IT Project Manager
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Job Description
Title: IT Project Manager
Location: Remote mostly but then come onsite once a month for Institute week (2nd week a month) must be local; One Kendall Square Building 600 3RD FL Cambridge MA 02139
Duration: through the end of the year
Start: ASAP
Visa: USC GC
Important Skills
Technical Agile Pharma background
Soft strong communicator leadership skills problem solver
Interview Process: 3 rounds
Job Description:
The IT PM is a pivotal role for Gates MRI IT requiring a sophisticated blend of technical expertise industry insight and project management acumen. This position is central to aligning IT project deliverables with broader business objectives underlining a dedication to excellence fostering innovation and maintaining regulatory compliance. This individual will be at the forefront of orchestrating comprehensive IT solutions that bolster business goals adhere to stringent regulatory standards and enhance the efficiency of research development and enterprise operations. A track record of managing complex IT projects in the pharmaceutical environment highlighted by strong leadership strategic navigation and effective stakeholder engagement is crucial.
The responsibilities of an IT Project Manager include overseeing the entire project lifecycle from initial planning and execution to final closure ensuring projects align with business and IT strategies. The PM will be responsible not only for solution delivery which encompasses all solution modalities from custom solution builds to Software as a Service (SaaS) Platform as a Service (PaaS) or procuring applications but also the delivery of internal IT projects that may include continuous improvement and strategic efforts. The role demands effective stakeholder communication rigorous compliance with industry regulations adept risk management and working with the Head of IT and the IT Portfolio Leader strategic resource allocation. Lastly the PM will be responsible for providing project leadership to the project team members and will partner with cross functional teams to ensure that the projects meet both business value and are completed under budget and on schedule.
Required Technical Knowledge/Experience/Skills:
- GxP Regulations (FDA EMA ICH) including FDA 21 CFR Part 11 ICH E6(R2)
- Clinical Trial Data (STDM ADaM DTD eCTD/XML)
- Nonclinical Study Data (SEND)
- Safety Data (ISO/HL7 27953: E2B(r2) E2B(r3); ICSR PADER PSUR DSUR)
- PV Safety Databases/Technologies EDC Platforms IRT Platforms Document Management Technologies e.g. Veeva CTMS Technologies ePRO etc.
Required Work Experience:
- Advanced degree in computer science technology engineering or related disciplines required.
- 7 years pharmaceutical/biotech company or consulting experience required.
- Experience in IT project management in both an enterprise and clinical setting
- A proven track record in navigating the unique challenges and regulatory environments of these sectors is essential
- Extensive experience in managing relationships and projects involving heavily outsourced partner/vendor organizations including Contract Research Organizations (CROs) and Functional Service Providers (FSPs). Skill in overseeing vendor performance and ensuring deliverables meet project standards and timelines.
- Experience implementing data platforms and services.
- Experience in project managing the deployment of IT applications relevant to the Pharma Industry such as Clinical Trial Management Systems (CTMS) Electronic Data Capture (EDC) systems Laboratory Information Management Systems (LIMS) and Pharmacovigilance (PV) systems.
- A solid background in managing projects for customdeveloped cloudbased solutions as well as as a Service offerings (IaaS SaaS PaaS) demonstrating versatility and adaptability in leveraging cloud technologies to meet business needs.
- Experience working with and implementing regulated systems in a GxP regulated industry; Computer Software Validation (CSV) and IT SDLC
- Advanced degree in computer science technology engineering or related disciplines required.
Employment Type
Remote
Key Skills
- IT Experience
- Project Management Methodology
- Project / Program Management
- IT Project Management
- Agile
- PMBOK
- Visio
- Waterfall
- Project Management
- Microsoft Project
- Project Management Lifecycle
- SDLC
