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Job Title: Project Manager / Business Analyst for R&D Capabilities
Duration: 6 Months
Location: Cambridge, MA
Target Start Date: July 15th
Time to Start Interviews: Now
Description of Role:
Project Manager / Business Analyst for R&D Capabilities will be responsible for managing and tracking all activities associated with the development and/or enhancement of new business capabilities including in the R&D space. This will include but not limited to business process definition, operational model definition, system implementation, training, and communication planning for these capability builds as well as support for post implementation and system administration activities. The Project Manager / Business Analyst for R&D Capabilities will bring their expertise to bear in guiding business users through the capability build and managing to project success criteria through project dashboard/status updates, stakeholder management, vendor management timeline management, and tracking of key risks, issues, activities, and deliverables. Further, the Project Manager / Business Analyst for R&D Capabilities will be responsible for the development of project documentation including business process maps, business procedure documentation, IT SDLC project documentation, training materials, and communication materials required to evangelize the implementation the capability.
Specific Projects / Required Experiences / Systems Experience Needed:
Experience managing and implementing life sciences content management systems including:
Statistical System Architecture and Support (DWise, Pinnacle21) evaluate current environment, help support existing environment, review scalability plans, develop future architecture / support model, lead implementation of future solution (~70%)
Electronic Trial Master File System Veeva evaluate current eTMF capability (~15%)
Clinical Trial Transparency (CTT) Xogene lead implementation of CTT solution (Xogene) (~10%)
Electronic Lab Notebook (eLN) aid in develop of eLN roadmap (~5%)
Experience partnering with business leads to evaluate and document business requirements and use cases
Experience managing successful projects including project dashboard/status updates, stakeholder management, vendor management, timeline management, and tracking of key risks, issues, activities, and deliverables
4+ years working in a regulated pharmaceutical organization, CRO or FSP
10+ years as a project manager and business analyst
Must Haves Skills:
Leadership of business capability development and IT system implementation projects
Ability to communicate effectively with stakeholders at all levels of a matrix organization
Ability to work in a collaborative team environment willing to pitch in to achieve goals and maintain relationships with business leads, stakeholders, business users, technical team, validation, quality, and vendor resources
Ability to work independently and with minimal supervision
Demonstrated ability to establish and meet priorities and deadlines
Experience with timeline management and resource / capacity management
English as a first language or excellent written and spoken English fluency
Day to Day Responsibilities:
The role will be responsible for managing a portfolio of projects in the R&D areas. The role will responsible for partnering with business leads to understand business use cases and develop user/functional requirements, developing projects plans for IT systems and associated process and organizational support, creating and submitting status reports and tracking project level issues, risks, decisions and overall status, and identifying and tracking key interdependencies between projects. The role will meet with key business stakeholders to establish project meeting cadence, set up meetings and drive project execution. Role will take meeting minutes and manage IT project management tools and drive creation of key IT SDLC documentation.
Experience Implementing lab systems
Experience running eLN and eTMF systems
Clinical data / analytical systems
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