Trial Master File Associate Jobs in Ashburn, VA (NOW HIRING)

Clinical Trial Manager IBe Part of One Team, One Purpose.At Emmes Group, we're shaping the future of clinical research-where human intelligence meets cutting-edge technology to drive meaningful advancements in healthcare. With over 47 years of scientific excellence, we've led groundbreaking research in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience.Through our two business units-Emmes, a full-service CRO, and Veridix AI, our technology, data, and analytical solutions -we are modernizing clinical trials and accelerating the development of life-changing therapies.We believe that every clinical breakthrough starts with people-people who are passionate, purpose-driven, and ready to make an impact. At Emmes Group, we bring People, Science, and Technology together to collaborate with our customers and deliver global health impact. Our culture is built on integrity, collaboration, and innovation, ensuring that every challenge is met with perseverance and accountability.The Clinical Trial Manager (CTM) I is responsible for the leadership of operational activities for a study or group of studies at a regional level, including tracking progress and quality at clinical sites. The CTM I will oversee the monitoring team and associated deliverables, including the clinical monitoring plan, site visit reports, etc. In addition, the CTM I works to ensure clinical trial timelines are being met and communicated to the Project Leader/Global Clinical Project Manager. The CTM I will oversee site management and site monitoring activities.

• Possesses detailed knowledge of the study protocol and its associated activities and timelines.
• Provides mentoring, training, and oversight for Clinical Research Associates CRAs, in house CRAs, and other site management staff on assigned projects.
• Coordinates and facilitates 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.
• Provide forecast projections to GPM and track clinical team overburn/underburn.
• 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, may serve as the client sponsor facing point of contact for operational activities as outlined in the study's Communication Plan.
• Participates in or leads internal and external study calls and meetings.
• Escalates issues or concerns regarding study activities to line management and the department leadership as needed.
• Participates in 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. Contributes to operational review of the protocol if applicable.
• Participates in the development and review of key templates such as master informed consent forms 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 study 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 or targeted monitoring strategy, monitoring visit frequency, monitoring visit report submission approval timelines, study data collection timelines, and the annotated reports, per the project SOW andor Emmes SOPs.
• Evaluates current operational practices and recommends process improvements to ensure continued compliance with regulatory requirements
• Maintains metrics related to site assessments, feasibility and selection, site activation and close out activities.
• Tracks site performance metrics and quality. Stays up to date on overall study progress at the sites and identifies risk, example, recruitment rates, missing data, investigational product inventory and expiration, protocol compliance, safety reporting, regulatory issues, etc.
• 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, example, 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.
• May assist with bid defense preparation and conduct or in the RFP proposal process.
• May assist with DSMB DMC coordination and management.
• Provide forecast projections to GPM and track clinical team overburn/underburn
• Performs other duties as assigned
• Complies with all policies and standards

• Bachelor's Degree Science related field. Required
• Master's Degree Science related field. Preferred
• 4-6 years 5 years of relevant clinical research experience, Required
• 1-3 years Experience CRA or in a clinical operations coordinating role. Required
• Excellent team building and interpersonal skills. High
• Excellent organizational and analytical skills. High
• Excellent verbal and written communication skills. High
• Excellent ability to prioritize and handle multiple tasks. High
• Ability to work independently, as well as in a complex team environment. High
• Proficient with MS Office Suite High
• Excellent computer and organizational skills High
• High attention to detail required High
• Ability to work on varying projects and exercise critical thinking High
• self starter who can work independently and a team player who can work cross functionally with limited oversight High
• Knowledgeable in clinical research operations, including interpretation and implementation of country specific regulations and ICH guidelines, as required High
• Excellent organizational, interpersonal, and communication skills both oral and written High
• Demonstrated problem solving skills, self motivated, and adaptable to a dynamic environment High
• Knowledgeable in prioritization, problem solving, organization, critical thinking, decision making, time management, and planning activities High
• Ability to collaborate with internal and external colleagues and work well in a team oriented setting High

If you're looking for a career where your work advances global health and where scientific excellence meets real-world impact, join us and be part of something bigger. One Team, One Purpose.CONNECT WITH US!Find us on LinkedIn:/the-emmes-group/Visit our website:https://www.theemmesgroup.com/