ESR Healthcare
Sr. Project Manager - Life Sciences Santa Rosa, CA, 95402
ESR Healthcare, Santa Rosa, California, us, 95402
Sr. Project Manager - Life Sciences
Is your CV ready If so, and you are confident this is the role for you, make sure to apply asap. Santa Rosa, CA, 95402 Here is an opportunity for you to make a difference and collaborate with global leaders to shape the future of healthcare and positively impact human lives. Our vision: To inspire new possibilities for the health ecosystem with technology and human ingenuity. We focus on building highly motivated engineering teams and thought leaders with an entrepreneurial mindset, centered on our core values of Passion, Respect, Openness, Unity, and Depth (PROUD) of knowledge. Our success lies in creating a fun, transparent, non-hierarchical, diverse work culture that focuses on continuous learning and work-life balance. Rated by our employees as the Great Place to Work for according to the Great Place to Work survey. We offer you a comprehensive set of benefits to ensure that you have a long and rewarding career with us. Role: We are seeking an experienced Project Manager to lead the design, development, and deployment of a GxP-compliant AI/ML platform for medical imaging and RWD on AWS. Requirements to succeed: 15+ years of experience in a combination of IT services industry and life sciences, Medtech, Medical imaging or similar related fields. Experience managing cross-functional teams while ensuring regulatory compliance, and aligning with business objectives. Experience managing projects involving AWS technologies (e.g., S3, EC2, Lambda, SageMaker, RDS). Prior experience working in an offshore/onshore engagement model with ownership of technical outcomes. Strong knowledge of GxP regulations. Responsibilities: Delivering this critical project on time, within scope, and budget, while ensuring adherence to regulatory frameworks and quality standards. Project planning, strategy, execution, and delivery: Develop and manage scrum teams, project roadmaps, objectives, and timelines. Define KPIs, success criteria, and risk management plans. Align project milestones/goals to ensure adherence to the committed objectives. Coordinate with engineering, data science, product, compliance, and operations teams to ensure seamless platform development and deployment. Monitor progress, track milestones, and manage dependencies across multiple workstreams. Drive Agile ceremonies such as sprint planning, retrospectives, and stand-ups. Regulatory & Compliance Management: Ensure the platform adheres to GxP compliance and meets relevant regulatory requirements (e.g., FDA, EMA). Collaborate with QA, validation, and compliance teams to ensure proper documentation and controls (e.g., validation protocols, SOPs). Monitor adherence to AWS Well-Architected Framework for GxP workloads. Stakeholder Communication & Reporting: Serve as the primary point of contact for senior stakeholders, including executives, clinical teams, and external partners. Provide regular updates on progress, risks, and mitigation strategies through dashboards and reports. Manage vendor relationships with AWS and third-party service providers. Budget & Resource Management: Manage program budgets, ensuring optimal allocation of resources. Identify and escalate resource constraints or financial risks. Must have skills/expertise: Expertise in Agile methodologies (Scrum, SAFe). Strong project management tools expertise (JIRA, MS Project, or similar). Excellent stakeholder management and communication skills. Ability to manage cross-functional teams and vendors effectively. Analytical mindset with strong problem-solving skills. Nice to have (Preferred) skills & Certifications: Prior experience managing large-scale AI/ML platform integrations. An understanding of medical imaging technologies (e.g., DICOM, PACS) and RWD frameworks would be advantageous. Certifications: PMP, PgMP, or Agile certifications (CSM, SAFe). Familiarity with machine learning frameworks and data governance policies. Experience working with regulated environments (FDA, EMA). Educational Qualifications: Bachelor's or Master's degree in Life Sciences, Computer Science, Engineering, or related fields. Location: San Francisco, CA (preferred) with partial on-premises presence.
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Is your CV ready If so, and you are confident this is the role for you, make sure to apply asap. Santa Rosa, CA, 95402 Here is an opportunity for you to make a difference and collaborate with global leaders to shape the future of healthcare and positively impact human lives. Our vision: To inspire new possibilities for the health ecosystem with technology and human ingenuity. We focus on building highly motivated engineering teams and thought leaders with an entrepreneurial mindset, centered on our core values of Passion, Respect, Openness, Unity, and Depth (PROUD) of knowledge. Our success lies in creating a fun, transparent, non-hierarchical, diverse work culture that focuses on continuous learning and work-life balance. Rated by our employees as the Great Place to Work for according to the Great Place to Work survey. We offer you a comprehensive set of benefits to ensure that you have a long and rewarding career with us. Role: We are seeking an experienced Project Manager to lead the design, development, and deployment of a GxP-compliant AI/ML platform for medical imaging and RWD on AWS. Requirements to succeed: 15+ years of experience in a combination of IT services industry and life sciences, Medtech, Medical imaging or similar related fields. Experience managing cross-functional teams while ensuring regulatory compliance, and aligning with business objectives. Experience managing projects involving AWS technologies (e.g., S3, EC2, Lambda, SageMaker, RDS). Prior experience working in an offshore/onshore engagement model with ownership of technical outcomes. Strong knowledge of GxP regulations. Responsibilities: Delivering this critical project on time, within scope, and budget, while ensuring adherence to regulatory frameworks and quality standards. Project planning, strategy, execution, and delivery: Develop and manage scrum teams, project roadmaps, objectives, and timelines. Define KPIs, success criteria, and risk management plans. Align project milestones/goals to ensure adherence to the committed objectives. Coordinate with engineering, data science, product, compliance, and operations teams to ensure seamless platform development and deployment. Monitor progress, track milestones, and manage dependencies across multiple workstreams. Drive Agile ceremonies such as sprint planning, retrospectives, and stand-ups. Regulatory & Compliance Management: Ensure the platform adheres to GxP compliance and meets relevant regulatory requirements (e.g., FDA, EMA). Collaborate with QA, validation, and compliance teams to ensure proper documentation and controls (e.g., validation protocols, SOPs). Monitor adherence to AWS Well-Architected Framework for GxP workloads. Stakeholder Communication & Reporting: Serve as the primary point of contact for senior stakeholders, including executives, clinical teams, and external partners. Provide regular updates on progress, risks, and mitigation strategies through dashboards and reports. Manage vendor relationships with AWS and third-party service providers. Budget & Resource Management: Manage program budgets, ensuring optimal allocation of resources. Identify and escalate resource constraints or financial risks. Must have skills/expertise: Expertise in Agile methodologies (Scrum, SAFe). Strong project management tools expertise (JIRA, MS Project, or similar). Excellent stakeholder management and communication skills. Ability to manage cross-functional teams and vendors effectively. Analytical mindset with strong problem-solving skills. Nice to have (Preferred) skills & Certifications: Prior experience managing large-scale AI/ML platform integrations. An understanding of medical imaging technologies (e.g., DICOM, PACS) and RWD frameworks would be advantageous. Certifications: PMP, PgMP, or Agile certifications (CSM, SAFe). Familiarity with machine learning frameworks and data governance policies. Experience working with regulated environments (FDA, EMA). Educational Qualifications: Bachelor's or Master's degree in Life Sciences, Computer Science, Engineering, or related fields. Location: San Francisco, CA (preferred) with partial on-premises presence.
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