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Ergomed
Ergomed
2 open remote positions
Ergomed is a specialist clinical research organization focused on rare disease and oncology indications. With colleagues across North America, South America, Europe, Asia and Australia, we value teamwork, flexibility and a real commitment to work-life balance.
Open Positions
Coordinate and oversee all activities for site activations in accordance with contract, protocol, ICH-GCP, and regulatory requirements. Act as primary point of contact for Sponsor and internal stakeholders during study start-up, developing strategy and managing regulatory deliverables. Prepare, collect, review regulatory information for submissions and track essential documents to facilitate efficient site initiation and activation.
ICH GCP
Regulatory Submissions
MS Office
Organizational Skills
Drafting, negotiating, and executing clinical site and ancillary agreements in compliance with country regulations and project timelines. Tracking site contracting progress, providing clear rationales for delays, and escalating issues with contingency plans. Acting as a country-level subject matter expert on site contracts for internal and sponsor stakeholders.
Negotiation
Communication
Attention To Detail
Project Management
Regulatory Knowledge