Associate Clinical Study Manager

Associate 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 Associate Clinical Study Manager (CSM) is responsible for assisting with operational support activities for a protocol or group of protocols, including guiding study timelines for clinical research studies at external trial sites.

Responsibilities
  • Participates in activities that ensure quality, consistency and integration of study data to agreed time, cost and quality objectives.
  • Communicates with internal and external collaborators regarding status of tasks and updates.
  • Assists in facilitating study development, implementation, management, and closeout activities in accordance with corporate and project-level Standard Operating Procedures and any client/sponsor requirements or guidelines.
  • Possesses detailed knowledge of the study and its associated activities and timelines.
  • May function as the site staff/investigator-facing point of contact.
  • Assists with the practical arrangements and preparation of internal and external meetings e.g. study team meetings; distribute agenda, take minutes and keep lists of action items and decisions made
  • Attends and participates in project and functional group meetings
  • Collects, reviews and tracks study documents (e.g., protocol, MOP), as required by the study
  • Contributes to coordination and tracking of study materials and supplies (e.g., pregnancy tests, ECG machines).
  • Consults with the TMF service group to determine essential regulatory document requirement
  • Coordinates tasks during the study process, audits and regulatory inspections under the supervision of the CSM Manager.
  • May assist with the dissemination of current material to research site staff and may assist with providing training on updated documents and procedures
  • May assist with study-level supplies and investigational product/device accountability, including coordination with vendors.
  • Assists with monitoring study and site progress, identifying and resolving with the
  • CSM Manager issues which may impact delivery of the study or to the necessary quality, timeline or budget objectives.
  • Remains informed of data system progress and data management activities, as well as other project-related activities by the other Clinical Operations verticals.
  • May assist with site contract management responsibilities

Experience
  • Bachelor's degree in a scientific discipline
  • Minimum 1 years of clinical research experience
  • 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
  • Ability to function effectively on a team, providing and receiving constructive feedback
  • Communicates and coordinates effectively with internal project staff members, site staff, sponsors, clients and other external colleagues


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


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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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