Senior Clinical Study Manager

Location
Rockville, Maryland
Salary
Competitive
Posted
Jun 10, 2021
Closes
Jul 10, 2021
Ref
2886
Function
Management
Industry
Science
Hours
Full Time
Senior 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 Senior 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 and providing active problem-solving.

Responsibilities
  • 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

Experience
  • Bachelor's or Master's degree in a scientific discipline
  • Minimum 5 years of relevant research or clinical study experience
  • 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


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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