Manager, Clinical Study Management

The Emmes Company, LLC is searching for a Manager, Clinical Study Management. Emmes provides flexibility for the office location or work remote preference dependent upon position.

The Emmes Company, LLC is a Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over one thousand staff worldwide with offices located in Frederick, Maryland, 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 Manager, Clinical Study Management maintains overall responsibility for the operational support activities for a protocol or group of protocols, including monitoring study timelines for clinical research studies at external trial sites. This role will provide the highest possible quality and efficiency of focused operational support to Emmes' projects and its corresponding sponsors to create value to the project.

Responsibilities

  • Has all accountabilities, duties, and responsibilities of a Clinical Study Manager (CSM) at the level at which they are working. In addition to their role as a Clinical Study Manager on a Project, the individual also serves as a direct supervisor to other CSMs
  • Provides oversight for Study Management activities for CSM staff
  • Works collaboratively within CSM and with all other interfaces and stakeholders internally and externally as required to ensure highly effective clinical supply planning and execution
  • Applies skills and knowledge to advise and develop improvements appropriate to enable ongoing seamless and efficient Study Management practices within the CSM group
  • Provides Direct Report Management to CSMs
    • Develops/oversees recruitment/retention strategy and related initiatives
    • Approves timesheets, expense reports, and leave requests
    • 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
    • Escalates performance issues to Clinical Study Management leadership
  • Ensures salary and bonus equity against others in Functional Group
    • Conducts Quarterly reviews (recommended)
    • Conducts weekly/bi-weekly meetings with direct reports (recommended)
    • Complete Performance Improvement Plan (PIP) as needed
    • Conduct regular performance assessment and provide quality service oversight to projects
    • Maintain open communication with project staff, with a focus on CSM performance and budget considerations
    • Discuss resource allocation support, including how this might be impacted by budget (e.g., staff compensation changes)
    • Establish open communication and feedback with project leadership on CSM support
    • Discuss quality and timeliness of delivery of CSM services
    • Discuss and implement corrective action as needed


Experience
  • Bachelor's degree required, preferably in a scientific discipline, with at least 5 years of clinical study management experience within pharma and/or CRO and at least 3 years with lead or supervisory experience
  • 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
  • Ability to demonstrate strategic thinking capability with strong project management focus as well as focus on execution of strategic decisions while balance conflicting priorities
  • 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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