Manager, Informatics Operations and Project Management- Vaccine R&D
Pearl River, NY
ID: 7114480 (Ref.No. 4862899)
Posted: October 24, 2022
Application Deadline: Open Until Filled
We live in a world of fast knowledge creation supported by technology platforms. Pfizer’s digital and ‘data first’ strategy looks to accelerate the delivery of impactful technology solutions for research, development and medical functions. We also look to constantly improve our skills by collaboration and information sharing through business technology to help employees find the best healthcare solutions for our patients. You will be working with a team of innovators who keep our systems up and running as well as our information secure. We need dedicated colleagues like you to enhance patients’ quality of care through new ideas and innovative information technology solutions.
What You Will Achieve
The qualified individual will utilize knowledge of informatics, project management, clinical research operations, laboratory operations, and GxP regulatory processes to lead a sub-function within the Research Informatics group focused on overall support of laboratory information systems. The customer base consisting of clinical labs, sample management, data management, external collaborations, and automation/robotics have a wide array of custom needs found throughout early to late phase clinical testing, complex epidemiology, exploratory research experimentation, and in-vivo assays.
The individual will partner and act as the “glue” between Senior management, Informatics Support team, Information System Architects, Software Engineers, Application Developers, Data Analysts, Business Analysts, Statisticians, and various laboratory stakeholder groups to ensure information systems are developed, maintained and available for customer use. The Informatics Project Lead will ensure efforts around project scope, project timelines, business analysis, software testing/validation (SDLC tasks), change control, customer communication, and project management are delivered in a timely fashion. Coordination and collaboration are at the center of the role, and the individual will have to juggle priorities of emergencies, “nice-to-have” requests, and broader needs across many stakeholders, partners, and technical analysts. Expertise will be focused on the entirety of the VRD software needs that include LIMS products, SAS programs, R-shinny applications, databases, scripting tools, and one-off applications built in new technologies.
The individual will have strong communication and collaboration skills; s/he will be expected to bring people together to deliver on day-to-day and large-scale projects. S/he will partner with system architects, software engineers, application developers, scientists, statisticians, clinicians, etc., often taking the lead on multiple teams. Many documents related to regulatory validation requirements will be authored, reviewed, approved, and shepherded along by the project team that the individual assembles. These documents include project plans, system requirements, test scripts, validation summary reports, etc. Work will occur on-site with periodic work-from-home available. Minimal travel is expected. To succeed, the individual will work in close collaboration with Research Informatics leads and will spend some of his/her time leading one or more teams of direct/indirect reports and potentially consultants focused on the varied aspects outlined above as related to operations, compliance, and support of information systems. The individual will ultimately take “big picture” direction from and regularly communicate with the Informatics Operations & Support Director.
How You Will Achieve It
Partner with stakeholders from various departments and perform project management functions to ensure data collection and analysis systems are developed/upgraded to meet VRD clinical trial needs.
Manage one or more teams of direct/indirect reports and/or consultants to bring projects to on-time completion.
Ensure procedural documentation is completed as per SOP.
Lead change control discussion for data analysis updates.
Ensure deadlines for projects are properly established and communicated.
Ensure projects are appropriately resources for successfully completion, and if not, clearly communicated.
Ensure processes are in place to collect requirements (business analysis) and test systems (validation engineering) as per SDLC.
Effectively lead transitions between various stakeholders to shepherd projects to completion.
Write departmental SOPs; maintain technical/SDLC paperwork and migrate such data to archive repository.
Assign tasks to, establish milestones for, and mentor direct reports; closely supervise consultants tasked with various workload and deadlines.
Administer select systems and potentially do minor programming or querying.
Maintain highest minimum compliance required by regulatory standards.
Bachelor's Degree in Computer Science, Information Systems, or Life Sciences (with systems focus) plus tangible, extensive work experience of at least 8 years.
Project management and supervisory experience required.
Extensive knowledge of LIMS and data analysis software required.
Experience with understanding reporting tools to extract data for visibility/further scientific analysis.
Operational experience within regulated laboratories required.
Experience with SDLC and regulated documentation (beginning-to-end) required.
Expertise within the pharmaceutical or R&D environment.
Strong oral and written communication skills.
Able to evaluate and re-prioritize activities in a changing environment.
Ability to effect change and influence people with the goal of achieving a viable solutions
Master's degree and relevant pharmaceutical experience.
Experience managing people, both directly and indirectly.
Experience performing biological assays.
Relocation support available
Work Location Assignment: Flexible
Other Job Details:
Eligible for relocation package
Eligible for employee referral bonus
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.