Clinical Study Manager - Remote

Clinical Study Manager

Canada 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 (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. The CSM will identify problems and propose solutions, while making decisions in consultation with others as relevant.

Responsibilities

• Assist investigators with concept and protocol development, approval, and revision processes as required by the protocol team, pharmaceutical collaborators, correlative science collaborators, and other resources
• Coordinate the development of and revision of protocol-specific documentation (e.g. Operations Manuals, Standard Operating Procedures, work instructions, and other required documentation)
• Critically review and comment on study protocols, informed consents and other study documents
• Triage incoming site inquiries to the appropriate team member and ensure follow up as needed Moderate monthly working group calls, protocol development calls and other relevant conference calls for assigned disease area
• Contribute to the quality and accuracy of clinical study reports
• Identify site staff training needs, support the development of training materials, and deliver training
• Identify and track site and protocol related deliverables for the lifecycle of a study
• Meet deadlines for deliverables to sponsor
• Create and manage timelines (initiation, implementation and closeout) and other tasks as needed
• Collaborate with internal and external team members to improve study conduct, monitoring and assure compliance with study procedures
• Write study specific memoranda, major email communications, and other study specific communications
• Assist with clinical study drug procurement and importation to clinical sites, as needed
• Document workflow for assigned tasks
• Support protocol safety reviews and cohort management for dose escalation/de-escalation trials, including preparation of summary memoranda and maintenance of screening lists

Experience

• Bachelor's degree in a scientific discipline
• Minimum 2 years of clinical research experience
• Experience in Opthalmology and/or Infectious Disease experience is desired
• 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

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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.

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.