Director – Veeva Clinical CTMS Lead

Role Overview

• Provide leadership and deep subject matter expertise in the drug development processes
• 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
• Ensure that the company’s critical information and records stored within CD&O–owned repositories are managed in accordance with external regulations and internal processes
• 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
• Provides solutions to complex operations issues and communicate these solutions in an influential manner to relevant stakeholders
• Coordinates participation in system release activities
• 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 during system releases to ensure high quality WRD systems
• Serve as a subject matter expert and content interface for regulators plus provide Inspection Readiness consultation POC and support during Inspections or Audits

Requirements

• 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

Benefits

• 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
• Paid vacation, holiday and personal days
• Paid caregiver/parental and medical leave
• Health benefits including medical, prescription drug, dental and vision coverage