Clinical Study Manager

Location
Rockville, Maryland
Salary
Competitive
Posted
Jan 19, 2023
Closes
Feb 18, 2023
Ref
3662
Function
Management
Industry
Science
Hours
Full Time
Clinical Study Manager

US Remote Worker

The Emmes Company, LLC ("Emmes") is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience, we have learned that collaborative relationships thrive and human health benefits when truth is our compass.

Our "Character Achieves Results" culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.

If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee — from entry level through top executive — to contribute to our clients' success by sharing ideas openly and honestly.

Primary Purpose

The Clinical Study Manager is responsible for assisting with operational support activities for a study or group of studies, including monitoring study timelines for clinical research studies at external trial sites. The Clinical Study Manager will work to problem-solve as needed and will make most decisions in consultation with others as relevant.

Responsibilities

· Study Management

o Possesses detailed knowledge of the study and its associated activities and timelines

o Contributes to study development, implementation, and closeout activities in accordance with corporate and project-level Standard Operating Procedures (SOPs) and any client/sponsor requirements or guidelines

o Coordinates the implementation of a study, including assisting with task management and oversight of activities specific to each phase of the study lifecycle

o Tracks study progress, proactively identifying and resolving with the CSM Manager and Project Leader/Clinical Project Manager issues which may impact delivery of the study or adherence to the necessary quality, timeline, or budget objectives

o May review, where applicable, Clinical Trial Management Systems (CTMS), drug management, safety, Case Report Form (CRF), Trial Master File (TMF), and other dashboards for broad oversight of project team and site conduct.

· Communications

o Communicates with internal and external collaborators regarding status of tasks and updates

o May function as a client/sponsor-facing point of contact

o Establishes and maintains strong working relationships with clients, external investigators, research site study staff, vendors, and internal collaborators

o Maintains open communication with study staff at the research site(s); functions as point of contact for study questions and operational issues

o Attends, participates, and may help organize or facilitate project and functional group meetings, including preparation of agendas and minutes

o Escalates issues or concerns regarding study activities

· Documentation and Reports

o Contributes to the development of key study documents such as the clinical study protocol, Manual of Procedures (MOP), informed consent form (ICF) and other participant-facing documents, Standard Operating Procedures (SOPs), site training materials, Site Monitoring Plan, pharmacy/lab manuals, TMF plan and associated updates/amendments to these documents

o Tracks study document currency and ethics committee approvals, as applicable

o Assists with dissemination of current materials to research site staff and may assist with providing training on updated documents and procedures

o Assists in preparing or reviewing reports, e.g. DSMB Reports, IND Annual Reports, or other project progress reports

· Site Management

o Responsible for study-level supplies and investigational product/device accountability, including coordination with vendors

o Assists as needed with site management by maintaining knowledge of site status, performance metrics and quality.

o Tracks and may support site start up and close out activities.

o May assist with site contract, budget and payment tracking.

· Internal Collaboration

o Remains informed of data system progress and data management activities as needed. May review data management documents and processes for alignment to the study protocol and operational guidelines.

o Consults with the TMF service group to determine essential document status and requirements

o Remains informed of site monitoring schedules and procedures; may offer consultation on the Site Monitoring Plan, Site Visit Reports, and Site Visit Preparation and Follow-Up

o 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

o Under the direction of the CSM Manager, may participate in project process improvement and quality assurance activities such as 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

· Other Duties as assigned



Experience

· Bachelor's degree in related scientific discipline, or equivalent work experience in directly related fields

· Excellent verbal and written communication and presentation skills

· Demonstrates ability to work independently as well as in a team environment

· Proven organizational and analytical skills



Emmes is a federal government contractor and requires all employees to be fully vaccinated against COVID-19, to the extent permitted by applicable law. Individuals with medical conditions or sincerely religious beliefs or practices that prevent them from getting the vaccine may request an exemption from the vaccine requirement.

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 our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:



· Unlimited Approved Leave



· Tuition Reimbursement



· 401k & Profit Sharing Plan

· Work From Home Anywhere in the US



· Maternal/Paternal Leave



· Casual Dress Code & Work Environment



CONNECT WITH US!

Follow us on Twitter - @EmmesCRO

Find us on LinkedIn - The Emmes Company, LLC

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.

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