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Clinical Document Specialist II
2 months ago
About the role:
As a Clinical Document Specialist II, you will be responsible for checking the quality of indexed documents in the eTMF and ensure they are filed correctly, with accurate metadata applied to each document. Occasionally, you may be assigned for more detailed eTMF quality review to ensure the eTMF is inspection ready. This role requires attention to detail, understanding of regulations surrounding TMF management, sponsor expectations, inspection readiness and strong sense of timeline management. In addition to that knowledge of global IRBs and Regulatory authorities and their requirements is expected. The role is strongly supported by line manager and a dedicated learning and development team that helps nurture your capabilities and succeed in your role.
Do you think you have what it takes to be a Clinical Document Specialist II? Check the role description below:
Responsibilities:
- Review documents in the workflow to finalize the indexing of the documents.
- Ensure to sustain & improve quality thresholds and meet daily productivity goals as defined in organization SOPs.
- Identify mis-filings and provide feedback to the indexing team, also to ensure the mis- filings are not repeated.
- Answer Q&As in project rooms and ensure they are completed within timelines.
- Drive efficient and effective communication with all stakeholders.
- Coordinate with Clinical Document Team Leads for project related queries, keeping various project documentation up to date and in line with client expectations.
- Perform internal reviews of assigned eTMFs and take corrective action as required for audit readiness.
- Assist with User Acceptance Testing during product development and release.
Required Qualifications, Skills and Experience:
- 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 knowledge of eClinical technologies.
- Proficiency in Document Management (Adobe professional, knowledge of scanning an advantage, document Indexing, using ISI Tools and Capture Perfect)
- Minimum Bachelor’s Degree from a 4-year college or equivalent.
- Minimum of 2.5 years of experience in the Life Sciences industry; Experience with essential documents and other study documentation.
- Experience with clinical trials at research sites, IRB submissions, 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 a variety of different backgrounds and cultures.
- Build trust relationships with clients and co-workers alike.
- Can work independently and as part of a team.
- Take proactive measures to solve problems and commit to a high level of service.
Work Time : 9:30 AM - 6:30 PM (General Shift)
*Work from Office is mandatory
Location - Aundh, Pune
If interested please send your resume to
