Clinical Trial Manager II

Overview

Clinical Trial Manager II

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 U.S. 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 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.

• 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…