The Emmes Company, LLC ("Emmes") is searching for a Clinical Study Manager based out of our Rockville, Maryland, Frederick, Maryland and/or Tysons Corner, Virginia office. Emmes provides flexibility for the office location or remote work preference, dependent upon position.
The Emmes Company, LLC is a Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over six hundred staff worldwide with offices located in Frederick, Maryland, Tysons Corner, Virginia, Vancouver, Canada and Bangalore, India. Ranked as a top area workplace of choice by the Washington Post, Emmes fosters an environment of collaboration, professional growth, and exceptional work life balance.
Our studies impact public health initiatives on a global scale occurring in more than sixty countries spanning across six continents. We are dedicated to providing statistical and epidemiological expertise, computer systems deployment, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in biomedical research. Emmes offers support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation.
The MacTel Project is designed to identify the causes and possible treatments for Macular Telangiectasis Type 2 (MacTel Type 2), an uncommon and poorly understood retinal vascular disease.
Emmes serves as the Coordinating Center for the Natural History Study, the Extension of the Phase I and Phase II trials, and the Phase III international multi-center clinical trial to assess the safety, tolerability, and efficacy of Ciliary Neurotrophic Factor (CTNF), a class of molecules that has been demonstrated to slow the loss of photoreceptor cells during retinal degeneration. These studies involve implanting a capsule into the vitreous of the eye that secretes the CNTF, thus making the molecules available to the photoreceptor cells of the retina. This capsule is called the NT-501/Renexus device.
The Natural History Study enrollment is ongoing, the Phase I and Phase II Extension Study is in the follow-up/data collection phase, and the Phase III clinical trial is in the start-up/enrollment period.
Emmes provides statistical services, regulatory support, data management, medical monitoring, on-site monitoring, data/text/tables for IND/DSMC/Safety Reports, and project management for approximately 60 Natural History sites in the US, Australia, and Europe and 45 Clinical Trial sites in the US, Australia, and Europe.
- Coordinates and facilitates each phase of the lifecycle of a study, including management of tasks and oversight of activities specific to each phase of the study lifecycle in accordance with corporate and project-level Standard Operating Procedures and any client/sponsor requirements or guidelines
- Communicates with internal and external collaborators regarding status of tasks and updates and is responsible for communication of status of activities to internal teams
- Functions as the site staff/investigator-facing point of contact, maintaining open communication with study staff at the research site(s), answering questions and assisting with operational issues
- May serve as the client/sponsor-facing point of contact for activities, if applicable, as outlined in the study's Communication Plan
- Participates in or leads internal and external study calls and meetings; triages site or sponsor/client needs to internal teams, as appropriate, and ensures needs are addressed
- Establishes and maintains strong working relationships with clients, external investigators, research site study staff, vendors, and internal collaborators
- Escalates issues or concerns regarding study activities to the CSM Manager
- Participates in the review of key study documents such as the clinical study protocol, Manual of Procedures (MOP), informed consent form(s) and other participant-facing documents, standard operating procedures (SOPs), site training materials, Site Monitoring Plan, pharmacy/lab manuals, TMF plan, etc.
- Reviews material to be distributed to research site staff and may assist with providing training on updated documents and procedures
- Assists in preparing or reviewing reports, e.g. DSMB Reports, IND Annual Reports, or other project progress reports
- Stays up to date on overall study progress at the site(s) (e.g., recruitment rates, missing data, investigational product inventory and expiration dating, regulatory issues, etc.)
- Assists as needed with site management by maintaining knowledge of site performance metrics and quality
- 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, etc.
- Consults with the TMF service group to determine essential regulatory document requirements
- 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
- Under the direction of the CSM Manager participates in project process improvement and corporate quality assurance activities such as through Internal Quality Audit Team (IQAT), project SOP and Compliance/Variance table development and reviews, participation in internal and external audits, functional group meetings, continuing education and other professional development activities
- Responsible for study-level supplies and investigational produce/device accountability, including selection of and coordination with vendors
- Attends and contributes to project and functional group meetings, may serve as a representative on external calls as required
- May assist with site contract management responsibilities
- Bachelor's or Master's degree in a scientific discipline
- Minimum 3 years of relevant research or clinical study experience
- Prior ophthalmology research experience is a plus
- Excellent team building and interpersonal skills
- Skills in prioritization, problem solving, organization, decision-making, time management, and planning
- Prior knowledge of GCP, HSP, and regulatory guidelines and regulations helpful
- Detail-oriented, excellent presentation, oral, and written communication skills required
- Communicates and coordinates effectively with internal project staff members, site staff, sponsors, clients and other external colleagues
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The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.