Job Summary:
Pfizer Research and Development (PRD) supports clinical development across Pfizer and late-stage development of medicines. Every year, PRD partners with thousands of global participants, health systems and HCPs in our work to bring new medicines to market for the patients that we serve.
This role is responsible for providing subject matter expertise in the management of the Clinical Development & Operations (CD&O) applications as well as project management, change management and operational management of the applications in the Clinical Data and Information Sciences (CDIS) portfolio.
As part of an agile team, this role will lead the ideation, strategy, and development of information sciences solutions; use business analysis skills and domain knowledge to elicit requirements and drive timely decisions to achieve desired business outcomes; and work across applicable business lines and support organizations to execute projects that deliver robust solutions.
This role will partner with Pfizer Research and Development, Digital and other support functions to ensure timely project execution and delivery.
The team is seeking candidates that have a proven track record of performing analytical activities but also possess a passion for developing creative solutions to meet changing clinical trial needs.
Job Responsibilities
Work closely with functional lines to articulate business needs for new solutions or changes to existing solutions and document business requirements for assigned solutions. Run workshops and conduct interviews with functional line SMEs to understand the business need and then ensure full and complete requirements set. Ensure endorsement from functional lines.
Document options and proposals for solution governance on how best to meet customer needs.
Drive impact assessments of business requirements and technical changes, which include the identification of processes and applications, required changes to these processes and applications, and alternatives to mitigate impact.
Collaborate with functional lines to understand and document the use of the information management solutions with the business process.
Coordinate user testing and acceptance of information solutions prior to deployment.
Work with key stakeholders to listen to their needs and articulate into projects and provide ongoing status on progress of key projects.
Collaborate with partners, stakeholders, and team members to manage solution roadmaps.
Lead continuous improvement projects to simplify and improve system use and system management.
Lead medium to large projects, following established methodologies.
Collaborate with functional lines to ensure a consistent approach with business process-specific training.
Drive active decision making through pre-existing governance with a complex set of stakeholders.
Provide direction to junior level team members supporting owned project work and work activities.
Domestic and International travel of 10-20% (as required)
Qualifications/Skills
Education:
Minimum of a bachelor’s degree (BS or BA) with higher academic qualification/degree preferred or equivalent relevant professional experience
MS in Computer Science, Life Sciences, Business, Engineering, Statistics, or a related discipline, preferred.
Prior Experience:
Minimum of 5 years pharmaceutical industry experience in (or supporting) any of the following disciplines: clinical drug development, clinical trial management, clinical project management, R&D reporting and analytics, or regulatory affairs. Related experience in other industries will be considered.
Experience with regulated systems used in pharmaceutical industry or other GxP area.
Demonstrated knowledge of application system management and change control processes, application validation and implementation in a GxP environment.
Knowledge of healthcare and/or pharmaceutical metadata and standards.
Experience in pharmaceutical or healthcare AI and automation applications preferred.
Fluent English
Competencies:
Action oriented and energetic.
Easily makes connections - Quick to establish trust and respect.
Extensive computer use.
Demonstrated strong analytical skills with ability to investigate and solve unusual and complex problems independently.
Demonstrated strong customer relationship skills and capabilities to influence and collaborate with teams.
Proven ability to communicate complex information and analyses to a variety of audiences in both verbal and written format, capable of effectively summarizing abstract concepts into clear, concise, and insightful business cases.
Proven ability to operate in a fast-paced, high-energy environment and comfort with operating in situations with significant ambiguity.
Engages in continuous learning; shows commitment to being familiar with new regulations and industry standards, new technology, and new processes that impact Clinical Operations.
DOMAIN COMPETENCIES
Experience in building/managing solutions in one or more areas of Clinical Trial Recruitment, Study Design, Study and Site Management, and Data Management and Monitoring.
Experience implementing business process management (BPM) solutions in the clinical space including, requirements, design, development, testing and change management activities. Demonstrated understanding of the pharmaceutical industry, software development lifecycle and Agile implementation practices. Product owner experience would be a plus
Experience providing data analysis, reporting and building visualizations for solutions across clinical Solutions. Understanding of database querying and data system management in order to assist resources with work assignments. Knowledge of SQL, Alteryx, Spotfire would be a plus
Please apply by sending your CV and a motivational letter in English
Work Location Assignment: Hybrid
Purpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Flexibility
We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
Disability Inclusion
Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!