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Clinical Trials Specialist

2 maanden geleden

Schiphol, Nederland Allucent Voltijd
Local Start-Up Specialist II

At Allucent, we are dedicated to helping small-medium biopharmaceutical companies navigate the complex world of clinical trials to bring life-changing therapies to patients worldwide.

We are seeking a highly skilled Local Start-Up Specialist II to join our team. This role will coordinate and perform local site start-up activities, executing essential document collection, regulatory authority submissions, and independent ethics committee approvals.

The successful candidate will be a member of our Study Start-up & Site Intelligence Unit, responsible for:

  • Tracking relevant information, data, progress, and milestones in CTMS and other tracking tools.
  • Ensuring planned dates are reliable and up to date in CTMS departments/study teams.
  • Filing documents in the (e)TMF for which they are the document owner.
  • Assisting other Study Start-up team members with filing documents in the (e)TMF.
  • Preparing, compiling, submitting, and maintaining regulatory documentation required by regulatory agencies.
  • Providing relevant documents in compliance with local regulations.
  • Supporting review of technical, pre-clinical, and clinical reports for regulatory submissions.
  • Interacting with regulatory authorities.
  • Preparing and compiling answers for questions raised by regulatory agencies.
  • Regularly checking for updates on regulations, guidelines, and procedures.

Requirements

To be successful, you will possess:

  • A Life Science degree or equivalent qualification or certification in a related allied health profession.
  • 2+ years of experience in regulatory affairs in the pharmaceutical or biotechnology industry.
  • A thorough knowledge of country or region competent authority submission and reporting requirements and guidelines.
  • A thorough understanding of the drug development process.
  • Good oral and written communications skills - fluent in English and either Dutch or French.
  • Attention to detail.
  • Able to perform well as a team member.

Benefits

Benefits of working at Allucent include:

  • Comprehensive benefits package.
  • Competitive salaries per location.
  • Departmental Study/Training Budget for furthering professional development.
  • Flexible Working hours (within reason).
  • Opportunity for fully remote working or hybrid Working Model.
  • Leadership and mentoring opportunities.
  • Internal growth opportunities and career progression.
  • More task variety.
  • Financially rewarding internal Employee Referral Program.
  • Access to online soft-skills and technical training via GoodHabitz and internal platforms.