
Senior Clinical Document Specialist
3 days ago
About this position:
We are seeking a highly skilled Clinical Study Researcher and Medical Writer to develop high-quality clinical trial documents, translate complex scientific data into clear regulatory compliant documents, and craft abstracts and manuscripts.
Key Responsibilities:
- Developing high-quality key clinical trial documents, including protocols, Investigator's Brochures (IBs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), and Clinical Study Reports (CSRs).
- Translating complex scientific data into clear, regulatory compliant documents that support drug development and approval processes.
- Crafting abstracts and manuscripts, demonstrating strong scientific communication skills.
- Preparing protocols, CSRs, PIS-ICFs, and CRFs.
- Understanding study objectives and designing protocols.
- Preparation and review of SOPs.
- Communicating with stakeholders to ensure effective and complete documentation within the timeline.
Requirements:
- Proficient in developing high-quality clinical trial documents.
- Strong scientific communication skills.
- Ability to translate complex scientific data into clear regulatory compliant documents.
Benefits:
- A dynamic work environment.
- Opportunities for professional growth and development.
- A competitive salary and benefits package.
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