QC Specialist (eTMF) – Bangalore, Karnataka
Company: eClinical Solutions
Location: Bangalore, Karnataka, India
Job Type: Full-time, Permanent
Experience Required: Fresher
About eClinical Solutions
eClinical Solutions is a global leader in clinical data services, supporting life sciences organizations in accelerating clinical development initiatives. Leveraging the elluminate Clinical Data Cloud, eClinical Solutions provides centralized access to clinical data, advanced analytics, and digital solutions that enable smarter, faster decision-making in clinical trials.
Role Overview
We are seeking a QC Specialist (eTMF) to join our Bangalore team. The QC Specialist ensures the accuracy, completeness, and compliance of the Trial Master File (TMF) — the central repository for essential clinical trial documents. This role is ideal for freshers with strong attention to detail, a passion for quality, and a desire to grow in clinical data management and regulatory compliance.
The QC Specialist will act as a subject matter expert in quality control, supporting TMF maintenance, audit readiness, and regulatory compliance.
Key Responsibilities
Conduct meticulous QC reviews of TMF documents to ensure completeness, accuracy, and alignment with TMF Plans, SOPs, and applicable regulations (ICH-GCP, FDA, EMA).
Verify that all required documents are filed correctly in the TMF and electronic TMF (eTMF) systems, ensuring accurate metadata and document indexing.
Identify discrepancies, missing documents, or deviations and communicate findings to stakeholders including study teams, clinical operations, data management, regulatory affairs, and CROs.
Maintain detailed QC records and monitor corrective actions to resolution.
Support TMF health reports and KPIs, ensuring the TMF is inspection-ready for internal and regulatory audits.
Collaborate in creating, maintaining, and updating study-specific TMF Plans and Indexes.
Contribute to process improvement initiatives for TMF systems and workflows.
Provide guidance and mentorship to junior QC specialists as required.
Ensure compliance with eClinical Solutions quality standards, regulations, and industry best practices.
Candidate Profile
Education:
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Computer Science, or related field.
Experience:
Fresher candidates with internship or academic exposure to clinical trials or TMF processes are encouraged to apply.
Skills & Knowledge:
Basic understanding of ICH-GCP guidelines, DIA TMF Reference Model, and clinical trial regulatory requirements (FDA, EMA).
Familiarity with electronic Trial Master File systems (e.g., Veeva, Trial Interactive) is an advantage.
Proficiency in MS Office applications (Word, Excel, PowerPoint).
Strong attention to detail, organizational skills, and ability to prioritize multiple tasks.
Excellent verbal and written communication skills.
Team player with a proactive approach to problem-solving and continuous learning.
Why Join eClinical Solutions
Gain hands-on experience in clinical trial document management and regulatory compliance.
Work with global teams on cutting-edge clinical data solutions.
Learn from industry experts and develop your career in clinical research and quality assurance.
Contribute to the success of clinical trials that impact patient care worldwide.
Apply Now to join eClinical Solutions and begin your career in clinical data management and TMF quality assurance!
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