Senior Specialist Study Start Up & Regulatory Affairs

Senior Specialist Study Start Up & Regulatory Affairs

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.

The Senior Specialist, Study Start Up and Regulatory Affairs leads and coordinates all activities related to achieving site initiation readiness. The role provides subject matter expertise, ensures regulatory compliance, and serves as a key liaison between internal teams, clients, and external stakeholders.

ROLE AND RESPONSIBILITIES

• Accountable for delivery of assigned study start-up and regulatory milestones within defined scope.
• Make independent decisions within assigned scope regarding regulatory processes and documentation approaches.
• Handles medium-complexity regulatory environments, including multi-country requirements where applicable.
• Leads study start-up and regulatory activities for assigned countries or projects of medium complexity, ensuring delivery in line with timelines, quality standards, and regulatory requirements.
• Leads preparation, review, and quality control of regulatory and study start-up documentation (including submissions, essential documents, and translations) to ensure completeness, accuracy, and compliance with ICH-GCP and country-specific requirements.
• Responsible for drafting, negotiating, finalizing, and executing clinical site agreements, ancillary agreements as well as amendments at country or regional level, in accordance with project requirements and country regulations and within the projected delivery timelines.
• May collaborate with internal and external legal, finance and clinical operations department including communicating and explaining legal and budgetary issues in relation to countries of assignment.
• Responsible for site outreach in assigned country/countries; point of contact for site, sharing of non-confidential and confidential study information and management of confidential disclosure agreements.
• Coordinate with study teams, sponsors, clinical monitoring, clinical contracts and/or other functional areas on the priority and processing of documents leading to investigational product release, site activation readiness. Review all relevant documentation e.g. labels, patient information sheets, diary cards, insurance etc, to ensure compliance with ICH GCP & country specific requirements.
• Contribute towards the preparation and/or review of complex technical/scientific/legal documentation.
• Arrange for and/or review translation of essential documents as required
• Pro…