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Role and Responsibilities:
- Coordinate all study start-up activities to achieve site activations, ensuring compliance with ICH-GCP and regulatory requirements.
- Serve as the primary point of contact for sponsors and internal teams, driving the start-up strategy and managing deliverables.
- Prepare and review regulatory submissions and essential documents, track progress, and ensure timely site initiation.
Qualifications:
- Bachelor's degree in Chemistry, Life Sciences, Nursing, or equivalent experience.
- Minimum 5 years within pharmaceutical/CRO industry with proven ability to manage multi-country projects in start-up.
Skills and Knowledge:
- Excellent organizational and management skills with strong planning and problem-solving abilities.
- Outstanding knowledge of ICH GCP and proficiency in MS Office applications.
Culture and Values:
- We are a collaborative international team with a focus on rare disease and oncology, offering flexibility and work-life balance.
- Our values include quality, integrity, drive, agility, belonging, and collaborative partnerships.
Ergomed
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.