Manager, Monitoring & Site Management (US)

Alimentiv; Minneapolis (MN); Presencial; USD 111.000 - 174.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Education reimbursement

Cell phone allowance

Remote work allowance

Office setup allowance

Mentorship program

Descripción de la vacante

Alimentiv is a global CRO focused on GI therapies, seeking a Manager to lead Clinical Monitoring, overseeing teams, regulatory compliance, and project delivery. The role requires coordinating with sponsors and sites to maintain quality and timeliness across the lifecycle.

The position emphasizes staff development, process improvement, and collaboration across time zones, with remote/global work and a competitive benefits package.

Formación

• College diploma or university degree in a relevant field, preferably Health Sciences or Life Sciences; SoCRA and/or ACRP certification/designation is considered an asset.
• Minimum 4–6 years of relevant clinical research/clinical monitoring experience with substantial ongoing training.
• Demonstrated experience managing CRA or Clinical Monitoring staff, including performance management, resource planning and staff development.
• Proven ability to train, mentor and support colleagues in both one-to-one and team settings.
• Strong knowledge of ICH‑GCP, applicable clinical research regulations and guidelines, and clinical monitoring best practices.
• Demonstrated leadership skills with the ability to engage, develop and support high‑performing teams.
• Strong stakeholder management skills and a collaborative, customer‑focused and solution‑oriented approach.
• Strong verbal and written communication skills, with the ability to work effectively with internal teams, sponsors and external partners.
• Excellent organisational and prioritisation skills, with the ability to manage multiple responsibilities and deadlines in a dynamic environment.
• Ability to work effectively in a remote, global environment and collaborate across functions, geographies and time zones.

Responsabilidades

• Lead the day‑to‑day delivery of the Clinical Monitoring function, ensuring high-quality, timely and compliant services across assigned projects.
• Manage and develop Clinical Operations Leads, including resource planning, work allocation, training and development, employee engagement and performance management.
• Ensure appropriate staffing levels across projects, balancing operational requirements, team capacity and project priorities.
• Partner with clinical monitoring and project leadership to develop and oversee project‑specific strategies and processes relating to site selection, monitoring, ICH‑GCP compliance and global project delivery.
• Provide oversight and support for the identification, escalation and resolution of site, sponsor and clinical monitoring issues.
• Drive the development and continuous improvement of policies, procedures, tools and processes supporting Clinical Monitoring activities.
• Partner with internal stakeholders, sponsors and research sites to identify opportunities for improvement and support the implementation of new technologies and processes.
• Identify, engage and manage independent contractor resources, including recruitment, contract support, training, cost monitoring, compliance and performance management.
• Ensure Clinical Monitoring activities comply with applicable regulations, ICH‑GCP, organizational procedures and industry best practices.
• Provide Clinical Monitoring expertise to project teams and Business Development throughout the project lifecycle, from the bidding process through project delivery and reporting to sponsors.

Conocimientos

Clinical monitoring experience

Staff management

Regulatory knowledge

ICH-GCP knowledge

Stakeholder management

Communication skills

Leadership

Organisational skills

Remote collaboration

Educación

Health Sciences degree

Descripción del empleo

Alimentiv is a global CRO with a singular focus: advancing therapies for patients with gastrointestinal diseases. GI is our WHY and for more than 30 years that purpose has driven our scientific rigour, operational excellence, and deep therapeutic expertise, including supporting more than 70% of IBD compounds in development.
We operate as a private, profit-with-purpose company, channeling our commercial success back into scientific research, technology, and our people. With approximately 700 people across multiple countries and three service lines, we are growing deliberately, and the capability of our leaders and our organization is central to how we get there.

If you want to do meaningful work, build something real, and invest back in research that changes lives — we want to meet you!

Job Overview

The Manager, Monitoring & Site Management is responsible for the day‑to‑day leadership and delivery of the Clinical Monitoring function, with responsibility for Clinical Operations Leads and associated contractor resources. This role oversees resource planning, staff development and performance, clinical monitoring quality, regulatory compliance, process improvement and operational delivery.

Working closely with project teams, sponsors and internal stakeholders, the Manager provides clinical monitoring expertise throughout the project lifecycle and ensures services are delivered to a high standard, on time and in accordance with regulatory requirements, industry best practices and organizational objectives.

Key Responsibilities

• Lead the day‑to‑day delivery of the Clinical Monitoring function, ensuring high-quality, timely and compliant services across assigned projects.

• Manage and develop Clinical Operations Leads, including resource planning, work allocation, training and development, employee engagement and performance management.

• Ensure appropriate staffing levels across projects, balancing operational requirements, team capacity and project priorities.

• Partner with clinical monitoring and project leadership to develop and oversee project‑specific strategies and processes relating to site selection, monitoring, ICH‑GCP compliance and global project delivery.

• Provide oversight and support for the identification, escalation and resolution of site, sponsor and clinical monitoring issues.

• Drive the development and continuous improvement of policies, procedures, tools and processes supporting Clinical Monitoring activities.

• Partner with internal stakeholders, sponsors and research sites to identify opportunities for improvement and support the implementation of new technologies and processes.

• Identify, engage and manage independent contractor resources, including recruitment, contract support, training, cost monitoring, compliance and performance management.

• Ensure Clinical Monitoring activities comply with applicable regulations, ICH‑GCP, organizational procedures and industry best practices.

• Provide Clinical Monitoring expertise to project teams and Business Development throughout the project lifecycle, from the bidding process through project delivery and reporting to sponsors.

Skills & Qualifications

• College diploma or university degree in a relevant field, preferably Health Sciences or Life Sciences; SoCRA and/or ACRP certification/designation is considered an asset.

• Minimum 4–6 years of relevant clinical research/clinical monitoring experience with substantial ongoing training.

• Demonstrated experience managing CRA or Clinical Monitoring staff, including performance management, resource planning and staff development.

• Proven ability to train, mentor and support colleagues in both one-to-one and team settings.

• Strong knowledge of ICH‑GCP, applicable clinical research regulations and guidelines, and clinical monitoring best practices.

• Demonstrated leadership skills with the ability to engage, develop and support high‑performing teams.

• Strong stakeholder management skills and a collaborative, customer‑focused and solution‑oriented approach.

• Strong verbal and written communication skills, with the ability to work effectively with internal teams, sponsors and external partners.

• Excellent organisational and prioritisation skills, with the ability to manage multiple responsibilities and deadlines in a dynamic environment.

• Ability to work effectively in a remote, global environment and collaborate across functions, geographies and time zones.

What We Offer

In addition, as an Alimentiv Employee, you’re also eligible for the following programs:

• Education Reimbursement program for full‑time employees
• Monthly Cell Phone and Remote Work Allowance (dependent on role eligibility)
• One time office setup allowance (can be used to purchase a scanner/printer, extra monitor, office furniture, etc.)
• Working while visiting program – up to 4 weeks per year!
• Flexible Summer Hours Program from May – September
• Employee referral incentive – we know great people know other great people, and we think that warrants recognition!
• Full‑time employees also become beneficiaries of the Alimentiv Trust after one year of employment, and permanent members after 5 years of employment
• Optional formal mentorship program (Alimentorship); country/region annual social events in person; leadership development programs for people leaders in accordance with your seniority; social committee and several other optional initiatives designed to support you in feeling like part of the Alimentiv team!

Additional benefits may be available depending on the country of employment and are subject to local policies and eligibility.

Our Services

• End-to-end GI clinical trial services, from protocol design through submission support
• Central medical imaging management and endoscopic reading
• Precision medicine and biomarker solutions
• Real‑world evidence and clinical consulting
• Histopathology and lab services through AcelaBio

Equal Opportunity and Accessibility

Alimentiv is committed to building a diverse, inclusive and respectful workplace. We are an equal opportunity employer and consider all qualified applicants for employment without regard to race, colour, ethnicity, national origin, religion or belief, sex, gender identity or expression, sexual orientation, age, marital or family status, disability, or any other characteristic protected by applicable law.

Accommodations are available upon request for persons with disabilities throughout the recruitment and selection process. Requests can be directed to [e-mail].

$110,500 - $174,000 a year

+ bonus