Senior Manager, Clinical Disclosure & EudraCT Submissions

Artech Information System LLC

East Hanover (NJ)

On-site

USD 100,000 - 130,000

Full time

14 days+

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Job summary

A leading IT staffing company in East Hanover is seeking a Senior Manager for Clinical Disclosure. The role requires over 10 years of clinical research experience and involves preparing submissions to the EMA's EudraCT platform. Candidates must have strong negotiation skills and the ability to work within complex team structures. This position is contract-based and offers the opportunity to influence clinical trial processes while ensuring compliance with EU regulations.

Qualifications

  • Minimum of 10 years clinical research and development experience.
  • Strong negotiation and conflict resolution skills are essential.
  • Ability to work across different cultures and teams.

Responsibilities

  • Prepare results for submission to the EMA's results website, EudraCT.
  • Circulate results for review by key clinical team members.
  • Assist with meeting the EU backlog for results submission.

Skills

Clinical research and development experience
Influencing within a cross-divisional matrix
Negotiation and conflict resolution skills
Planning and tracking skills

Education

Minimum Bachelor's degree in a scientific discipline

Job description

A leading IT staffing company in East Hanover is seeking a Senior Manager for Clinical Disclosure. The role requires over 10 years of clinical research experience and involves preparing submissions to the EMA's EudraCT platform. Candidates must have strong negotiation skills and the ability to work within complex team structures. This position is contract-based and offers the opportunity to influence clinical trial processes while ensuring compliance with EU regulations.
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