Emmes Group

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

Role Description The Project Leader - Biostatistician (PL-Stat) is critical to the successful conduct of government-sponsored clinical research projects, serving as the matrix leader of the core project team. In addition to serving as study Biostatistician, the PL-Stat is accountable for successful delivery of clients' statement of work activities within timeline and budget. The PL-Stat develops and maintains a positive relationship with clients and other external stakeholders, oversees deliverable quality, mentors staff, and works collaboratively across departments to accomplish project goals. The PL-Stat is responsible for the continuous monitoring, identification, escalation and mitigation of project risk. - Accountable for technical, scientific, and fiscal execution of government research projects through collaboration with staff from multiple departments. - Perform statistical duties per statistical JDs level/experience and project SOW. - Sets priorities for the project team, ensures quality processes are followed, and collaboratively establishes and maintains deliverable timelines. - Identifies statistical issues, proposes solutions, and consults with other statisticians across the company on project-related statistical matters. - Serves as the primary point of contact for clients, investigators, and other stakeholders for assigned projects and/or protocols. - Develops, reviews, and approves project plans, study documents, and processes/SOPs, as needed. - Applies broad knowledge of therapeutic areas, clinical trial design, and process expertise to influence and execute project decisions. - Defines and approves approaches or solutions to project requirements, risks, and issues. - Develops, maintains, and secures approval of budgets, statements of work, and subsequent modifications prior to client distribution. - Liaises with corporate leaders and other departments to ensure staff resources are informed, trained, and efficiently utilized. - Represents the project in Corporate meetings and provides central status reporting and information to Executive leadership. - Uses key performance metrics to effectively execute the project scope. - Mentors project staff and supports staff development; may contribute to the development of new Project Leaders. - Supports corporate knowledge expansion by participating in internal and external meetings/trainings. - Promotes and implements corporate initiatives, as directed. - Leads or contributes to operational strategy development, budget preparation, and proposal content for new business opportunities. - Performs other duties as assigned. - Complies with all policies and standards. Qualifications - 6 years + Master's or 3 years + PhD of empirical knowledge of the key accountabilities/duties/responsibilities for the position. - Demonstrated working knowledge of the principles of clinical trial management and operations. - Project Delivery Track Record: Demonstratable track record of successfully delivering complex/high-priority clinical trials or clinical research projects. - Clinical Research Knowledge: Demonstrated working knowledge of the principles of clinical research management and operations. - Problem-Solving: Demonstrated strong problem-solving and analytical skills. - Communication: Excellent verbal and written communication skills for client, team, and scientific interactions. - Leadership & Teamwork: Ability to work proactively and effectively, with creative problem-solving and collaboration skills. - Project Management: Strong cross-functional project management and time management skills. - Therapeutic Expertise (Preferred): Broad understanding of a therapeutic area, clinical trial design, and/or process expertise. 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 Marketing Specialist will be responsible for the execution of campaign activities across multiple channels, ensuring initiatives are delivered on time and in line with business objectives. This role will track, analyze, and report on campaign performance, providing insights and recommendations to commercial leaders to support data-driven decision making. The Marketing Coordinator will work closely with the wider marketing team, ensuring smooth coordination and alignment of activities that drive commercial impact and deliver measurable results. We are seeking an individual contributor. This is a role focused on primarily executing digital product launches. The campaign(s) already have a strategy in place. We're seeking someone who is comfortable in supporting digital marketing campaigns for software products and solutions. And you have worked for a pharmaceutical, biotechnology or software company that caters to the BioPharma space, that will work well just in case you haven't worked for a Contract Research Organization (CRO) like us. Responsibilities - Help coordinate and execute marketing campaigns and product launches across digital and traditional channels, ensuring timely delivery and alignment with commercial priorities. - Monitor and track campaign progress, adjusting activities as needed to optimize performance and impact. - Analyze campaign and product launch results and prepare regular performance reports with clear insights, trends, and recommendations for commercial leaders. - Collaborate with product and commercial teams to ensure marketing activities support revenue goals and market priorities. - Manage campaign calendars, timelines, and budgets to ensure efficient resource allocation and execution. - Support the wider marketing team in the development of campaign assets and go-to-market activities across the Emmes Group. - Ensure consistent brand representation and messaging across all marketing campaigns and touchpoints. - Identify opportunities to improve campaign effectiveness through testing, data analysis, and best practice sharing. - Serve as the key liaison for campaign reporting, presenting results and learnings to stakeholders in a clear and actionable way. Qualifications - Bachelor’s degree in marketing, Public Relations or in a related field required. - 3+ years’ experience in a related sales or marketing role, preferably within a global health, clinical research, biotechnology, or life sciences environment preferred. - Advanced proficiency in Microsoft Office Suite including Word, Excel, PowerPoint, Outlook, SharePoint. - Understanding of marketing automation software such as Hubspot, or Marketo. - Excellent written and verbal communication skills. - Knowledge and understanding of scientific and research terminology in written communication materials desired. - Proven experience in project and lead management. - Ability to manage multiple projects at once with strong analytical, organizational, and creative thinking skills. - Understanding and familiarity with industry related conferences and workshops. 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 Director of Business Development is responsible for driving net-new revenue growth for Emmes by identifying, developing, and closing strategic clinical research opportunities across the company's core specialties, including Hematology and Oncology, Ophthalmology, and Vaccines and Infectious Disease. This is a high-impact, externally facing commercial role for a proven hunter who can open doors, create opportunities before a formal procurement process begins, and position Emmes as a strategic partner early in sponsors' development planning. The role requires a business development leader who is highly proactive, commercially aggressive, relationship-driven, and comfortable navigating long, complex sales cycles in biotech and pharma. Responsibilities - Drive net-new business development by securing new sponsor relationships and expanding Emmes' presence in targeted biotech and pharmaceutical accounts. - Build and manage a high-quality pipeline of qualified opportunities, with strong emphasis on identifying programs before formal RFP issuance and before CRO shortlists are finalized. - Develop and execute territory, account, and opportunity strategies that increase early access to sponsor clinical development discussions, including protocol planning, study design, operational strategy, and vendor evaluation. - Leverage existing relationships, market intelligence, conference activity, and industry networks to uncover emerging clinical programs and create opportunities well in advance of procurement events. - Differentiate Emmes' capabilities in scientific partnership, operational delivery, digital and AI-enabled CRO services, and therapeutic depth to win competitive opportunities. - Meet or exceed annual sales goals for new-logo revenue, total signed awards, and qualified pipeline generation. - Serve as a strategic commercial leader in Emmes' core therapeutic areas, with broad familiarity across the portfolio and recognized subject-matter depth in Hematology and Oncology. - Partner closely with therapeutic area, operational, and executive leadership teams to shape compelling win strategies and customer-specific solutions. - Lead client meetings, capability presentations, strategic account reviews, and bid defense activities to advance and close new business opportunities. - Maintain disciplined CRM hygiene, opportunity tracking, competitive intelligence reporting, and account planning to support forecasting accuracy and commercial execution. - Monitor competitor activity, awarded studies, and sponsor buying patterns to reduce missed opportunities and improve Emmes' ability to engage earlier in the decision cycle. - Perform other duties as needed to support Emmes' broader growth strategy. Qualifications - Bachelor's degree required in a scientific, clinical, healthcare, or business discipline; advanced degree preferred. - Minimum 5 years of business development experience, with substantial direct experience selling CRO services to biotech and/or pharmaceutical sponsors. - Prior CRO industry experience is required. - Demonstrated track record of winning new business, opening new accounts, and expanding commercial relationships in complex, consultative sales environments. - Experience engaging sponsor decision-makers at the C-suite levels across clinical development, clinical operations, procurement, and executive leadership. - Strong understanding of the clinical development lifecycle and how CROs are engaged before, during, and after formal sourcing processes. - Demonstrated success in the Hematology and Oncology therapeutic area. - Proven ability to identify, qualify, shape, and close complex CRO opportunities with long sales cycles and multiple stakeholders. - Strong network across biotech and pharma with the ability to convert relationships into early commercial access. - Ability to discuss study objectives, trial design considerations, operational models, and sponsor priorities in a commercially credible and scientifically informed manner. - Strong presentation, proposal strategy, negotiation, and interpersonal skills. - High level of discipline in CRM usage, pipeline management, forecasting, and opportunity planning. - Strong command of Microsoft Office and CRM platforms. - Ability to travel up to 50% to sponsor, industry, and corporate locations. 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 Oversees statistical activities and deliverables across a broad research area. Provides guidance and oversight to other senior statistical staff and ensures timely and high-quality completion of statistical activities. Responsibilities - Manages a team of Biostatistician Managers and is responsible for statistical deliverables across a broad research area. - Serves as a client point of contact for statistical deliverables on large projects, fostering a collaborative relationship with contract sponsors and Emmes project team members. - Manages statistical resources (i.e. budget and personnel) across a broad research area to ensure statistical tasks are completed on schedule and that each project has adequate staffing levels. - Develops strategic vision for the department in collaboration with the Director of Biostatistics. - Serves as the identified internal point of contact for other corporate and senior project staff for management of budgeting, staffing, and statistical activities. - Participates in recruiting activities for new statistical staff members and makes hiring decisions. - Serves as a statistical expert and provides consultation to projects across the company. - Supervises and mentors senior statistical staff, promotes career development and growth for senior staff. - Represents Emmes at Sponsor, Regulatory, Investigator or Safety Review meetings (e.g., Data and Safety Monitoring Board Meetings). - Establishes budgets for statistical activities on new project work. - Identifies statistical and operational issues and proposes solutions. - Prepares, reviews and/or approves clinical project material that requires statistical input to ensure that the documents are scientifically valid and feasible. - Reviews work processes, schedules and checklists to ensure that all routine activities, as documented in corporate and project specific Standard Operating Procedures (SOPs), are efficiently performed. - Participates in project and corporate quality assurance activities, particularly those of a statistical nature. - Ensures that project staff is trained and mentored, supervises project staff and performs personnel reviews. - Provides project updates to Director of Biostatistics. - Performs other duties as assigned. - Complies with all policies and standards. Qualifications - Master's or PhD in Statistics, biostatistics, epidemiology or related field. - 7 (with PhD) or 10 (with MS) years of related experience; including leading a clinical research team and supervising senior level statistical staff. - Expertise in state of the art data manipulation and statistical analyses. - Proven effective leadership of a clinical research team. - Strong skills in prioritization, problem solving, organization, decision making, time management, negotiation, mentoring and planning. - Self-motivated, proactive and detail oriented. - Demonstrated ability to manage multiple tasks, while working independently. - Ability to effectively communicate technical concepts, both written and oral. 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 Clinical Project Manager (CPM) II is responsible for delivering clinical and research initiatives that support complex IT and life sciences programs. This role leads cross-functional project teams across technology implementations, clinical study operations, data integrations, and regulatory-compliant systems. The CPM II brings hands-on study management experience spanning participant enrollment, informed consent, data collection, and research participant engagement — ensuring that operational execution aligns with both scientific objectives and compliance requirements. The CPM II cultivates collaborative relationships with project and client stakeholders, coordinating across teams to ensure study goals are achieved and deliverable timelines are met. This role drives implementation strategy, maintains operational plans and documentation, and continuously optimizes study processes to support high-quality clinical research delivery. The CPM II is expected to maintain current awareness of industry best practices and emerging trends in study management, actively contributing that knowledge to strengthen Essex's methodologies and commitment to continuous improvement. Qualifications - Bachelor's degree in public health, life sciences, clinical research, or a related field (Master's preferred); or a commensurate combination of education and experience - 3–5+ years of experience in clinical research operations, study implementation, clinical data management, or a related discipline - Familiarity with IRB processes, regulatory requirements, and clinical research compliance standards - Experience with oncology and/or rare disease studies is desirable Requirements - Lead the end-to-end execution of clinical trials and observational studies, from protocol design through final clinical study report, applying best practices across all project phases — initiation, planning, execution, monitoring, and close-out - Develop and maintain integrated, cross-functional project plans to support study tracking, milestone management, and oversight across all workstreams - Anticipate potential barriers, identify project risks, and propose mitigation strategies; adhere to established governance structures and processes for assigned projects - Lead and coordinate cross-functional study team activities, including patient engagement, clinical monitoring, data management, biostatistics, and safety, to ensure proper conduct and timely study completion - Collaborate with internal teams, contractors, and vendors — including functions such as finance, R&D, regulatory, and marketing — to align efforts and achieve study goals and objectives - Ensure communication plans are in place and maintained to support effective information flow among all study and project stakeholders - Contribute to database design and development with a focus on data abstraction, report generation, and quality assurance to support effective data monitoring - Maintain compliance with Good Clinical Practice (GCP), regulatory requirements, and applicable Essex and client policies and procedures - Participate in quality assurance activities to ensure deliverables meet contractual requirements and key performance indicators are monitored and achieved - Track and manage adherence to budget, scope, and schedule requirements throughout the project lifecycle - Organize and facilitate project meetings, including scheduling, preparation of materials, meeting minutes, and follow-up on action items - Prepare monthly status reports and project-specific documentation in accordance with reporting requirements - Complete required Essex and client training and maintain ongoing awareness of relevant policies to ensure continuous compliance 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 Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. 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! Qualifications - Relevant experience in clinical research. - Strong communication and collaboration skills. - Ability to work in a fast-paced environment. - Passion for advancing medical research. Requirements - Experience with clinical trials and regulatory processes. - Proficiency in data analysis and interpretation. - Strong organizational skills and attention to detail. Benefits - Competitive salary and performance-based bonuses. - Comprehensive health benefits. - Flexible working hours and remote work options. - Opportunities for professional development and growth. Company Description 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 - Neuroscience