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Senior Clinical Data Specialist, Information Management (Sr.


Groton, CT
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Job Details

Job Title Senior Clinical Data Specialist, Information Management (Sr.

JobID 1047239-1852

Location: Groton, CT

Description *About Pfizer*

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.

*Role Description*

Manage projects as they relate to Pfizer's Clinical Data Management Systems (CDMS). Analyze multiple models/systems to ensure data integrity and documented, defensible collection/management of these data. Partner with global Clinical Trial Process Quality (CTPQ) regarding process across models.Leads operational/strategic team(s) within and across functions and lines. May chair multidisciplinary teams and participate on specialty councils supporting Pfizer clinical systems.Provide subject matter expertise at the crossroads of technology and process being utilized within the Pfizer controlled environment. Responsible for identifying, leading, and supporting strategic initiatives within information management to enhance operational efficiencies using systems and system enabled processes. Provide support and escalation for operational services for Pfizer studies in DataLabs, InForm, Oracle Clinical and any/other related tools. The CDS position will collaborate with other Subject Matter Experts within information management, Strategic Partners, and other external vendors as appropriate.Serves as escalation points for study teams, Asset leads and Clinical Research OperationsSupport Leads. The CDS is able to bridge gaps between Pfizer and partner systems for technical and process related troubleshooting and has the ability to easily transition from project to project as needed while maintaining connections to the innovation team and other external groups to Development Operations. The CDS works across partner systems, applications and processes.The CDS will also partner with the Information management team regarding the Clinical Aggregation Layer (CAL), ensuring CDMS systems/processes are consistent with the needs of the CAL. Further partnerships include, but are not limited to CTPQ and the Center of Excellence (CoE).The CDS will support and maintain all business related enterprise level activities regarding Pfizer's use of clinical systems and provide subject matter expertise and/or escalation support and guidance to Development Operations China (DOC and other partner organizations and companiesThis is a vital role lending towards the ultimate objective of data quality and consistency across programs and systems. The CDS creates, maintains and assumes accountability for a culture of high customer service using tools to facilitate communication, transparency of operations, clarity of workload balance, and alignment on priorities. The CDS maintains multifunctional collaborations leveraging their expertise and overall business understanding to lead the strategic efforts in maintenance as well as continuous improvement.


Process and Standards* Interface with CTPQ organization, Business Process Owner Network and other InformationManagement colleagues to further standardize and optimize Pfizer's processes and practices* Actively identify continuous improvement opportunities to enhance operational efficiencies through process and metrics analysis* Participate and lead efforts to develop processes, standards and training as they relate to the technology-enabled clinical trial processes* Promote the use of consistent, efficient, and quality processes to meet timelines and deliverablesCustomer Outreach* Plan and execute communication plans & methods for engaging customer populations (e.g., newsletters, websites, user groups)* Interface with customers on solutions, requirements, continuous improvement, deployment change management, user groups and workshops, etc* Understand customers and stakeholders and ensure they are satisfied with support services and systems* Build & maintain knowledge-base (e.g., FAQ)* Communicate key project status and to various levels within the organization* Implement business strategies and technology-enabled processes and tools in close partnership with appropriate groups in Business technology, DOC, Developments Japan, and other partner organizations and companies (including Business impact assessments and AIM deliverables)* Coordinate and oversee vendors across various needs (e.g., Tier 1 services, quality management, data management, study start up, electronic data, etc)* Define scope of outsourced work and establish work instructions / task ownership matrices / escalation paths / SLAs for vendors providing services* Establish oversight plans and metrics associated with outsourced servicesGeneral* Provide subject matter expertise in technology and process being utilized within the strategic partnership.* Demonstrate the ability to follow information flow between vendor and Pfizer systems.* Actively identify and bridge gaps between Pfizer and Partner systems for technical and process related issue management.* Easily transition from project to project as needed while maintaining connections to the innovative team and other external groups to CoE.* Work across Partner systems, applications and processes. Interact with and support DOC andDev Japan as it related to CDMS* Collaborate with business process owners and information technology, as appropriate, to support potential changes or improvements related to systems and processes.* Manage queries from the organization related to technology and processes.* Able to resolve conflicts, influence and communicate with key stakeholders and user groups.* Support rapid response, audit and inspection needs.* Work proactively with Training representatives to develop training strategy including recommending curricula assignments, materials development and communications required to support the roll out of revised processes.


Bachelor's degree or equivalent experience in a scientific discipline required* At least 10-15 years of increasingly responsible positions within the pharmaceutical industry including substantial eclinical data and process leadership activities.Prior Experience:* Technical expertise and business process support in systems supporting clinical trials (document management, data acquisition, data management, trial management, reporting, etc)* Thorough understanding of the processes associated with clinical study management, data management, and regulatory operations* Demonstrated project management skills (multiple complex projects)* Project management, resource management (staff and financial), administrative, and technical capabilities are required ,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 lead 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 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 complex problems* As applicable: Extensive knowledge of data management processes and principles in the specialty: CRF Design, Data Base Development, Randomization, Data Loading, EDC, e-Diaries, CRF Processing, Submission Assembly or Validation Procedures* Working knowledge of the principles and concepts of other disciplines* 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.

*Senior Clinical Data Specialist, Information Management (Sr.*
*Groton, Connecticut*

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