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Clinical Document Specialist II
1 month ago
We are seeking a highly skilled Clinical Document Specialist II to join our team. As a key member of our Clinical Operations group, you will be responsible for ensuring the quality and accuracy of clinical documents in our electronic Trial Master File (eTMF).
Key Responsibilities:
- Review and finalize the indexing of documents in the eTMF workflow.
- Ensure high-quality thresholds are met and daily productivity goals are achieved as defined in our organization's SOPs.
- Identify and address mis-filings, providing feedback to the indexing team to prevent repetition.
- Respond to project-related queries in project rooms, ensuring timely completion.
- Drive effective communication with stakeholders and coordinate with Clinical Document Team Leads.
- Perform internal reviews of assigned eTMFs, taking corrective action as needed for audit readiness.
- Assist with User Acceptance Testing during product development and release.
Requirements:
- Knowledge of clinical development phases and processes, including GCP and ICH regulations.
- Superior written and spoken communication skills in English.
- Proficiency in Microsoft Office (Word, Excel, Outlook) and eClinical technologies.
- Document Management skills, including Adobe Professional and knowledge of scanning and document indexing.
- Minimum Bachelor's Degree from a 4-year college or equivalent.
- Minimum of 2.5 years of experience in the Life Sciences industry, with experience in essential documents and study documentation.
- Experience with clinical trials at research sites, IRB submissions, and pharmacovigilance is a plus.
Desired Skills and Experience:
- Previous employment in Pharmaceutical, CRO, Medical Device, or Investigative Site.
- Able to multitask in a fast-paced environment.
- Work seamlessly with people from diverse backgrounds and cultures.
- Build trust relationships with clients and colleagues.
- Work independently and as part of a team.
- Take proactive measures to solve problems and commit to high service standards.
Work Environment:
We offer a dynamic work environment with a strong support system, including a dedicated learning and development team. Our team is committed to nurturing your capabilities and helping you succeed in your role.
