Clinical Trial Specialist
4 days ago
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.
- 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.
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.
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