Manager, Monitoring & Site Management

About Alimentiv

Alimentiv is a global contract research organization (CRO) dedicated to advancing therapies for patients with gastrointestinal diseases. With over 30 years of experience, Alimentiv has supported more than 70% of inflammatory bowel disease compounds in development, driven by rigorous science, operational excellence, and specialized therapeutic knowledge. The company operates as a private, profit-with-purpose entity reinvesting commercial success into research, technology, and employee development. With around 700 staff across several countries and three service lines, Alimentiv is progressively growing, emphasizing leadership capabilities and organizational strength.

Job Opportunity

The role involves leading the daily operations of the Clinical Monitoring function, focusing on European Clinical Research Associates (CRAs). This position provides structure, transparency, and accountability to project management, planning, and ongoing improvement of this vital department.

Responsibilities span operational leadership and strategic influence, including shaping policies, enhancing processes, and guaranteeing the clinical work's quality and integrity aligns with regulatory requirements and industry standards. The role includes overseeing resource allocation, managing team performance, and maintaining compliance to achieve high standards consistently.

Collaborating closely with sponsors and research partners, you will represent the clinical monitoring and project teams throughout the entire study lifecycle, providing expertise and practical solutions. This position is open to one candidate residing in Germany, the UK, Ireland, Poland, Hungary, or Romania.

Key Responsibilities

• Collaborate with clinical monitoring and project leadership to develop, plan, and monitor processes related to site selection, clinical monitoring, ICH-GCP compliance resolution, and global project harmonization, including SOP and QS documentation upkeep and periodic site visits.
• Work with IT support to ensure sponsor requirements are met promptly.
• Act as liaison to internal teams and external sponsors, identifying improvement areas, resolving concerns, and integrating new technologies and processes within clinical monitoring.
• Guarantee compliance with regulatory standards, best industry practices, and organizational goals.
• Lead Clinical Monitoring teams by managing staffing, workload distribution, resource planning, training, technology adoption, process improvement, expense control, employee engagement, and performance evaluation including development and corrective actions.
• Manage independent contractor services for Clinical Monitoring, including assessing needs, recruitment, negotiating contracts, compliance with corporate and sponsor policies, training, cost control, and performance oversight to meet all service level agreements and regulatory guidelines.
• Develop tools and expertise to support project teams and business development in clinical, site, and compliance monitoring throughout the project lifecycle—from bidding to sponsor reporting.

Qualifications & Experience

• College diploma or university degree in relevant fields such as Health or Life Sciences, or professional certifications like SoCRA or ACRP.
• Minimum 4 to 6 years of related clinical monitoring experience, supplemented by continuous training.
• Proven experience managing CRA staff, providing training or mentorship individually or in group settings.
• Capability to work effectively in a remote, globally distributed environment.
• In-depth knowledge of clinical monitoring regulations and Good Clinical Practice (GCP) guidelines.
• Collaborative team player with a customer-focused and solution-oriented approach.
• Strong leadership qualities and excellent verbal, written, and organizational communication skills.
• Ability to multitask and meet deadlines in a fast-paced environment.

Working Conditions

The position is home-based.

Additional Information

Alimentiv has issued a phishing scam warning advising candidates to verify email communications, which always originate from "@alimentiv.com" addresses. Suspected scams should be reported to local cyber authorities.

The company utilizes AI tools to support parts of the recruitment process such as application review and response analysis; however, final hiring decisions are made by humans. Candidates may request more detail on data processing policies.

A bonus is part of the compensation package. The stated salary range reflects compensation for candidates located in Germany, with specific local packages discussed during interviews.