Study Start Up Specialist/Sr. Study Start Up Specialist

Ergomed

Remote regions

US

Benefits

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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.

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