Clinical Document Specialist I

4 weeks ago

india TransPerfect Full time
Do you work in clinical research and would like to explore more about different functionalities within this industry?

Never known TMF management could be a career option and want to know more?

Do you want to expand your horizon and learn something more than you currently know?

Do you want to learn from the experts and apply your knowledge in your day to day work?

Are you passionate about what you do and want to be part of an organization that nurtures talent and provides growth opportunities?

If you answered yes to one or more of these, come explore some openings we have in our Clinical Document Services team at TransPerfect

Clinical Document Specialist (CDS I)

About the role:

As a Clinical Document Specialist I, you will be responsible for reviewing essential/ non-essential TMF documents for the assigned projects and ensure they are accurately filed at their desired location in the eTMF. This role requires attention to detail, understanding of regulations surrounding TMF management, sponsor expectations, inspection readiness and strong sense of timeline management. The role is strongly supported by line manager and a dedicated learning and development team that helps nurture your capabilities to succeed in your role.

Do you think you have what it takes to be a Clinical Document Specialist I? Check the role description below:

Responsibilities:

- Review documents in eTMF workflow to complete initial Indexing.- Ensure to sustain & improve quality thresholds and meet daily productivity goals as defined in organization SOPs.- Take pro-active steps to identify challenges and be able to suggest solutions.- Communicate efficiently and effectively with all stakeholders.- Keep study specific trackers up to date and communicate them to the Project Managers.- 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 User Acceptance Testing during product development and release.

Required Skills, Qualifications and Experience:

- 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.- Proficiency in Microsoft Office (Word, Excel, Outlook), knowledge of eClinical technologies is a plus.- Minimum bachelor’s degree or its equivalent.- Up to 1 year of experience in the Life Sciences industry.

Work Time: 9:30 AM - 6:30 PM (General Shift)

Work from Office is mandatory

Location - Aundh, Pune

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