Centralized Monitor

Company Description

Medicine moves forward here. So will you.

Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications. We focus on the most complex trials, the studies where experience, judgement, and rigorous operational accountability make the biggest difference. We partner with small to midsize biotech companies to move promising therapies through early phase development, so they reach the patients sooner.

We choose complex work on purpose. Rare disease and oncology trials carry real operational risk, and our people are experts at reducing it, protecting timelines, data quality and the experience of sites and patients at the same time. It is demanding, meaningful work, and no one here forgets that patients cannot wait.

That is why culture matters to us as much as capability. We have built a collaborative, international team where people share ideas, grow their careers and are trusted to take ownership early. With colleagues across North America, South America, Europe, Asia and Australia, we value teamwork, flexibility and a real commitment to work-life balance, because good science comes from people who feel supported.

If you want work with purpose, the agility to make an impact and a team that cares about the people behind the work as much as the work itself, we would love to hear from you.

Job Description

• Performs review and analysis of centralized, aggregated data to identify potential signals and trends in predefined risk indicators.
• Supports the initial review of the Risk Assessment and Categorization Tool (RACT).
• Reviews outputs generated through the RBQM system and escalates identified findings as appropriate.
• Conducts periodic review of site-level Key Risk Indicators (KRIs).
• Monitors site performance and identifies potential issues requiring further review or corrective action.
• Reviews the effectiveness of implemented actions and escalates concerns when additional action may be required.
• Evaluates the quality and integrity of study site practices related to protocol compliance and applicable regulations based on centralized monitoring outputs.
• Maintains effective project-level communication with relevant stakeholders regarding centralized monitoring findings and follow-up activities.
• Maintains relevant project documentation and contributes to the development and maintenance of centralized monitoring documentation, as applicable.
• Attends study kick-off meetings, recurring project meetings and other relevant meetings according to project needs.
• Maintains knowledge of applicable company SOPs, processes and centralized monitoring requirements

Qualifications

• Education – BA/BS degree in a Life Science field, or equivalent education and experience in line with country-specific requirements
• Minimum of 1 year of experience in clinical research or a related field
• Understanding of Risk Based Quality Management and centralized monitoring principles.
• Working knowledge of applicable clinical research regulations, ICH-GCP principles
• Ability to review and interpret clinical study data, trends and risk indicators.
• Good analytical and problem-solving skills.
• Good written and verbal communication skills.
• Ability to work effectively within cross-functional study teams.
• Good organizational skills and ability to manage activities across assigned studies

Additional Information

When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.

We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.

• Quality: we hold ourselves to the standard patients deserve.
• Integrity and trust: we do the right thing, especially when it is hard.
• Drive and passion: we care about the outcome, because someone is waiting on it.
• Agility and responsiveness: we move quickly, because patients cannot wait.
• Belonging: everyone is welcome, and every voice counts.
• Collaborative partnerships: we go further by going together.

We look forward to welcoming your application.