Emmes Group

Role Description The Senior Project Delivery Manager (PDM) leads the successful delivery of clinical studies within a technology-enabled clinical research environment, managing increased operational complexity and client expectations. The senior PDM is accountable for study-level outcomes while supporting broader consistency across multiple projects and clients. The Senior PDM partners with sponsors, CROs, technical teams, and internal stakeholders to resolve escalated delivery issues, refine delivery approaches, and support the development of new capabilities. In addition to project delivery, the Senior PDM provides functional leadership within defined pillars and supports lower to medium need client portfolios, contributing to operational maturity and scalability. Responsibilities - Leads delivery of technology-enabled complex and non-standard certification studies and low to medium complexity imaging programs, ensuring commitments for quality, timelines, scope, and budget are met. - Acts as senior client-facing contact for complex or high-risk studies. - Owns study-level outcomes across quality, timelines, budget, and client satisfaction. - Tracks and reports delivery KPIs across projects, identifying trends and areas for improvement. - Oversees multiple studies or workstreams, balancing priorities, resources, and risks. - Serves as Portfolio Specialist for low to moderate need clients, ensuring delivery consistency and proactive issue management. - Supports functional leadership within defined pillars by contributing expertise and driving implementation of process improvements and change initiatives. - Operationalizes functional strategies, ensuring adoption and consistency across delivery practices without owning functional accountability. - Mentors and coaches PDMs and Lead PDAs, strengthening delivery capability and judgement. - Leads resolution of escalated delivery, system, or data issues. - Supports audit readiness and participates in audits or inspections and governance activities at a senior level. - Contributes to refinement of delivery models and onboarding of new capabilities such as imaging and digital capture. - Performs other duties as assigned. - Complies with all policies and standards. Qualifications - Bachelor's Degree Required. - 5 years of experience in project management or delivery leadership roles. Required. - 1-3 years Demonstrated experience managing complex or non-standard projects, client relationships, and delivery risk within regulated or technology-enabled environments. Preferred. - Advanced proficiency with delivery tools, reporting, and KPI tracking across multiple studies or clients. - Strong ability to manage complex, non-standard projects with multiple dependencies and higher risk profiles. - Excellent communication skills, including leadership-level client interactions and escalation management. - Deep understanding of regulated delivery environments, quality systems, and governance expectations. - Ability to mentor other staff, strengthening delivery capability and judgment across the organization. - Strong analytical skills to identify trends, risks, and improvement opportunities across portfolios. Company Description Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry-leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience. - Building a better future for us all. - We believe the work we do will have a direct impact on patients’ lives and act accordingly. - We strive to build a collaborative culture at the intersection of being a performance and people-driven company. - We’re looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. - If you share our motivations and passion in research, come join us! - If you’re looking for a career where your work advances global health and where scientific excellence meets real-world impact, join us and be part of something bigger. - One Team, One Purpose.

Role Description The Clinical Trial Manager (CTM) II is responsible for the execution of operational activities for a study or group of studies at a regional level or within a small group of countries, including tracking progress and quality at clinical sites. The CTM II will lead the monitoring team and associated deliverables, including the clinical monitoring plan, site visit reports, etc. In addition, the CTM II works to ensure clinical trial timelines are being met and communicated to the Project Leader/Global Clinical Project Manager. The CTM II will independently oversee site management and site monitoring activities. Responsibilities - Possesses detailed knowledge of the study/protocol and its associated activities and timelines, leverages operational expertise to design operational strategy for trial execution. - Provides mentoring, training, and independent oversight for in-house Clinical Research Associates (CRAs), CRAs, and site management staff on assigned projects. - Leads operational implementation of a study, including management of tasks and oversight of clinical operations activities specific to each phase of the study lifecycle in accordance with corporate and project-level Standard Operating Procedures, study plans and any client/sponsor requirements or guidelines. - Establishes and maintains strong working relationships with clients, vendors, and internal collaborators. Communicates with internal and external collaborators regarding status of tasks and updates and is responsible for communication of status of activities to internal teams. - Under the guidance of the Project Leader/Global Clinical Project Manager, serves as the client/sponsor-facing point of contact for operational activities as outlined in the study’s Communication Plan. - Leads internal and external operational study calls and meetings, participates in other calls as required. - Escalates issues or concerns regarding study activities to line management and the department leadership as needed. - Leads the development and review of key study plans such as the Manual of Procedures (MOP), Clinical Monitoring Plan (CMP), Standard Operating Procedures (SOPs), pharmacy/lab manuals, TMF plan, etc. Provides operational review of the protocol if applicable. - Leads the development and review of key templates such as master informed consent form(s) and other participant-facing documents, site training materials, annotated report for each visit type conducted for the study, monitoring visit checklists, monitoring correspondence documents, etc. - Responsible for ensuring site document currency and ethics approvals, as applicable. - Ensures study timelines and deliverables are met by CRA staff, including, but not limited to, development of the clinical monitoring plan per the Statement of Work (SOW), evaluation of the risk-based monitoring strategy, monitoring visit frequency, monitoring visit report submission/approval timelines, study data collection timelines, and the annotated reports per the project SOW and/or Emmes SOPs. - Continuously evaluates current operational practices and recommends process improvements to ensure continued compliance with regulatory requirements and industry best practices. - Develops and maintains metrics related to site assessments, feasibility and selection, site activation and close out activities. - Tracks and reports on site performance metrics and quality. Stays up to date on overall study progress at the site(s) and proactively identifies and escalates risk (e.g. recruitment rates, missing data, investigational product inventory and expiration, protocol compliance, safety reporting, regulatory issues, etc.) while providing risk mitigation strategies. - Remains informed of data system progress and data management activities; may serve in a consultative role as it relates to the study protocol and operational guidelines, report development, data collection requirements, eCRF design, etc. - Maintains frequent communication with the safety/medical monitor to ensure adequate safety reporting information is included in key study documents (e.g., protocol, informed consent form) and that safety event reporting is occurring as required. Tracks reporting and follow-up of Adverse Events, Serious Adverse Events, and Suspected/Unexpected Adverse Events. - Responsible for study-level supplies and investigational product/device accountability, including coordination with vendors as applicable. - Tracks documentation and archiving of study documents. - Conducts observational, training, and co-monitoring visits with CRAs as applicable. - Assists with bid defense preparation and conduct and in the RFP/proposal process. - May assist with DSMB/DMC coordination and management. - Other duties as assigned. Qualifications - Bachelor's or a master’s degree, preferably in a science related field. - Typically possesses at least 7-8 years of relevant clinical research experience, including time as a CRA or in a clinical operations coordinating/leadership role. - Excellent team building and interpersonal skills. - Excellent organizational and analytical skills. - Excellent verbal and written communication skills. - Excellent ability to prioritize and handle multiple tasks. - Ability to work independently, as well as in a complex team environment. - Proficient with MS Office Suite. - Excellent computer and organizational skills. - High attention to detail required. - Ability to work on varying projects and exercise critical thinking. - Self-starter who can work independently and a team player who can work cross functionally with limited oversight. - Knowledgeable in clinical research operations, including interpretation and implementation of country-specific regulations/ICH guidelines, as required. - Demonstrated problem-solving skills, self-motivated, and adaptable to a dynamic environment. - Knowledgeable in prioritization, problem-solving, organization, critical thinking, decision-making, time management, and planning activities. - Ability to collaborate with internal and external colleagues and work well in a team-oriented setting. Benefits - Flexible Approved Time Off. - Tuition Reimbursement. - 401k Retirement Plan. - Work From Home Anywhere in the US. - Maternal/Paternal Leave. - Casual Dress Code & Work Environment.

Role Description Designs, develops and writes, evaluates, and modifies SAS computer programs to efficiently and reproducibly analyze and evaluate clinical data. Recognizes inconsistencies and initiates resolution of data problems, including creation of tables, figures, and listings as needed. - Creates standard and custom tables, figures, and listings of clinical data using statistical software (e.g. SAS). - Writes well documented computer code and conducts code reviews and programming validation as needed. - Develops macros (SAS) or functions using statistical software. - Corrects errors by making appropriate changes and rechecking programs to ensure the desired results are produced. - Performs or directs revision, repair, and expansion of existing programs to increase operating efficiency or adapt to new requirements. - Merges data from different sources into a single integrated dataset. - Resolves identified inconsistencies and data problems. - Maintains currency in knowledge of SAS and other statistical software. - Adheres to corporate standards for documentation and validation of statistical programming. - Contributes to project programming activities (e.g. web reports, halting rules, report tables, figures, etc.). - Communicates effectively with internal staff, including effective communication of technical concepts. - Attends relevant statistical functional group activities (e.g. brown bag seminars and workshops). - Presents or contributes to functional group meetings or other activities. - May provide task specific mentorship to other programming staff. - Complies with all policies and standards. - Performs other duties as assigned. Qualifications - Bachelor's Degree in a scientific discipline preferred. - 4+ years of related experience required with Bachelor's degree. - Knowledge of SAS with demonstrated ability to perform programming tasks, such as TFLs, with minimal guidance. - Proven ability to solve problems, especially as it relates to programming. - Demonstrated ability to communicate technical concepts, both written and orally, to nontechnical internal staff. - Prior experience creating tables, figures, and listings for clinical data. - Competency in SAS software, including SAS Macro and SQL extensions. - Strong analytical skills with the ability to process scientific and medical data. - Ability to manage multiple tasks. - Ability to work independently, as well as in a team environment. Company Description At Emmes Group, we’re shaping the future of clinical research—where human intelligence meets cutting-edge technology to drive meaningful advancements in healthcare. With over 47 years of scientific excellence, we’ve led groundbreaking research in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience. Through our two business units—Emmes, a full-service CRO, and Veridix AI, our technology, data, and analytical solutions—we are modernizing clinical trials and accelerating the development of life-changing therapies. We believe that every clinical breakthrough starts with people—people who are passionate, purpose-driven, and ready to make an impact. Our culture is built on integrity, collaboration, and innovation, ensuring that every challenge is met with perseverance and accountability.

Role Description The Data Engineer will have a strong background in data engineering and extensive experience with AWS Cloud services. As a Data Engineer, they are responsible for designing, building, and maintaining scalable data pipelines and infrastructure to support our data analytics and business intelligence initiatives. - Design, develop, and maintain robust data pipelines and ETL processes to ingest, transform, and store data from various sources. - Collaborate with data scientists, analysts, and other stakeholders to understand data requirements, design data models, and deliver solutions that meet business needs. - Automate data workflows and implement monitoring and logging to ensure the health and performance of the data infrastructure. - Conduct data profiling, cleansing, and validation to ensure high data quality standards. - Optimize data storage and retrieval performance, ensuring data quality and integrity. - Implement and manage data architecture on AWS, ensuring scalability, reliability, and security. - Stay up to date with the latest trends and best practices in data engineering and AWS cloud technologies. Qualifications - Bachelor’s or master’s degree in computer science, Information Technology, or a related field. - 3 or more years of related professional experience. - Experience in data engineering with a strong focus on AWS cloud services. - Proficiency in SQL and experience with relational databases (e.g., PostgreSQL, MySQL, Redshift). - Experience with AWS services such as S3, Lambda, Glue, EMR, Kinesis, and Redshift. - Strong programming skills in languages such as Python, Java, or Scala. - Knowledge of data modeling, ETL concepts, and data warehousing. - Familiarity with version control systems (e.g., Git) and CI/CD pipelines. - Excellent problem-solving skills and attention to detail. - Knowledge of machine learning frameworks and data science workflows. - Familiarity with data visualization tools (e.g., QuickSight, Qlik). - Familiarity with NoSQL databases (e.g., DynamoDB, MongoDB). - Strong collaboration skills with cross-functional teams to establish best design and user flows for applications. - Strong multitasking, problem solving, and organizational skills. - Proven ability to work independently and in a team environment. - Satisfactory background check required. Benefits - Flexible Approved Time Off - Tuition Reimbursement - 401k Retirement Plan - Work From Home Anywhere in the US - Maternal/Paternal Leave - Casual Dress Code & Work Environment

Role Description The Events & Demand Generation Lead will manage Emmes Group’s presence at industry conferences and trade shows, and help to convert those touchpoints into commercial opportunities. This is a hands-on builder role that combines event ownership, inside sales, and pipeline generation to enhance brand visibility and build relationships with biopharma sponsors and partners. The primary focus of this role is to support The Emmes Group’s commercial and marketing initiatives through events and lead generation. Responsibilities - Event Management & Operations - Lead the end-to-end planning, coordination, and execution of conferences and trade shows ensuring each event aligns with organizational goals and delivers measurable impact. - Manage all event logistics, including booth design and setup, travel, accommodations, registration, collateral, and A/V requirements, while maintaining budget accountability. - Serve as the on-site event lead. - Collaborate across internal teams to ensure consistent messaging, brand alignment, and strategic objectives are achieved at every event. - Track event performance and provide post-event reporting, including attendance metrics, attendee engagement, leads generated, and overall event ROI, driving continuous improvement for future initiatives. - Inside Sales & Pipeline Development - Support pre-event engagement by identifying and prioritizing key prospects, coordinating outreach campaigns, and scheduling high-value meetings. - Qualify leads during events and ensure timely follow-up, maintaining accurate records in the CRM and contributing to pipeline growth. - Partner with Sales and Marketing teams to share insights, refine targeting and messaging strategies, and optimize event-driven opportunities. Qualifications - Bachelor's degree in business, Marketing, Life Sciences, or related field. - 3–5 years of experience managing industry conferences and trade shows, preferably in clinical research, life sciences, or healthcare technology. - Proven inside sales or business development experience in a CRO (Contract Research Organization), CDMO (Contract Development and Manufacturing Organization), clinical technology, or life sciences services organization strongly preferred. - Experience engaging biopharma sponsors or clinical development, medical, or R&D leaders, ideally within oncology, vaccines, infectious disease, ophthalmology, neurology, or rare diseases, is highly desirable. - Excellent communication, networking, and relationship-building skills with scientific and professional audiences. - Strong project management skills and ability to manage multiple events and sales initiatives simultaneously. - Comfortable standing at the booth, actively initiating conversations, and representing Emmes during busy conference days. - Experience with CRM systems, event management tools, and Microsoft Office Suite. - Willingness to travel extensively to support conferences and events. - Knowledge of clinical research, the biopharma sponsor landscape, and/or AI-enabled clinical solutions is a plus. Benefits - Flexible Approved Time Off - Tuition Reimbursement - 401k Retirement Plan - Work From Home Anywhere in the US - Maternal/Paternal Leave - Casual Dress Code & Work Environment

Role Description The Associate Director, Clinical Applications will provide strategic and technical leadership for the design, implementation, optimization, and support of clinical application ecosystems. This role partners closely with business stakeholders, IT leadership, and vendors to ensure clinical applications platforms effectively support business operations, regulatory compliance, and organizational growth. The Associate Director will lead application teams, drive modernization initiatives, and ensure reliable, secure, and scalable clinical systems across the organization. - Provide leadership and strategic direction for clinical applications, including CTMS, eTMF, Safety, Payments, QMS, LMS, and more. - Partner with business leaders to understand operational needs and translate them into application roadmaps and technology solutions. - Oversee the full application lifecycle: planning, design, implementation, integration, upgrades, maintenance, and retirement. - Lead and mentor application support and development teams; manage performance, priorities, and professional growth. - Drive continuous improvement, automation, and modernization initiatives to enhance system performance and user experience. - Manage vendor relationships, contracts, and service-level agreements to ensure quality delivery and cost efficiency. - Ensure clinical applications meet security, compliance, validation, and data governance requirements (including GxP, SOC, GDPR/HIPAA as applicable). - Collaborate with infrastructure, security, data, and architecture teams to ensure integrated, scalable solutions. - Develop and manage budgets, timelines, and resource plans for clinical application initiatives. - Establish and maintain documentation, standard operating procedures, and governance frameworks. - Monitor system performance, availability, and incident trends; lead root cause analysis and remediation efforts. - Perform other duties as assigned. - Comply with all policies and standards. Qualifications - Bachelor's Degree in Computer Science, Information Systems, Biology, Public Health, or related field - Required - Master's Degree in Computer Science, Information Systems, Biology, Public Health, or related field - Preferred - Relevant certifications (e.g., Veeva) - Preferred - 8 years of progressive experience in clinical operations and/or systems management/leadership - Required - 3 years of experience in people leadership or managing technical teams, inclusive of overall experience - Required - Demonstrated experience leading clinical application implementations, upgrades, and large-scale transformation initiatives - Required - Experience working in regulated environments such as life sciences, healthcare, clinical research, or highly compliant industries - Preferred - Proven experience managing third-party vendors, consultants, and implementation partners - Preferred - Experience supporting multi-system integrations and complex application landscapes - Preferred - Strong knowledge of clinical application platforms (e.g., CTMS, eTMF, Safety, Payments, QMS, LMS, and workflow automation tools) - High - Solid understanding of system integration patterns, APIs, middleware, and data flows - High - Working knowledge of IT governance, application lifecycle management, validation, security, and compliance standards - High - Excellent leadership and people management skills with the ability to motivate and develop high-performing teams - High - Strong business acumen with the ability to align technology solutions to organizational goals - High - Excellent communication and stakeholder management skills; ability to engage effectively with executive leadership and technical teams - High - Proven ability to manage complex projects, prioritize competing demands, and deliver results in a fast-paced environment. - Strong analytical, problem-solving, and decision-making capabilities. - Ability to influence change, drive adoption, and manage organizational change related to new systems and processes. Benefits - Advancing global health and scientific excellence. - Opportunity to be part of something bigger.

Role Description Essex Management is seeking Business Systems Engineers at multiple levels to support process modernization and business transformation initiatives within Life Sciences and Clinical Informatics programs. These roles apply process improvement and business process reengineering methodologies to enhance organizational performance, operational efficiency, and adoption of technology-enabled solutions within regulated federal health IT environments. Depending on experience and qualifications, selected candidates may be considered for multiple openings at either the Business Systems Engineer I or Business Systems Engineer II level. Responsibilities may range from supporting senior staff on modernization initiatives to independently leading process transformation efforts and mentoring junior team members. Responsibilities - Apply process improvement and business process reengineering (BPR) methodologies to support modernization initiatives - Analyze and document current-state (as-is) processes and assist in designing future-state (to-be) workflows across clinical informatics functional areas - Support or lead activity modeling, data modeling, and workflow analysis to identify inefficiencies and improvement opportunities - Assist with or lead the transition of project teams to improved, automated, and technology-enabled business processes - Contribute to the development and implementation of modern business methods and digital process enhancements - Identify, document, and promote best practices across functional areas within client portfolios - Define, track, and assess performance metrics and key performance indicators (KPIs) to measure process effectiveness and mission impact - Facilitate stakeholder interviews, workshops, and group sessions to gather requirements and build engagement - Support training efforts, knowledge transfer activities, and user documentation development for deployed solutions - Collaborate with cross-functional teams — including IT, quality management, and program management staff — to align business needs with technical solutions - Contribute to requirements elicitation, use case development, testing activities, and user acceptance testing (UAT) - Develop and maintain process documentation, reports, repositories, and analysis artifacts to support knowledge management initiatives - Provide recommendations to improve data quality, system integration, and operational performance - For more senior-level roles, provide task-level oversight, mentoring, and guidance to junior staff members Qualifications - Bachelor’s degree in Health Informatics, Business Administration, Information Systems, Information Technology, or a related field required (or commensurate education and experience) - Relevant experience in business process improvement, business analysis, systems engineering, or related disciplines - Business Systems Engineer I: Typically requires 2+ years of relevant experience - Business Systems Engineer II: Typically requires 4–7 years of relevant experience - Experience may include internships, graduate research assistantships, co-ops, or professional experience in relevant environments - Exposure to one or more of the following is preferred: - Pharmaceutical or biopharmaceutical research operations - GxP environments - 21 CFR Part 11 compliance requirements - Federal health IT systems - Clinical research coordination - Demonstrated experience working in IT and data-driven environments supporting system interoperability, implementations, change management, and business process redesign Requirements - Knowledge of process improvement methodologies such as Lean, Six Sigma, or Business Process Reengineering - Experience with process modeling, workflow documentation, and data analysis techniques - Strong analytical, problem-solving, and organizational skills - Exposure to workflow automation tools, digital transformation concepts, or internet-based systems is a plus - Familiarity with software development lifecycle (SDLC) concepts and Agile methodologies is preferred Core Competencies - Strong communication, facilitation, and stakeholder engagement skills across technical and non-technical teams - Ability to collaborate effectively in a team-oriented, fast-paced consulting environment - Experience supporting organizational change management and modernization initiatives - Ability to support or lead meetings, workshops, interviews, and training activities - Experience with performance measurement and KPI development is desirable - For senior-level candidates, ability to provide mentoring, guidance, and task oversight to junior staff Preferred Qualifications - Desirable certifications include: - PMP (PMI) - Lean Six Sigma Green or Black Belt - CISA (ISACA) - HL7 FHIR - CPHIMS (HIMSS) - Familiarity with clinical research regulatory frameworks (e.g., GxP guidelines, 21 CFR Part 11, GAMP 5) is a plus - Experience supporting or working on projects associated with federal health agencies such as NIH, NCI etc. is highly desirable Benefits - Flexible Approved Time Off - Tuition Reimbursement - 401k Retirement Plan - Work From Home Anywhere in the US - Maternal/Paternal Leave - Casual Dress Code & Work Environment

Role Description The Business Systems Architect II provides strategic leadership and oversight for enterprise-wide process modernization initiatives within Life Sciences and Clinical Informatics programs. This role manages the application of advanced process improvement and reengineering methodologies to transform organizational operations, ensuring alignment with client goals and objectives through the effective integration of business architecture, digital enablement, and stakeholder engagement disciplines. Serving as the primary coordinator between client delivery and project teams, the Business Systems Architect II ensures integrated, scalable, and best practice-driven solutions across the enterprise. - Lead and manage large-scale business process reengineering (BPR) and modernization initiatives across enterprise portfolios. - Oversee the application of process improvement methodologies and digital strategies to enhance organizational performance. - Direct the assessment of current-state (as-is) processes and the design and implementation of optimized future-state (to-be) solutions. - Serve as primary coordinator between client delivery and project teams to ensure enterprise-wide integration and alignment. - Drive the transition of organizations and project teams to improved, automated, and technology-enabled processes. - Promote and ensure adoption of best practices, including e-business strategies and digital transformation approaches. - Oversee activity modeling, data modeling, and workflow optimization to support scalable and efficient operations. - Establish, monitor, and evaluate performance metrics and KPIs to measure process effectiveness and mission impact. - Lead stakeholder engagement efforts, including executive briefings, workshops, and cross-functional collaboration sessions. - Direct training, knowledge transfer, and change management initiatives to support successful adoption of new processes and systems. - Provide strategic recommendations to improve system integration, data quality, and operational efficiency. - Supervise and provide direction to business systems engineering and architecture staff, and other project team members as appropriate. - Ensure comprehensive documentation, governance, and continuous improvement of business processes across client and internal organizations. - Lead Analysis of Alternatives and market research assessments to inform COTS selection and solution design decisions. - Collaborate with program management, quality management, and engineering to ensure product delivery aligns with client SDLC methodologies and GAMP 5 frameworks. Qualifications - Bachelor's degree in Business Administration, Information Systems, Health Informatics, or a related field; Master's degree preferred (or commensurate education and experience). - 7+ years of experience in business process reengineering, process improvement, enterprise analysis, or related roles. - Experience with one or more of the following: pharmaceutical, clinical research or biopharmaceutical research operations, GxP environments, federal health IT systems. - Familiarity with clinical research regulatory frameworks including GxP guidelines, 21 CFR Part 11, and GAMP 5 is required at this level. - Demonstrated experience working in IT and data-driven environments supporting system interoperability, implementations, change management, and business process redesign. Requirements - Demonstrated ability to develop and communicate business capability models, value stream maps, and conceptual data models that inform solution design and investment decisions. - Proficiency with enterprise architecture frameworks and modeling standards, including TOGAF and ArchiMate, applied to business and information architecture layers. - Proficiency with process modeling notations and tools, including BPMN and related diagramming platforms (e.g., Visio, iServer, Sparx EA, or equivalent). - Ability to analyze organizational capabilities, identify gaps and redundancies, and develop actionable capability roadmaps aligned to mission objectives. - Experience conducting business-architecture-informed Analysis of Alternatives (AoA) and market research to support COTS evaluation and selection. - Ability to bridge business and technical domains — translating strategic intent into functional requirements, system design inputs, and implementation guidance. - Experience supporting or leading enterprise-level change management initiatives grounded in business architecture analysis. - Familiarity with federal health IT architectural standards and frameworks (e.g., HHS EPLC, NIST, FISMA) as they apply to clinical informatics environments. Core Competencies - Demonstrated leadership in managing enterprise-level process transformation and modernization initiatives. - Deep expertise in process improvement methodologies (e.g., Lean, Six Sigma, Business Process Reengineering). - Strong experience with enterprise process modeling, data analysis, and workflow optimization. - Proven ability to lead cross-functional teams and coordinate efforts across multiple projects and stakeholders. - Experience driving digital transformation initiatives, including the use of internet-based technologies and automation tools. - Strong facilitation, communication, and executive-level stakeholder engagement skills. - Experience establishing and evaluating performance metrics and KPIs at an organizational level. - Demonstrated ability to mentor, supervise, and develop junior and mid-level business systems engineering and architecture staff. - Strong strategic thinking and problem-solving capabilities with a focus on scalable, enterprise-grade solutions. Preferred Qualifications - Desirable certifications: TOGAF 9/10 (Open Group), Zachman Framework Certification, Certified Business Analysis Professional, IIBA (CBAP), Project Management Professional (PMP), Lean Six Sigma Green or Black Belt, CISA (ISACA), HL7 FHIR, CPHIMS (HIMSS). - Experience supporting or working on projects associated with federal health agencies such as National Institutes of Health (NIH), National Cancer Institute (NCI) etc. is highly desirable. Benefits - Flexible Approved Time Off. - Tuition Reimbursement. - 401k Retirement Plan. - Work From Home Anywhere in the US. - Maternal/Paternal Leave. - Casual Dress Code & Work Environment.

Role Description Provide day-to-day IT support for end-users including troubleshooting hardware, software, and network issues. - Assist in user account creation, access management, and system administration tasks on a regular basis. - Support enterprise applications (SharePoint, ERP, CRM, collaboration tools, etc.) by documenting processes, troubleshooting issues, and coordinating with vendors as needed. - Participate in IT security activities including patch management, endpoint protection, and access reviews. - Monitor IT infrastructure performance (Data Center and Cloud – AWS/Azure) and escalate issues when required. - Contribute to IT documentation, knowledge base creation, and process improvement initiatives. - Collaborate with global IT teams to ensure adherence to governance and compliance standards. Qualifications - B.E / B. Tech in Computer Science, Electronics & Communication, or Information Technology or equivalent. Company Description Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience. We believe the work we do will have a direct impact on patients’ lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We’re looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Role Description The Software Development Engineer Intern (AWS & Systems Focus) assists in the design, development, and maintenance of scalable backend and data-driven systems that support clinical trials and enterprise analytics platforms. Working under the guidance of senior engineers, the intern will contribute to cloud-native services, data processing components, and system integrations on AWS. This role emphasizes software engineering fundamentals, backend development, and system design, providing hands-on experience with real-world distributed systems. - Assist in building and maintaining backend services and system components using Go, Rust, TypeScript, Python, or Node.js. - Participate in designing and implementing scalable, reliable system architectures. - Perform data validation, cleansing, and basic data quality checks. - Write unit tests and support debugging and performance analysis of backend systems. - Help document system designs, data flows, and technical decisions. - Collaborate with software engineers, data engineers, and stakeholders to understand requirements and deliver solutions. - Follow software engineering best practices including security, reliability, and compliance standards. Qualifications - Currently pursuing a Bachelor’s or Master’s degree in Computer Science, Data Science, Engineering, Information Systems, Mathematics, or a related field. - Familiarity with Go, Rust, TypeScript, Python, or Node.js. - Basic understanding of data structures, algorithms, and software engineering concepts. - Basic understanding of cloud computing concepts, preferably AWS. - Ability to work collaboratively in a fast-paced engineering environment. - Attention to detail and ability to work with large datasets. - Good communication skills and ability to work collaboratively in a team environment. - Eagerness to learn backend systems, cloud platforms, and distributed systems. Benefits - Flexible Approved Time Off - Tuition Reimbursement - 401k Retirement Plan - Work From Home Anywhere in the US - Maternal/Paternal Leave - Casual Dress Code & Work Environment