Designs, develops, and enhances cloud-based, SaaS web-based clinical trials applications Collaborates with product, engineering, and software quality assurance (SQA) team members for integration, design, and verification in an agile environment Adheres to best practices and Emmes quality standards for code security, optimization, and reusability Uses established frameworks for a seamless user experience across platforms Performs unit testing, debugging, and troubleshooting as needed to ensure quality of work Performs code reviews, assesses regression impact for design changes, and completes technical documentation Identifies opportunities for refactoring/reworking major modules and sees implementation through to deployment Mentor and coach junior and mid-level developers, promoting a collaborative and learning-driven environment Conduct regular code reviews, provide feedback, and foster a culture of continuous improvement Encourage the team to experiment with new technologies, techniques, and methodologies Overview 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 Designs, develops, and enhances cloud-based, software-as-a-service (SaaS) web-based clinical trials applications Responsibilities Designs, develops, and enhances cloud-based, SaaS web-based clinical trials applications Collaborates with product, engineering, and software quality assurance (SQA) team members for integration, design, and verification in an agile environment Adheres to best practices and Emmes quality standards for code security, optimization, and reusability Uses established frameworks for a seamless user experience across platforms Performs unit testing, debugging, and troubleshooting as needed to ensure quality of work Performs code reviews, assesses regression impact for design changes, and completes technical documentation Identifies opportunities for refactoring/reworking major modules and sees implementation through to deployment Mentor and coach junior and mid-level developers, promoting a collaborative and learning-driven environment Conduct regular code reviews, provide feedback, and foster a culture of continuous improvement Encourage the team to experiment with new technologies, techniques, and methodologies Qualifications 6 or more years of related professional experience Min 4 years of experience in ReactJS and JavaScript/Typescript Min 4 years of experience in web platform development tools like Node js, Express, AWS Amplify, AWS Lambda, AppSync, and GraphQL Min 4 years of experience in working with any relational or No SQL database Min 2 years of experience in leading a team of engineers Expertise in developing Single Page Applications (SPA) Expertise with authentication and data caching Expertise in API security Expertise with DynamoDB, Amazon Aurora, or other relational database management system Experience with source code repositories like AWS CodeCommit, Git/GitHub, or SVN Experience working in an agile team CONNECT WITH US! Follow us on Twitter - @EmmesCRO Find us on LinkedIn - Emmes

Acts as an SME on eTMF application features related to TMF Operations, TMF processes, document identification/filing. Adheres to the TMF Plan/Index created by Lead/Senior TMF Specialist and ensures that TMF document collection is in line with the TMF Plan/Index. Contributes to the identification of expected documents based on filed documents. Ensures the TMF file structure follows applicable company approved TMF configuration, regarding ICH Guidelines for Good Clinical Practice, Good Documentation Practices and the TMF Reference Model, as required. Contributes to SOPs (Project and Corporate), company guidelines, work instructions and templates (e.g., Quality management, reports and metrics, TMF quality control (QC)/ quality assurance (QA) activities, etc.) to ensure that TMF Operations tasks are performed in adherence with ICH/GCP/regulatory guidelines and best practices. Support implementation of features of Veeva Vault eTMF system in conjunction with the Clinical Systems Manager. Acquires expertise in eTMF applications used for studies where sponsor eTMF is chosen as TMF repository. Contributes to streamlining the processes and implementing automation such as VBA macros, Robotic Process Automation (RPA), system integration, Artificial Intelligence (AI)/Machine Learning (ML). Perform tasks within eTMF application to maintain the lifecycle of the TMF (e.g., EDL maintenance, reports and metrics, etc.) Overview 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 The Associate TMF Specialist is primarily responsible for uploading and indexing the TMF documents in eTMF or filing, organizing and maintaining documents in paper TMF with a strong focus on ensuring that routine operations are performed with adherence with SOPs (Project and Corporate) and ICH/GCP/TMF guidelines. Responsibilities Acts as an SME on eTMF application features related to TMF Operations, TMF processes, document identification/filing. Adheres to the TMF Plan/Index created by Lead/Senior TMF Specialist and ensures that TMF document collection is in line with the TMF Plan/Index. Contributes to the identification of expected documents based on filed documents. Ensures the TMF file structure follows applicable company approved TMF configuration, regarding ICH Guidelines for Good Clinical Practice, Good Documentation Practices and the TMF Reference Model, as required. Contributes to SOPs (Project and Corporate), company guidelines, work instructions and templates (e.g., Quality management, reports and metrics, TMF quality control (QC)/ quality assurance (QA) activities, etc.) to ensure that TMF Operations tasks are performed in adherence with ICH/GCP/regulatory guidelines and best practices. Support implementation of features of Veeva Vault eTMF system in conjunction with the Clinical Systems Manager. Acquires expertise in eTMF applications used for studies where sponsor eTMF is chosen as TMF repository. Contributes to streamlining the processes and implementing automation such as VBA macros, Robotic Process Automation (RPA), system integration, Artificial Intelligence (AI)/Machine Learning (ML). Perform tasks within eTMF application to maintain the lifecycle of the TMF (e.g., EDL maintenance, reports and metrics, etc.) Qualifications Bachelors degree requited, preferably in scientific discipline. Incumbent typically will possess 0 to 3 years of Clinical Operations/Filing documents experience in TMF Operations. Knowledge of filing procedures and eTMF application is mandatory. Experience in Veeva is desirable. Competent computer skills including ability to take on board new systems. Capability of managing competing priorities in a changeable environment and ability to handle stressful situations/deadlines. Thorough knowledge of GCP and TMF governing regulations, such as the TMF Reference Model required. Experience in NIH-sponsored clinical programs is a plus. Assertiveness, technical background, integrity. Good organizational, planning, analytical, and problem-solving skills. Attention to detail required. Ability to build and maintain positive relationships with management, peers, and subordinates. Excellent verbal and written presentation, communication skills along with fluency in English are necessary. Highly motivated, results driven with unyielding predisposition to detail and accuracy. Possess high degree of initiative. CONNECT WITH US! Follow us on Twitter - @EmmesCRO Find us on LinkedIn - Emmes

Overview Associate Global Project Manager India Remote - Bengaluru 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 The Associate Global Project Manager (AGPM) is critical to the successful conduct of Biopharmaceutical-sponsored clinical trials as a matrix leader of the core project team. The AGPM is responsible for the successful delivery of a Biopharmaceutical project(s). Responsibilities May serve as a lead for project bids and multi trial initiatives. Ensures that deliverables for assigned project(s) are completed according to the contract budget, schedule, and quality standards. Manages projects in all areas of performance. Develops successful working relationships with clients, executive management, and project staff. Collaborates with stakeholders to manage project issues, proactively identify and mitigate risks and drive milestone achievement. May serve as the primary point of contact for assigned biopharma clients. Demonstrates proficiency in knowledge and understanding of client needs. Tracks project deliverables against contract using Emmes’ tools. Prepares/presents study metrics to maintain transparency for internal/external stakeholders. Monitors trends and drives changes to the plan as needed; identifies risks to delivery and supports development of mitigation plans with the project team. Ensures adherence to quality control expectations and milestone timelines for delivery of contractually required reports and deliverables. Manages project resources (i.e., budget, personnel, and subcontracts). Identifies and manages changes to scope and requests for out-of-scope activities. Collaborates with Business Development, Contracts Department, and executive management to ensure timely execution of contract amendments/change orders. Prospectively manages client expectations. May support bid defense meeting presentations in collaboration with Business Development for assigned clients. Develops study management plans in collaboration with core project team members. Identifies and documents lessons learned from study successes and challenges to promote development of best practices. Models and propagates Emmes’ commitment to a culture of quality in all aspects of our deliverables, utilizing a solution-based, science-driven, value-added approach in collaborating with clients. Performs other duties as assigned. Qualifications Bachelor’s degree in a scientific discipline. Minimum of 4 years demonstrating scientific principles appropriate in managing a clinical research portfolio. Minimum of 1 year in a pharmaceutical and/or CRO setting, serving in a Project Manager or equivalent position. CONNECT WITH US! Follow us on Twitter - @EmmesCRO Find us on LinkedIn - Emmes Show more Show less

Overview 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 The Senior Project Manager, Initiatives is responsible for the project life cycle for various organizational initiatives, some of which are listed in the Emmes Strategic Scorecard. This position works closely with members of the Executive and Operations Team, who serve as Executive Sponsors of initiatives. This position is expected to hold information confidential and act as a trusted confidant of Executives. The Senior Project Manager, Initiatives will manage all aspects of assigned initiatives of varying complexity and medium to large size by assembling work groups, assigning individual responsibilities, identifying needed resources, developing schedules to ensure timely project completion, identifying critical capabilities, project resources, budgets, risks and critical path issues. As the senior member of the team, this position provides training, coaching and mentoring to junior team members, and manages direct reports Responsibilities Manages overall initiative lifecycle, including the day-to-day activities of planning, coordinating, implementing, monitoring, documenting, and completing assigned initiatives across global teams. Monitors initiatives to ensure initiative framework processes are being followed and project management best practices are being used, including reporting on metrics related to initiative health, completion of milestones on time and within budget, and adoption of effective change management processes. Coordinates tasks and communication within and across teams and develops presentation materials for projects and executives. Partners with business leaders to ensure alignment of initiative scope and deliverables with business and corporate strategies. Facilitates or leads initiative meetings to develop efficient and effective future state outcome and to identify deliverables needed to ensure initiative goals are met. Works with Business Analyst Manager to develop an effective change management plan for assigned initiatives, then serves as the change agent champion and lead the execution of the change management plan. Compiles and provides monthly initiative status reports, KPIs and metrics related to health of assigned initiatives to executive sponsors, stakeholders, and peers, including key updates, cost, schedule, status, and risks. Exercises independent discretion and judgment to solve complex problems regarding project, department, or division-related work. Promotes, develops, and maintains disciplined initiative project management models and frameworks (and related tools and processes) across Emmes and its subsidiaries; ensures adherence, adoption, implementation, and review of lessons learned. Initiates and shares learning opportunities for the initiative team to continue to grow as professionals. Coordinates activities with Business Analyst and/or Application Analyst assigned to initiative. Assists with tracking project expenditure. Provides training, coaching, and mentoring to junior team members. Provides management to direct reports and leadership to full team. Manages vendor relationships during vendor-run implementations. Performs other duties as assigned. Qualifications Undergraduate degree in business or humanities field preferred. 10+ years of project/program/portfolio management experience with demonstrated increase in responsibility and project complexity, including managing enterprise level business and technology transformation projects as well as resource management, financial management, and/or budget analysis. PMP or equivalent certification and a proven track record of successfully managing projects in a fast-paced business. Experience building customer and stakeholder relationships with a focus on problem resolution. Experience explaining technical terms to non-technical staff. Exceptional project management skills with ability to multitask and manage multiple projects across diverse global teams in a highly matrixed environment. Demonstrated planning and project management skills. Excellent listening, communication, presentation, interpersonal skills, both written and verbal, with an ability to inform, influence, convince and persuade. Strong skills in prioritization, organization, decision-making, time management, and planning. Ability to drive to tangible results in a timely manner even when the work involves a highlevel of ambiguity. Skilled in facilitating meetings with multiple stakeholders, including building consensus, motivation, and managing conflict. Strong analytical, problem-solving, and troubleshooting skills; with the ability to collect, organize, analyze, and disseminate significant amounts of information with attention to detail and accuracy. Ability to demonstrate strategic thinking capability, exercise good judgement, make sound decisions, and escalate issues/decision making as appropriate. Knowledge of technology concepts including Software Development Life Cycle (SDLC), process improvement, and agile methodologies is preferred. Experience in O365, Smartsheet or MS Project, and Jira is preferred. CONNECT WITH US! Follow us on Twitter - @EmmesCRO Find us on LinkedIn - Emmes Show more Show less

Overview Overview 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 stive 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 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 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. Performs other duties as assigned Complies with all policies and standards Qualifications Qualifications Bachelor's Degree Required or Master's Degree preferably in a science related field Required 7-9 years 7-8 years of relevant clinical research experience, including time as a CRA or in a clinical operations coordinating/leadership role Required 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 Excellent organizational, interpersonal, and communication skills (both oral and written) 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 Show more Show less