IT Project Manager with Pharma
Location
Cambridge, MA | United States
Job description
Job Title: IT PM
Skills & Abilities:
- Superior communication (verbal and written) and presentation skills with the ability to effectively advocate technical solutions and results to technology and business audiences.
- Must be able to effectively prioritize and plan; must have the ability to address multiple projects and adapt to changing priorities.
- Ability to work independently and collaboratively with cross-functional/inter-departmental teams and within the framework of the Enterprise Operations IT organization.
- Ability to manage relationships with all project stakeholders, ensuring their needs are understood and addressed while keeping the project aligned with its objectives.
- Self-motivated and passionate to learn and adopt new technology and nimble, pragmatic methodologies. Must be able to deal with ambiguity, work through issues with agility but without compromise to best practice processes and documentation.
- Team-oriented and generous in sharing knowledge and enabling others.
- Strong facilitation skills to lead teams to establish consensus, ensure clarity and decisions/justifications.
- Effective negotiation and persuasion skills to manage stakeholder expectations.
- Ability to inspire, motivate, and guide team members towards achieving project goals, fostering a collaborative and positive work environment.
- Excellent time management and the ability to prioritize tasks effectively.
- Capacity to analyze challenges, consider various solutions, and make decisions that steer the project forward in the face of obstacles.
- Capacity to evaluate situations, data, and feedback critically to make informed decisions that align with project and organizational goals.
- Creative and critical thinking skills to develop innovative solutions to business challenges.
- Ability to work effectively in a diverse work environment, respecting and valuing diverse backgrounds and perspectives
Required Technical Knowledge/Experience/Skills:
- Familiarity with current IT technologies, platforms, and tools, including cloud computing, data analytics, cybersecurity measures, and enterprise software solutions. Ability to leverage technology to drive project success and operational efficiency.
- Strong Pharma/Life Sciences experience with an in-depth understanding of Clinical Development and Operations processes
- Strong understanding and working knowledge of:
- 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)
- Experience working in a Computer System Validation (CSV) process and SDLC process.
- Understanding and experience with Pharma related Technology Solutions/Platforms, including but not limited to:
- PV Safety Databases/Technologies, EDC Platforms, IRT Platforms, Document Management Technologies e.g. Veeva, CTMS Technologies, ePRO, etc.
- Understanding of software development processes and methodologies (e.g., Agile, Scrum, Waterfall, SDLC).
- Deep understanding of and proficiency in various project management methodologies, including Agile, Scrum, Waterfall, and Lean. Ability to apply the appropriate methodology to match project needs and organizational culture.
- Holding relevant certifications (e.g. PMP, SaFe) or formal training in project management, with extensive experience in leading and managing projects
- Able to analyze complex data to identify trends, patterns, and insights utilizing modern IT tooling.
- Any relevant certifications (e.g., CBAP, PMI-PBA) or formal training in business analysis and solution development
- Proficiency in using analytical tools and software for data analysis.
- Understanding of technical IT issues to organize discussions with internal and external technical specialists.
- Skills in identifying, assessing, and managing project risks. Ability to develop comprehensive risk mitigation and contingency plans to ensure project success.
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 custom-developed cloud-based 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.
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