Emmes Group

Veridix AI is the technology, data, and AI arm of the Emmes Group, a leading full-service contract research organization (CRO) with over 47 years of experience in supporting clinical research across more than 70 countries. With industry-leading capabilities in cell and gene therapy, vaccines, infectious diseases, and ophthalmology, Emmes is one of the top clinical service providers to the U.S. government and is rapidly expanding its presence in biopharma. Veridix AI develops advanced eClinical solutions, powering clinical trials through patient data collection, randomization, biospecimen tracking, and data quality monitoring. Our cutting-edge AI innovations, including Generative AI (GenAI) capabilities, are transforming clinical trial timelines by streamlining processes from document authoring to automating study builds. Our “Character Achieves Results” culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships, and Intellectual Curiosity. If you share our motivations and passion in research, come join us!

Clinical Trial Manager II

Location

United States

Posted

13 days ago

Salary

0

Seniority

Lead

No structured requirement data.

Job Description

Clinical Trial Manager II

Emmes Group

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

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