Job details
Job type full-time part-time
Full job description
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 innovationWe believe in the power of truth, so much so that we named our company emmes, which means truthThrough 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 curiosityWe 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 sitesThe 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.gOperations 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 ophthalmology, onocology, and/or infectious disease 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
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 programWe 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!
The emmes company, llc is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practicesAll 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.
