Manager, Study Start-Up and Regulatory Affairs

About the role

Ergomed is a specialist clinical research organisation focused on rare disease and select oncology indications, partnering with small to midsize biotech companies on early-phase trials. The Manager, Study Start-Up and Regulatory Affairs develops the strategy based on regulatory requirements and coordinates and oversees all study start-up deliverables from site selection through site initiation readiness. The role also supports senior management in securing new business and provides regulatory guidance, training and mentoring to junior staff.

Key responsibilities

• Lead study start-up and regulatory activities for medium to high complexity projects, ensuring delivery meets timelines, quality standards and regulatory requirements.
• Ensure end-to-end delivery of study start-up and regulatory milestones across assigned projects.
• Collect, review for completeness and compliance and track essential documents, investigating gaps and preparing reports on their status.
• Negotiate and execute clinical site agreements, ancillary agreements and amendments in line with project requirements and country regulations.
• Define and implement project-level study start-up and regulatory strategies aligned with sponsor expectations and operational feasibility.
• Identify, assess and mitigate risks affecting timelines and resolve issues promptly.
• Build relationships with clients, regulatory authorities and internal stakeholders.
• Monitor project budgets and hours, escalating overruns, and coach and mentor team members.
• Contribute to bids, regulatory sections of proposals, regulatory costing and budgets, and assist in winning new business.

Required profile

• Graduate degree in Chemistry or Life Sciences, Nursing or an equivalent combination of education and experience.
• 6-8 years in the pharmaceutical or CRO industry or a regulatory body, including at least 3 years in a leading or project management role.
• Proven ability to manage global projects.