Clinical Document Specialist I

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.

• 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 bachelor’s 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 ([email protected])

Candidates with the required qualifications and experience are encouraged to apply.