Senior Project Manager/Business Analyst, Life Sciences

vor 4 Wochen


Frankfurt am Main, Hessen, Deutschland fme US, LLC Vollzeit

About fme US, LLC:

fme US, LLC focuses on delivering business solutions in the Life Sciences industry, leveraging enterprise content services platforms for clients. Our company is a trusted vendor and partner, working with clients ranging from small start-ups to large global pharmaceutical companies. We provide business consulting, systems integration, and ongoing support services, focusing on Content Services and its applicability to business-critical solutions, including RIM, Regulatory, Clinical, and QMS. fme US, LLC is partnered with leading Business Solutions and ECM vendors, such as Veeva Vault, OpenText Documentum, Generis CARA, Honeywell TrackWise, and Alfresco.

Our priority is client satisfaction and assisting them in determining the most effective way to deploy mission-critical technologies. We focus on three aspects: business process consulting, technology platform implementations, managed services, and data/document migration services. This ability to provide business insight and execute efficiently and cost-effectively is a crucial feature of our services and differentiates us from our competition.

Job Description:

As a Project Manager/Business Analyst in Life Sciences, you will drive project management and business analysis activities for Life Sciences projects. You will lead and manage projects from initiation to completion, ensuring they are delivered on time, within budget, and to client specifications. Additionally, you will support business technology and migration consulting projects, primarily in Regulatory Affairs. This includes gathering business and functional requirements, facilitating workshops to define new business processes and data architectures, and driving user adoption through training and change management activities. You will also document content and data migration transformation mapping rules, support validation, and user acceptance testing (UAT).

Key Responsibilities:

  • Project Management:
    • Establish and maintain program governance structures and processes, including regular meetings, reporting mechanisms, and decision-making frameworks across fme US, LLC and client leadership.
    • Lead client-facing meetings with technical lead support and hold regular technical team meetings to measure progress, address questions, and support the remediation of project challenges.
    • Lead and provide direction and guidance for a wide array of activities associated with project planning and management to ensure that all assigned projects are completed on time, within budget, and to client specifications.
    • Monitor the performance of projects, tracking key metrics and milestones to assess progress and identify areas for improvement.
    • Serve as the primary point of contact for project stakeholders, including senior management (client and fme US, LLC), client project management, and external partners, communicating program status, risks, and issues regularly.
    • Assign and oversee daily tasks of the designated technical personnel in collaboration with the technical lead to ensure adherence to the project timeline and completion of tasks in alignment with established project milestones.
    • Identify and mitigate risks and issues that may impact project delivery, working closely with project managers and stakeholders to develop mitigation strategies.
    • Adhere to the ISO 9001: Quality Management standard and processes and confirm project deliverables meet quality standards and comply with relevant regulations and requirements.
    • Adhere to fme US, LLC formal project management methodology for all projects.
    • Main point of contact and accountable for the management of changes to project scope, schedule, and budget, assessing the impact on the program and implementing appropriate change control processes.
  • Business Analysis:
    • Conduct a thorough process analysis to identify efficiency opportunities and improvements.
    • Analyze business and functional requirements, ensuring comprehensive documentation and clarity.
    • Develop and document source-to-target content and data mapping and rules within the Mapping Specification.
    • Conduct data quality reviews and gap assessments to support migrations.
    • Support change management and communication activities to foster a success-oriented and accountable environment.
    • Prepare regular written and verbal presentations, technical documents, and reports.
    • Work effectively in a team, taking on different roles as needed based on project requirements.
    • Manage multiple tasks in a fast-moving, ambiguous environment, demonstrating resourcefulness in setting priorities.
    • Contribute to the strategic elements of migration plans, ensuring a clear and concise description of the overall migration process.


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