
Clinical Operations Specialist
5 days ago
We are seeking an experienced Clinical Operations Specialist to join our team. The ideal candidate will have a strong background in clinical trial management and medical monitoring.
The successful candidate will be responsible for:
- Medical Monitoring of Clinical Trials: Overseeing the medical monitoring of in-house clinical trials and ensuring that all necessary documents are up-to-date.
- Clinical Document Development: Developing and reviewing clinical documents, including protocols, investigator's brochures, case record forms, product rationales, and prescribing information.
Secondary Responsibilities
- Review of ICSRs and Aggregate Reports: Medical review of Individual Case Safety Reports (ICSRs) and aggregate reports, signal reports, and risk management plans.
- Clinical and Non-Clinical Overviews: Review of clinical and non-clinical overviews and summaries of the Common Technical Document (CTD).
- CT Waiver Applications: Review of medical rationale for CT waiver applications.
- New Product Evaluation: Evaluation of new products for development.
- Mentoring and Training: Mentoring and training team members to gain required skills to enable on-time deliverables.
To be considered for this role, you must have:
- A degree in a life science or related field.
- Experience in clinical trial management and medical monitoring.
- Strong communication and interpersonal skills.
- Ability to work independently and as part of a team.
We offer a competitive salary and benefits package, including:
- Opportunities for Professional Growth: We invest in our employees' professional development and provide opportunities for growth and advancement.
- Diverse and Inclusive Work Environment: We strive to create a diverse and inclusive work environment where everyone feels valued and respected.
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