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Clinical Trial Specialist

1 month ago

Cambridge, Massachusetts, United States Proclinical Staffing Full time
Job Title: Drug Safety Specialist

Proclinical Staffing is seeking a skilled Drug Safety Specialist to join our team in Cambridge, MA.

Job Summary:

The successful candidate will support the Case Management and Vendor Oversight (CMVO) team by managing documentation, assisting with regulatory responses, and participating in quality control processes.

Key Responsibilities:
  • Manage documentation and assist with regulatory responses to ensure compliance with regulatory requirements.
  • Participate in quality control processes to ensure accuracy and completeness of documents.
  • Maintain and archive documentation in the eTMF to ensure inspection readiness.
  • Collaborate with the Global Safety Systems team to support configuration of requirements and reporting rules.
  • Collect and compile metrics and KPIs for clinical trial safety case processing activities.
Requirements:
  • Strong organizational and documentation management skills.
  • Ability to support regulatory responses and participate in quality control processes.
  • Experience with inspection readiness and maintaining archive sites.
  • Proficiency in collaborating with global teams and supporting system configurations.
  • Capability to collect and compile metrics and KPIs for safety case processing.
About Proclinical Staffing:

Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

We are an equal opportunity employer and welcome applications from qualified candidates.