schedules.

• Determine strategies and implement infrastructure update improvements to enhance end user experience

• Participate in governance, change management, roadmap and budget planning activities for the portfolio of applications.

• Lead teams of Clinical Data & Information Sciences professionals and liaise with business and technical groups to define or gather business requirements, define new business and support processes or improve existing processes.

• Provides solutions to complex operations issues and communicate these solutions in an influential manner to relevant stakeholders resulting in appropriate decisions. 

• Coordinates participation in system release activities.

• Interface with strategic projects and services vendors to understand and influence projects and platforms direction, usability, features and performance to assist business efficiency and quality.

• Take maximum advantage of new technology by proactively engaging in partner groups to explore new solutions.

• Lead/facilitate development of solution test strategies and user acceptance testing approaches during system releases to ensure high quality WRD systemsServe as a subject matter expert and content interface for regulators plus provide Inspection Readiness consultation POC and provide in-room support during Inspections or Audits

BASIC QUALIFICATIONS:

• Bachelor’s with at least 8 years of experience or MBA/MS with at least 7 years of experience or PhD/JD with at least 5 years of experience or MD/DVM with at least 4 years of experience

• Demonstrated, basic knowledge of healthcare and/or pharmaceutical drug development environment and regulations.

• Understanding of Clinical Trial processes such as study startup, site management, site monitoring, and operational reporting

• 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 interface with international colleagues, understand the “big picture” in terms of potential implications of changes to systems and processes to sites and/or affiliates outside of home country/region

• Strong project management and organizational skills

• Ability to evaluate the quality of underlying data and its potential applications

• Exemplary relationship management skills, coupled with the ability to influence and negotiate outcomes

• Strong analytical, problem-solving, and planning capabilities

• Customer-oriented approach in work and solutions

PREFERRED QUALIFICATIONS:

• Master's degree with relevant pharmaceutical industry experience.

• Experience in leading cross-functional teams and managing large-scale projects