Principal (Lead) Clinical Study Manager

Rockville, Maryland
Nov 15, 2020
Dec 14, 2020
Full Time
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The Emmes Company, LLC is searching for a Principal (Lead) 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 work remote preference dependent upon position.

The Emmes Company, LLC is a private Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over seven 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.

Primary Purpose

The Principal Clinical Study Manager is responsible for the operational support activities for a protocol or group of protocols, including leading study timelines for clinical research studies at external trial sites. Work closely with internal project members to ensure compliance with regulatory requirements, ICH guidelines, Standard Operating Procedures (SOPs), the study protocol and overall research objectives. Ability to problem solve and make decisions independently, while providing operational subject matter expertise for a project or therapeutic area.


  • Study Management
    • Possesses comprehensive knowledge of one or more studies and associated activities and timelines
    • Maintains responsibility for facilitating all phases of the study from study development, implementation, management and through closeout activities in accordance with corporate and project-level Standard Operating Procedures and any client/sponsor requirements or guidelines
    • Serves as the internal subject matter expert on the global status of study activities and is responsible for communication of overall status of activities to internal teams and/or client/sponsor as needed
  • Communications
    • Serves as the primary site staff/investigator-facing point of contact
    • Collaborates closely with external client/sponsor representatives and internal team members across service areas to manage the study; leads or actively participates in internal and external study calls and meetings and ensures needs are addressed
    • Maintains open communication with study staff at the research site(s); serves as primary point of contact for study questions and operational issues; may be responsible for conducting training
    • Builds 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 leadership team, including but not limited to adherence with timelines, client expectations or satisfaction, quality of work, research site problems or complaint
    • May be required to present at meetings, conferences, and other events representing Emmes; including job fairs or other external events
  • Documentation and Reports
    • Participates in the development and/or 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.
    • Ensures that key study documents remain accurate throughout the study lifecycle and facilitates updates as needed; may be responsible for submitting changes for ethics committee approval. Ensures current materials are disseminated to research site staff and may be responsible for providing training on updated documents and procedures
    • May be involved in preparing or reviewing reports, e.g. DSMB Reports, IND Annual Reports, or other project progress reports
  • Site Management and Monitoring
    • 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.)
    • Maintaining knowledge of site performance metrics and quality, such as:
      • Progress on tasks required for site initiation/closeout (e.g., submission of essential documents)
      • Protocol adherence (e.g., through review of protocol deviations)
      • Continued compliance with Good Clinical Practice and other regulatory requirements
      • Data quality and site monitoring action observations and action items
    • May be responsible for study-level supplies and investigational produce/device accountability, including coordination with vendors
    • May assist with site contract management responsibilities
  • Internal Collaboration
    • Data Management
      • Remains informed of data system progress and data management activities; serves in a consultative role as it relates to the study protocol and operational guidelines, report development, data collection requirements, etc.
    • Regulatory Operations
      • Consults with the TMF service group to determine essential regulatory document requirements; maintains open communication to discuss regulatory documentation issues and ensure that documents are being collected and maintained as required
    • CRA Services
      • 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
    • Safety/Medical Monitor
      • 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
  • Corporate Activities
    • Participates in project process improvement and corporate quality assurance activities through Internal Quality Audit Team (IQAT), project SOP and Compliance/Variance table development and reviews, participation of internal and external audits, functional group meetings, continuing education and other professional development activities
  • May or may not provide direct line support for CSM staff. For direct reports:
    • Collaboratively conducts performance and compensation review activities with the applicable project leader or designee
    • Responsible for addressing employee relations issues and resolving problems
    • Ensures CSM salary and bonus equity compliance
    • Approves timesheets, expense reports, and leave requests

  • Bachelor's degree required, preferably in a scientific discipline, with at least 6 years of progressive experience working in a clinical research environment, with advanced understanding of the clinical study development processes, scientific terminology and methods.
  • Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
  • High attention to detail, ability to multi-task and collaborative
  • Strong computer skills: ability to learn new technology and systems and prior experience with computerized data capture systems
  • Ability to operate effectively in a multi-disciplinary, team-oriented culture that emphasizes professional development


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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.

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