Senior Tmf Classifier

2+ years

Not Disclosed

Bangalore

10 March 19, 2025

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: eTMF Document Classification Specialist
Company: [Company Name]
Location: [Insert Location]

Job Overview:

We are seeking an eTMF Document Classification Specialist to manage document classification under Smart Inbox and ARC review, along with document deletion for clinical studies. This role involves overseeing electronic Trial Master Files (eTMF) for clinical trials, ensuring compliance with regulatory requirements, and maintaining audit readiness. The successful candidate will work closely with key study personnel, ensuring the integrity of the eTMF system and delivering high-quality, compliant documents throughout the study phases.

Key Responsibilities:

Document Management & Classification:
- Manage electronic Trial Master Files (eTMF) for clinical studies, ensuring all Trial, Country, and Site artifacts are classified in accordance with TMF processes.
- Oversee document classification under Smart Inbox and ARC review, and handle document deletion as needed.
- Perform quality checks on e-documents prior to release, confirming image clarity, readability, and accuracy.
- Ensure all essential artifacts are processed and tracked in accordance with company SOPs, sponsor SOPs, GCP, and ICH guidelines.
Audit Readiness & Compliance:
- Maintain the eTMF in a state of audit readiness for quality and compliance.
- Conduct Audit Ready Checks on individual documents uploaded to the eTMF system to ensure proper context and adherence to regulatory requirements.
- Prepare the eTMF for QA or sponsor audits, including resolution of any issues and implementation of corrective actions as needed.
- Participate in internal and client audits as required.
Collaboration & Communication:
- Work closely with team members and stakeholders to identify operational issues and resolve TMF-related challenges.
- Ensure overall client satisfaction by providing high-quality eTMF management throughout the study lifecycle.
- Participate in business improvement initiatives aimed at enhancing quality, productivity, and continuous improvement of business processes.
- Attend internal and external study team meetings as needed and provide training/mentorship to colleagues as required.
Regulatory Knowledge & Training:
- Maintain up-to-date knowledge of applicable regulatory requirements related to TMF management and clinical trials.
- Provide training and mentorship to team members on best practices for eTMF management and compliance.

Qualifications (Minimum Required):

Education:
- Bachelor’s degree in Life Sciences, Business, or a related field.
Experience:
- 3 to 6 years of experience working in a clinical research environment.
- Clear understanding of GCP and ICH guidelines, as well as regulatory and clinical document requirements.
- Proficiency in Microsoft Office, web-based applications, Adobe Acrobat Standard, and related scanning software.
Skills:
- Excellent interpersonal and communication skills.
- Strong attention to detail and organizational skills.

Preferred Qualifications:

Education:
- Master’s degree in Life Sciences, Business, or a related field.
Experience:
- Experience working with clinical electronic systems.

Physical Demands/Work Environment:

Minimal travel (less than 10%) for sponsor kick-off meetings, face-to-face client meetings, or as requested.

EEO & Accommodations:

[Company Name] is committed to diversity and inclusion in the workforce and offers equal opportunities for employment. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, disability, or any other legally protected characteristic. We encourage all qualified individuals to apply.

For more information on how we collect and store your personal data, please refer to our Privacy Statement.

If you require accommodations during the application process due to a disability, please contact: [Contact Email].

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Senior Tmf Classifier

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