Clinical Trial Manager I

Emmes; Rockville (MD); Remote; USD 90,000 - 120,000; Full time

Benefits offered by this job

Flexible Approved Time Off

Tuition Reimbursement

401k Retirement Plan

Work From Home Anywhere in the US

Maternal/Paternal Leave

Casual Dress Code & Work Environment

Job summary

Emmes is seeking a Clinical Trial Manager I to lead regional operational activities and monitor study progress. You will oversee the monitoring team, ensure timelines, and mentor CRAs and site staff across projects.

The role emphasizes client communication, SOP adherence, and cross-functional collaboration from a remote US-based setting. Ideal candidates will have a science background, 4–6 years in clinical research, and 1–3 years in CRA/clinical operations roles, with strong teamwork and

Qualifications

• Bachelor's degree in a science-related field is required.
• Master's degree in science is preferred.
• 4-6 years of relevant clinical research experience required.
• 1-3 years experience as CRA or in a clinical operations coordinating role required.
• Excellent team-building and interpersonal skills emphasized.
• Strong organizational and analytical capabilities highlighted.

Responsibilities

• Oversee the monitoring team and deliverables for regional studies.
• Lead operational activities and ensure timelines are met.
• Mentor CRAs and site management staff on projects.
• Coordinate study tasks according to SOPs and client requirements.
• Maintain client, vendor, and internal stakeholder relationships.
• Monitor study plans, CMP, MOP, and other templates for compliance.
• Track site performance metrics and study progress.
• Communicate status updates to study leaders and teams.

Skills

Team leadership

Organization

Communication

Independent work

MS Office

Attention to detail

Prioritization

Analytical skills

Education

Bachelor's degree in science

Master's degree (preferred)

Job description

Overview

Clinical Trial Manager I

Be 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.

Responsibilities

• 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

Qualifications

• 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

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 ourEmmes Carescommunity 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 & Work Environment

CONNECT WITH US!

Find us on LinkedIn:/the-emmes-group/

Visit our website:https://www.theemmesgroup.com/

The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.

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