Clinical Trial Manager II (Oncology or Cell and Gene Therapy)

Overview

Clinical Trial Manager I (Oncology or Cell and Gene therapy) 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 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 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.
• 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 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 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 and/or 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 site(s) and identifies risk (e.g., 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 (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.
• May assist with bid defense preparation and conduct or 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.
• Incumbent will typically possess at least 5 years of relevant clinical research experience, including time as a CRA or in a clinical operations coordinating role.
• Oncology or Cell and Gene therapy experience.
• 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

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