Pfizer Information Manager in Groton, Connecticut
A career at Pfizer offers opportunity, ownership and impact.All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
This position sits within the Clinical Data Management Solutions (CDMS) Team within Information Management - Clinical Trial Solutions. This role will support the Center of Excellence (CoE) and their partners including Data Management and Monitoring (DM&M), Clinical Trial Process and Quality (CTPQ), Clinical Programming, and Business Technology (BT) to deliver integrated process, technology and information strategies for CDMS
Design, develop and implement processes, systems and data that deliver a high ROI to CDMS and its partners using industry standard methodologies.Champion cross-functional broad and strategic initiatives, novel concepts and solutions that can be applied to enhance existing solutions or to the introduction of new systems or processes.Consult across CDMS and its partners on all aspects of information use, including retrieval,analysis, integration, organization and management.Draw on broad knowledge of existing solutions and interrelationships to provide ad-hoc consulting on CDMS and enterprise-wide projects as required.Proactively assess the information needs of CDMS and seek out novel approaches to meetthose needs by enhancing, developing solutions.Engage Business Technology on requirements for enabling technologies.Determine procedural and technical system needs, and then develop approach to meeting those needs with client groups and Business Technology.Oversee development plus implementation of procedures and communication strategies,qualitative and quantitative measurement of processes, and recommendations for continuousimprovement.Key contributor to CDMS standards in partnership with other departmental standardsgroups.Oversee and develop documentation: user requirements, functional requirements, useracceptance testing strategy and scripts, procedures/best practice guides, and information needed to create training material.Develop and deliver process & system training.Coordinate and oversee vendors across various needs (e.g., Tier 1 support services, CDMS user access, etc)
Bachelor's degree or equivalent experience in a scientific discipline required* At least 5 years of experience within the pharmaceutical industryincluding substantial eClinical data and process leadership activities.Prior Experience:* Thorough understanding of the processes associated with clinical study management, datamanagement, and regulatory operations* Demonstrated project management skills as well as effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.Technical Competencies:* Demonstrated ability to work on multiple projects* Demonstrated knowledge of clinical development process including in depth knowledge and understanding of the principles of GCP* Proven ability to define clear, streamlined processes for technologies supporting clinical trials* Knowledge/understanding of technologies to support clinical trials, familiarity with software development lifecycle; strong understanding of the state-of the-art technologies to evaluate and leverage them into improved business processes for worldwide deployment and adoption.* Understand customers and stakeholders and adapt messages appropriately* Proven ability to communicate difficult messages to various levels within the organization.* Ability to make complex decisions that require choosing between multiple options* Ability to work in ambiguous situations within the team to identify and resolve complexproblems* As applicable: Extensive knowledge of data management processes and principles in thespecialty: CRF Design, Data Base Development, Randomization, Data Loading, EDC, e-Diaries,CRF Processing, Submission Assembly or Validation Procedures* Works independently and receives instruction primarily in unusual situations* Ability to organize tasks, time and priorities of self and others; ability to multi-task
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.
Information Manager Groton, Connecticut 1053428-1852