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.
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.
Provide regulatory guidance throughout the clinical development lifecycle and prepare quality regulatory submissions.
Compile, coordinate, and review applications to regulatory authorities, including CTA/IND and amendments.
Represent Global Regulatory Affairs at project team and business development meetings, overseeing Regulatory Affairs Specialists.
Precision Medicine Group is a life sciences company providing clinical research, regulatory, and commercial services to biopharmaceutical clients. It fosters a collaborative, quality-focused culture and is an Equal Opportunity Employer.
Support study execution by managing meeting logistics, documenting decisions, and tracking action items.
Partner with Clinical Operations and site monitors to ensure protocol compliance and quality standards.
Responsible for filing site-level documents into Trial Master Files and assisting with regulatory submissions.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into therapies for central nervous system disorders. As a small, mission-driven team, we foster a collaborative culture built on trust, ownership, curiosity, and results.