Manager, Clinical Monitoring - Remote

Manager, Clinical Monitoring

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 Manager, Clinical Monitoring is responsible for the operational monitoring support activities, whether on-site or remote, for a protocol or group of protocols, overseeing monitoring timelines and the associated deliverables, including the monitoring plan, site visit reports, site selection, etc. In addition, the Manager, Clinical Monitoring works closely with internal project members to ensure compliance with the regulatory requirements, ICH guidelines, Standard Operating Procedures (SOPs), the study protocol, and overall research objectives. Travel between corporate locations or on co-monitoring/training visits may be required; up to 20%. Please note that positions that require travel for Emmes must be able to provide proof of being fully vaccinated.

Responsibilities

• Provides mentoring, guiding, and coaching for Clinical Research Associates (CRAs) and in-house CRAs on assigned projects
• Conducts and tracks project training as required on the project-specific training checklist
• Ensures study timelines and deliverables are met by Monitoring Services staff, including, but not limited to, development of the site monitoring pan, evaluation of the risk-based monitoring strategy, monitoring visit frequency, monitoring visit report submission/approval timelines, study data collection timelines, and submission of expense reports per the project SOW, Emmes SOPs, and the site monitoring plan (SMP) as applicable
• Develops project specific technical documents for us in the execution of project activities including, but not limited to, monitoring visit report templates, monitoring visit checklists, site feasibility, selection/activation and monitoring correspondence documents
• Evaluates current operational practices and recommends process improvements to ensure continued compliance with regulatory requirements
• Maintains metrics related to site assessments, feasibility and selection, site progress, and close out activities
• Contributes to client/sponsor reports and communications on deliverables
• Provides operational leadership to Monitoring Services staff and escalates issues to project leaders and Monitoring Services line managers as per established project and corporate requirements
• Oversees site visits to determine protocol and regulatory compliance and prepares required documentation
• Conducts detailed review of visit deliverables for compliance with the protocol SMP and required protocol procedures
• Utilizes applicable protocol reports and in compliance with the SMP; plans timing of, prioritizes, and assigns visits to CRAs assigned to the study
• Ensures that the professional monitoring activities of the study meet corresponding country regulatory requirements
• May conduct observational, training, and co-monitoring visits with CRAs

Experience

• Bachelor's degree, preferably in a scientific discipline, or equivalent work experience
• Ideally at least 3 years progressive Clinical Research experience, including as a CRA
  • Positions that require travel for Emmes must be able to provide proof of being fully vaccinated
    
• Personnel management and project leadership highly desired
• Strong technical/analytical skills to identify and solve problems and adaptable to a dynamic environment
• Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company
• Strong organizational skills in order to maintain a high level of productivity, innovation, and priority-setting in order to complete assignments on-time and on-budget
• High attention to detail required
• Expertise in regulatory obligations for a Clinical Research Associate and relevant ICH GCP guidelines
• Ability to work on complex or multiple projects and exercise critical thinking
• Self-starter who can work independently and a team player who can work cross functionally with limited oversight
• Knowledgeable in clinical research operations, including interpretation and implementation of country regulations/ICH guidelines, as required

Emmes only requires all US new hires in the following job categories to be fully vaccinated before their first day of employment: (i) Clinical Research Associates (CRAs), (ii) Associate CRAs, and (iii) all CRA line managers. All new hires may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing. Emmes complies with all applicable laws regarding reasonable accommodations or exemptions for religious, medical, or other legally protected reasons.

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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Emmes 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.