Director, Veeva Clinical CTMS Lead
About The Position
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
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
- Permanent work authorization in the United States.
Nice To Haves
- Master's degree with relevant pharmaceutical industry experience.
- Experience in leading cross-functional teams and managing large-scale projects
- Advanced knowledge of Veeva Clinical or other Clinical Trial Management Systems (CTMS)
- Strong understanding of regulatory requirements and compliance in the pharmaceutical industry
- Proven track record of driving digital transformation initiatives
- Ability to work in a fast-paced, dynamic environment and manage multiple priorities
- Strong leadership and team management skills
- Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance
- Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
Responsibilities
- 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 systems
- Serve 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
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 to include medical, prescription drug, dental and vision coverage.
- Relocation assistance may be available based on business needs and/or eligibility.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Director
