Clinical Document Specialist I | Pune
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Job Summary
Job description
AsaClinicalDocumentSpecialistIyouwillberesponsibleforreviewingessential/.
DoyouthinkyouhavewhatittakestobeaClinicalDocumentSpecialistIChecktheroledescriptionbelow:
Job requirements
Responsibilities:
Review documents in eTMF workflow to complete initial Indexing.
Maintain defined quality standards and daily productivity goals as defined in organizational SOPs.
Take pro-active steps to identify challenges and be able to suggest solutions.
Communicate clearly and effectively with internal teams and stakeholders to support efficient document processing and issue resolution.
Keep study specific trackers up to date and communicate them to the appropriate stakeholders.
Coordinate with Clinical Document Team Leads for project related queries keeping various project documentation up to date and in line with client expectations.
Assist with UAT - User Acceptance Testing during product development and release.
Perform clinical document review other than eTMF as assigned.
Preferred Skills Qualifications and Experience:
Minimum 2 years of experience in clinical research including hands-on involvement in any of the: site management site start-up activities eISF Pharmacovigilance CTMS medical writing HIPAA compliance Regulatory Submissions Data Management or other related areas.
Knowledge of clinical development phases and processes including GCP and ICH regulations.
Knowledge of essential documents and other clinical study documentation.
Superior written and spoken communication skills in English.
Have an aptitude and positive approach to learning new systems and processes. Be curious to challenge the status quo.
Proficiency in Microsoft Office (Word Excel Outlook) knowledge of eClinical technologies is a plus.
Minimum bachelors degree or its equivalent.
Work Time: 9:30 AM - 6:30 PM (General Shift)
Work from Office is mandatory
Location - Aundh Pune
If interested please email your resume to Hritik Kale ()
Candidates with the required qualifications and experience are encouraged to apply.
- Pune Mahārāshtra India
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Required Experience:
IC
Key Skills
- DRG
- Acute Care
- Adobe Acrobat
- ICD-10
- Records Management
- Technical Writing
- Clinical Documentation Improvement
- Documentation Review
- Sharepoint
- cGMP
- Document Management Systems
- Document Management
About Company
TransPerfect Translations is a translation, E-Discovery and language services company based in New York City. The company serves clients in many fields, such as film, gaming, legal and healthcare fields. As of 2012, TransPerfect is "the largest privately owned language services provid ... View more
