IT PM-locals

local only

must have

Pharma Industry Experience

Strong project management – over 10 years of experience

PMP or Safe certification

This role will be overseeing the alignment of IT projects with broader business objectives while ensuring regulatory compliance and fostering innovation. This role involves managing the entire project lifecycle, from planning to execution, stakeholder management, risk mitigation, and vendor coordination. Required skills include strong communication, project management, and technical expertise, along with extensive experience in the pharmaceutical or biotech industry.

The project list is changing based on the roadmap and the discussions they are having but it includes but is not limited to, External Collaborative Authoring tool for R&D, External Collaborative Authoring tool for Ops, IRT system implementation (TBD), CMDB, PV Safety Database, PV Safety Doc repository. This person will not be doing all of these but they will prioritize specific projects. Most of these projects are either in requirements gathering stage or with procurement, there are some in flight projects that they might need to put IT PM support on the ground for to review IT documentation from implementation partners and to co-ordinate the IT aspects of the project.

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

Important Skills

Technical – Agile, Pharma background

Soft – strong communicator, leadership skills, problem solver

Interview Process: 3 rounds

Job Title: IT PM

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.

Responsibilities

Project Planning and Execution:

• Provide tactical and team leadership throughout the project lifecycle, overseeing the development of all project deliverables, including the charter, requirements, detailed design, test plan, etc.
• Ensure execution of all activities to meet the defined scope, schedule, budget, and resources, incorporating strategic planning and resource allocation for optimal efficiency.
• Define change and change management approach, identifying interdependencies with other planned work efforts to ensure cohesive project progression.
• Facilitate meetings and communications throughout the project lifecycle to build project momentum and ensure transparency of relevant project information to appropriate audiences.
  
  

Stakeholder Management

• Ensure effective convening and communication with project team members, stakeholders, and senior leadership, including status updates, solutioning, risk/issue management, and key decision-making processes.
• Establish and nurture relationships with customers, project stakeholders, and sponsors to ensure alignment and support throughout the project.
• Lead and facilitate functional and business impact analysis of solution options, conducting trade-off analysis to achieve project objectives and manage risk.
  
  

Regulatory Compliance And Governance

• Responsible for ensuring the project complies with established enterprise project portfolio management governance and processes, including intake, quarterly reviews, and annual planning. This includes adherence to Computer Systems Validation (CSV) principles and the Software Development Life Cycle (SDLC) methodologies, ensuring IT solutions are developed, tested, and implemented in compliance with regulatory standards and best practices.
• Integrate compliance checks and reviews at critical milestones, maintaining documentation and audit trails for regulatory review and internal audits. Emphasize the importance of CSV and SDLC in the context of project delivery, ensuring all software and systems are validated for their intended use in a controlled and regulatory-compliant manner.
• Prepare for and ensure compliance with the stage gates for the project, aligning project milestones with regulatory requirements and internal governance standards. This involves coordinating with compliance and risk management and quality assurance teams to ensure that all project activities, from design to deployment, meet the stringent criteria set forth by regulatory bodies and internal policies.
• Facilitate the documentation and approval processes associated with stage gate reviews, ensuring that each phase of the project meets the predefined criteria for progression, and addressing any compliance gaps prior to moving forward. This structured approach guarantees that the project adheres to both internal governance frameworks and external regulatory expectations, minimizing risk and enhancing the overall quality and reliability of the IT solutions delivered.
  
  

Risk Management

• Enhance risk management strategies to include comprehensive analysis and mitigation of project risks, emphasizing the importance of identifying new risks as the project evolves.
• Implement risk response strategies proactively, maintaining a risk register to track and monitor risks, ensuring transparency and accountability.
  
  

Vendor And Resource Management

• Working with Head of IT, IT Portfolio Leader and SS&P, align vendor and resource management efforts with project needs, ensuring that teams have the necessary skills and resources, and that vendors deliver according to contracts.
• Focus on performance management for vendors, including regular reviews and feedback mechanisms to ensure quality and adherence to agreements.
  
  

Continuous Improvement

• Lead the effort in conducting post-project reviews to capture lessons learned, identifying opportunities for improvement in project management practices.
• Advocate for the adoption of agile practices, automation tools, and other innovations that promise to enhance project delivery and IT operations, ensuring the IT function remains agile and responsive to the evolving business landscape.
• Lead initiatives aimed at the continuous improvement of IT project management processes and practices within the organization. This includes identifying opportunities for enhancing methodologies, tools, and techniques used in managing IT projects, with a focus on increasing efficiency, effectiveness, and adaptability.
• Champion internal projects that aim to refine and advance the IT function. This involves evaluating current methodologies and implementing improvements to streamline operations, reduce errors, and ensure compliance with regulatory standards in a more efficient manner.
• Facilitate cross-functional collaboration to drive innovation within the IT department. Work with teams across IT and business units to identify pain points and inefficiencies in existing processes, and spearhead projects to address these challenges, leveraging technology and process improvements to enhance overall performance.
  
  

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.