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The Emmes Company LLC
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  • Overview US Remote Emmes Group: Building a better future for us all. E... Read More
    Overview US Remote Emmes Group: Building a better future for us all. 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! Primary Purpose Accountable for successful delivery of clients' statement of work within budget on clinical research projects, maintains a positive relationship with clients, supervises project leaders, mentors staff, and works collaboratively with Business Development to help generate new business. Responsibilities Accountable for technical, scientific, fiscal, and overseeing of research projects working with staff from other verticals at Emmes responsible for research support activities, including but not limited to Clinical Operations, Statistical and Scientific Innovation, Regulatory Affairs, and Pharmacovigilance. Proactively assesses client expectations and addresses client's needs for ongoing studies/support and engages with clients for new opportunities in support of future studies. Reviews, provides input on, and approves project and study documents and processes, as needed. Represents the project or company at client meetings and scientific conferences. Utilizes broad understanding of therapeutic, clinical trial design, and/or process expertise to influence and executes project decisions considering client needs, budget considerations and the current state of the research field. Defines solutions with input from team members that will be implemented to meet client's needs that address contractual aspects of projects (e.g., project contracts, scope of work, budgets, subcontracts, vendor agreements) to ensure delivery of high-quality contract deliverables. Defines solutions with input from team members that will be implemented to mitigate risk and communicate risks and contingencies with clients. Approves initial budgets and statement of work documents and subsequent modifications before distribution to clients. Liaises with corporate services and leaders from other Emmes verticals and departments to ensure staff resources are adequate within the project team to successfully meet the client's requirements. Participates in project review meetings with TRU Directors and/or TRU Oversight, and Commercial and Service Project Oversight, if applicable. Uses established key performance metrics to assure successful delivery of the project that meet client requirements. Supervises, mentors, and supports lower level project leaders (if applicable) to ensure they are properly trained for their current positions and have growth and development opportunities. Mentors project staff from other verticals pursuing a Project Leader role within the Therapeutic and Research Units. Participates in relevant corporate meetings and provides information learned and best practices to project team as applicable. Implements relevant corporate initiatives directed towards Project Leaders and therapeutic research areas, taking into account project budget considerations. Provides support to the Chief Business Officer as a subject matter expert in a therapeutic or research area and discusses business opportunities with clients and study collaborators, as appropriate. Contributes to the development of operational strategy, budget, and proposal content for new business opportunities. Qualifications Education/Requirements Project Leader: Bachelor's degree, preferably in a scientific discipline, with at least 8 years of experience within pharma and/or CRO; Master's degree with at least 6 years of experience within pharma and/or CRO; PhD with at least 3 years of experience within pharma and/or CRO Demonstrated working knowledge of the principles of clinical trial management and operations with at least 3 years of management experience in a research environment Prior CRO/clinical trial management of late-stage clinical trials preferred Demonstrable track record of success delivering complex/high-priority clinical trials within the agreed time, quality, and cost Demonstrated strong problem solving and analytical skills, combined with sound business judgment Ability to work proactively and effectively, with creative problem-solving and collaboration skills Highly motivated with ability to work independently and as part of a multi-disciplinary team Strong cross-functional project management and time management skills Excellent verbal and written communication skills Experience in therapeutic research areas that will align with Emmes' expertise, including substance use and mental health is strongly preferred Why work at Emmes? At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including: Flexible Approved Time Off Tuition Reimbursement 401k Retirement Plan Work From Home Anywhere in the US Maternal/Paternal Leave Casual Dress Code Read Less
  • Associate Project Leader  

    - Montgomery County
    Overview Associate Project Leader US Remote Emmes Group: Building a be... Read More
    Overview Associate Project Leader US Remote Emmes Group: Building a better future for us all. 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! Primary Purpose Accountable for successful delivery of clients' statement of work within budget on clinical research projects, maintains a positive relationship with clients, supervises project leaders, mentors staff, and works collaboratively with Business Development to help generate new business. Responsibilities Accountable for technical, scientific, fiscal, and overseeing of research projects working with staff from other verticals at Emmes responsible for research support activities, including but not limited to Clinical Operations, Statistical and Scientific Innovation, Regulatory Affairs, and Pharmacovigilance. Proactively assesses client expectations and addresses client's needs for ongoing studies/support and engages with clients for new opportunities in support of future studies. Reviews, provides input on, and approves project and study documents and processes, as needed. Represents the project or company at client meetings and scientific conferences. Utilizes broad understanding of therapeutic, clinical trial design, and/or process expertise to influence and executes project decisions considering client needs, budget considerations and the current state of the research field. Defines solutions with input from team members that will be implemented to meet client's needs that address contractual aspects of projects (e.g., project contracts, scope of work, budgets, subcontracts, vendor agreements) to ensure delivery of high-quality contract deliverables. Defines solutions with input from team members that will be implemented to mitigate risk and communicate risks and contingencies with clients. Approves initial budgets and statement of work documents and subsequent modifications before distribution to clients. Liaises with corporate services and leaders from other Emmes verticals and departments to ensure staff resources are adequate within the project team to successfully meet the client's requirements. Participates in project review meetings with TRU Directors and/or TRU Oversight, and Commercial and Service Project Oversight, if applicable. Uses established key performance metrics to assure successful delivery of the project that meet client requirements. Supervises, mentors, and supports lower-level project leaders (if applicable) to ensure they are properly trained for their current positions and have growth and development opportunities. Mentors project staff from other verticals pursuing a Project Leader role within the Therapeutic and Research Units. Participates in relevant corporate meetings and provides information learned and best practices to project team as applicable. Implements relevant corporate initiatives directed towards Project Leaders and therapeutic research areas, taking into account project budget considerations. Provides support to the Chief Business Officer as a subject matter expert in a therapeutic or research area and discusses business opportunities with clients and study collaborators, as appropriate. Contributes to the development of operational strategy, budget, and proposal content for new business opportunities. Qualifications Education/Requirements Associate Project Leader: -Bachelor's degree, preferably in a scientific discipline, with at least 6 years of experience within pharma and/or CRO; -Master's degree with at least 4 years of experience within pharma and/or CRO; -PhD with at least 1 years of experience within pharma and/or CRO Demonstrated working knowledge of the principles appropriate to the position with a typical tenure of at least 1 year management experience in a research environment. Prior CRO/clinical trial management of late-stage clinical trials preferred Demonstrable track record of success delivering complex/high-priority clinical trials within the agreed time, quality, and cost Demonstrated strong problem solving and analytical skills, combined with sound business judgment Ability to work proactively and effectively, with creative problem-solving and collaboration skills Highly motivated with ability to work independently and as part of a multi-disciplinary team Strong cross-functional project management and time management skills Excellent verbal and written communication skills Experience in therapeutic research areas that will align with Emmes' expertise, including substance use and mental health is strongly preferred Why work at Emmes? At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including: Flexible Approved Time Off Tuition Reimbursement 401k Retirement Plan Work From Home Anywhere in the US Maternal/Paternal Leave Casual Dress Code Read Less
  • Overview Job Title: Manager, Reading Centre Operations - OptymEdge Loc... Read More
    Overview Job Title: Manager, Reading Centre Operations - OptymEdge Location: US - Remote OptymEdge, (part of the Emmes Group), develops proven solutions for training and certification of Visual Function Examiners and Visual Acuity Rooms. OptymEdge partners with study teams to provide visual function certification that ensures a high level of quality and consistency for ophthalmic clinical trial data. OptymEdge is the largest and longest-standing certification organization in the industry. We pioneered visual acuity certification from conception. Our services have grown to be synonymous with providing the highest level of quality and standardization of clinical trial data. Over 2,500 sites certified worldwide, since 1995 Phase I through post-marketing experience across anterior segment and retina trials Clinical Ophthalmology, Optometry, and clinical trial expertise Primary Purpose The Manager, Reading Centre Operations is a senior, cross-functional role responsible for integrating clinical operations, analytics, systems readiness, and quality oversight across Imaging Reading Center activities. Trained across multiple operational domains, this role provides flexible coverage, analytical leadership, and operational problem resolution across studies, while preserving formal accountability within established functional roles. This role is intentionally trained across multiple Imaging Reading Center functions and may temporarily perform, or support tasks assigned to other roles to ensure operational continuity and timely issue resolution. Formal approval authority and regulatory accountability remain with designated role owners. Responsibilities Generate study-level and cross-study operational analytics, KPIs, trend analyses, and recurring reports to support study oversight, quality monitoring, and sponsor and internal reporting. Translate Imaging Reading Center clinical and operational requirements into system requirements, user stories, and acceptance criteria, and execute user acceptance testing using dummy data and defined edge cases. Design and maintain operational trackers, reports, and dashboards supporting certification tracking, QC oversight, and consistency in study monitoring. Develop, refine and maintain program-level SOPs, work instructions, and operations manuals during Reading Center build-out and scaling phases. Design role-based training frameworks, onboarding materials, and core training content to support consistent competency development across Reading Centre roles. Support budget architecture, pricing logic, and proposal updates aligned with study scope, operational complexity, and resource requirements. Resolve cross-functional operational issues across PM, QC, grading, data management, and systems workflows prior to formal escalation. Support institutional knowledge transfer, role readiness, and operational continuity during Reading Center growth and scaling periods. Develop, refine and maintain program-level SOPs, work instructions, and operations manuals during Reading Center build-out and scaling phases. Design role-based training frameworks, onboarding materials, and core training content to support consistent competency development across Reading Centre roles. Support budget architecture, pricing logic, and proposal updates aligned with study scope, operational complexity, and resource requirements. Resolve cross-functional operational issues across PM, QC, grading, data management, and systems workflows prior to formal escalation. Support institutional knowledge transfer, role readiness, and operational continuity during Reading Center growth and scaling periods. Qualifications Master's Degree 7-9 years experience in clinical operations, imaging workflows, analytics, or regulated research environments. Demonstrated ability to translate operational needs into analytical, system, and process solutions. Strong analytical, communication, and cross-functional collaboration skills. Systems-level and integrative thinking Analytical rigor with operational pragmatism Strong judgment and prioritization across complex workflows Collaborative leadership and mentoring mindset Commitment to quality, inspection readiness, and continuous improvement Emmes Group: Building a better future for us all. OptymEdge is part of the The Emmes Group. Emmes 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! Why work at Emmes? At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including: Flexible Approved Time Off Tuition Reimbursement 401k Retirement Plan Work From Home Anywhere in the US Maternal/Paternal Leave Casual Dress Code Read Less
  • Clinical Program Manager - Essex Management  

    - Montgomery County
    Overview Clinical Program Manager - Essex Management Remote in US exce... Read More
    Overview Clinical Program Manager - Essex Management Remote in US except, if in Maryland, DC, VA must be comfortable in being on client site at least once a week. This position supports "Essex, an Emmes Company ". Essex is a biomedical informatics and health information technology-focused consultancy founded in 2009 and headquartered in Rockville, MD. The Essex team comprises experts with extensive experience in strategically developing and managing complex health and biomedical information programs for clients in the Federal Government, research academia, and private sectors. Emmes Group: Building a better future for us all. 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! Primary Purpose We are seeking a highimpact, strategic, and executionoriented directorlevel Program Manager to lead and mature the organization's program strategy, delivery excellence, and client enablement capabilities. This role provides both strategic leadership and handson management, including direct oversight of staff and responsibility for career development, coaching, and performance management. This role will shape how internal departmental initiatives and client programs are planned, governed, staffed, measured, and communicated, ensuring delivery rigor while enabling flexibility and innovation across diverse client environments. This role works in close partnership with portfolio, engineering, bioinformatics, data science, and business development leadership to ensure integrated delivery, effective resource utilization, proactive risk management, and an exceptional client experience. The ideal candidate is a decisive people leader and systems thinker who thrives in complex and evolving environments, balances strategy with execution, and brings a strong client first mindset. Success requires the ability to influence at the executive level, mature organizational capabilities, and cultivate a collaborative, empowered team culture that supports excellence in deliveryfirst mindset. Success requires the ability to influence at the executive level, mature organizational capabilities, and cultivate a collaborative, empowered team culture that supports excellence in delivery. Responsibilities Establish and execute departmental goals and objectives aligned to enterprise strategy, contract priorities, and client mission outcomes; define and monitor KPIs to drive accountability and data-informed decision-making. Design, implement, and continuously mature program management, governance, and delivery enablement frameworks that scale across portfolios while ensuring compliance with federal, regulatory, and organizational standards. Provide executive-level visibility into portfolio, program, and project health through standardized dashboards, metrics, and reporting-enabling proactive management of risks, issues, dependencies, and performance trends. Partner with portfolio and divisional leadership to support investment prioritization, funding decisions, and resource allocation, balancing client commitments, growth objectives, and staff sustainability. Ensure full lifecycle contract execution excellence, including initiation, execution, closeout, client reporting, lessons learned, and continuous improvement integration. Lead people management strategy for the department, including performance management, career development, succession planning, training pathways, and promotion readiness. Own departmental workforce and strategic resource planning, including forecasting, recruitment, onboarding, capacity planning, skills development, and certification alignment. Ensure compliance with staff allocations plans, time reporting, and internal policies across billable, internal, and strategic initiatives. Actively support business development efforts, including RFP solutioning, staffing models, transition planning, delivery onboarding, and ongoing executive client engagement. Champion quality-by-design principles across all delivery artifacts and processes; oversee SOP evolution, process training, internal audits, and continuous improvement initiatives. Maintain strong awareness of industry, regulatory, and technology trends; represent the organization through thought leadership, publications, conferences, and strategic forums. Required Skills: Advanced expertise in program, portfolio, and PMO leadership, including framework design, governance models, and delivery maturity assessments (e.g., PMI, PMO, Agile/Hybrid environments). Strong command of program operations, including financial management, forecasting, risk and issue management, resource optimization, and executive reporting. Demonstrated experience leading complex life sciences and health IT programs supporting clinical research, bioinformatics, public health, biomedical informatics, and regulated data environments. Exceptional communication and executive presence, with the ability to influence senior leaders, advise clients, and align cross-functional teams around shared outcomes. Proven problem-solving and systems-thinking capabilities, with a track record of driving process improvement, operational scalability, and organizational maturity. Ability to rapidly assess priorities, adapt to evolving client environments, and translate strategy into executable roadmaps. Strong regulatory and compliance knowledge, including clinical research regulations, healthcare privacy, and federal IT compliance standards (e.g., FDA, 21 CFR Part 11, HIPAA, FISMA, FedRAMP, CMMI, ISO). Experience operating in federal health environments (e.g., HHS, NIH, NCI), with familiarity across consulting delivery models, contract vehicles, and business development lifecycle. Required Areas of Focus: Program Management Leadership Own and evolve client-facing program and project roadmaps, ensuring alignment with mission goals, regulatory requirements, funding constraints, and delivery capacity Contribute to standardized BD-to-Delivery transition processes, ensuring early engagement, clarity of scope, staffing, budgets, timelines, and accountability prior to execution. Ensure consistent contract execution through disciplined tracking of deliverables, milestones, financials, and performance metrics, including CPAR inputs and self-assessments. Design, maintain, and continuously improve enterprise delivery dashboards, providing visibility into: Program and project health summary Resource utilization and capacity Budget performance and forecasting Risk and issue trends Key milestones and outcomes Contract performance and quality metrics Establish and enforce a structured reporting cadence to support proactive leadership engagement and timely decision-making: Weekly: Project and program status Monthly: Portfolio performance and financial reviews Quarterly: Strategic outlook, risk posture, and growth alignment Serve as a senior client relationship leader, cultivating trusted partnerships and proactively identifying opportunities to enhance delivery value and expand engagements. Financial Master's degree in a scientific, health, or program management discipline preferred. PMP or equivalent certification desired. Experience: Minimum of 10 years in senior program strategy and delivery leadership roles across federal, academic, and private-sector environments. Program Leadership: Extensive experience program management, PMO leadership, governance, financial management, and large-scale delivery enablement. Industry Knowledge: Strong background in life sciences, clinical research, bioinformatics, health informatics, and public health. Leadership Read Less
  • Overview Job Title: Director, Product Management Location: US or UK -... Read More
    Overview Job Title: Director, Product Management Location: US or UK - Remote OptymEdge, (part of the Emmes Group), develops proven solutions for training and certification of Visual Function Examiners and Visual Acuity Rooms. OptymEdge partners with study teams to provide visual function certification that ensures a high level of quality and consistency for ophthalmic clinical trial data. OptymEdge is the largest and longest-standing certification organization in the industry. We pioneered visual acuity certification from conception. Our services have grown to be synonymous with providing the highest level of quality and standardization of clinical trial data. Over 2,500 sites certified worldwide, since 1995 Phase I through post-marketing experience across anterior segment and retina trials Clinical Ophthalmology, Optometry, and clinical trial expertise Primary Purpose OptymEdge, a Veridix company within the Emmes Group, is transforming ophthalmology clinical development by digitizing manual processes and data collection into streamlined workflows. Through our Acuvera platform, we leverage technology to build innovative data products that drive efficiency and insight. The Director, Product Management OptymEdge will define and drive the strategy, vision, and execution of a large-scale, cloud-native platform that integrates with external systems and powers data-driven innovation in clinical development. This role leads a team of Product owners, fostering cross-functional alignment, and partnering closely with Engineering, Data, AI/ML, and Business stakeholders to deliver scalable, secure, and high-performing solutions. The job holder combines strategic thinking with hands-on leadership, owning the full product lifecycle from ideation to launch and growth. The Director, Product Management OptymEdgee will shape architecture decisions, manage budgets and resources, and ensure products meet rigorous technical and compliance standards. Responsibilities Strategy comfortable in ambiguous, rapid environments. Domain expertise in life sciences technology (e.g., drug discovery, clinical trials) is preferred. Emmes Group: Building a better future for us all. OptymEdge is part of the The Emmes Group. Emmes 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! CONNECT WITH US! Follow us on Twitter - @EmmesCRO Find us on LinkedIn - Emmes #LI-Remote Read Less

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Astrid-Lindgren-Weg 12 38229 Salzgitter Germany