Clinical Trial Associate II

BANGALORE (IN)HYBRIDPOSTED: 8/12/2026
PHARMAFull-time
HIRING ORGANIZATIONPREMIER RESEARCHContract Research Organization / Clinical Research
Premier Research

ROLE DEFINITION & RESPONSIBILITIES

Maintain the Trial Master File (TMF/eTMF) in accordance with sponsor SOPs and regulatory requirements.
Create and maintain TMF placeholders based on study plans, milestones, and site staff changes.
Review site documents for quality and completeness following ALCOA+ and regulatory standards.
Perform routine quality reviews and completeness checks across study startup, maintenance, and close-out phases.
Follow up with internal clinical teams to resolve eTMF queries and missing document findings.
Generate and distribute eTMF tracking reports to facilitate compliance and assist with essential document collection.

REQUIRED VERIFIED SKILLS

eTMF
CTMS
TMF Management
ICH-GCP
ALCOA+ Principles
Essential Documents
Clinical Research

COMPENSATION & REWARDS

Salary: Competitive / Disclosed upon candidate shortlisting

ORGANIZATION CONTEXT & CULTURE

Premier Research is actively hiring for this position.

INDUSTRY: Contract Research Organization / Clinical Research
RECOMMENDED TRAINING
1/5

READY TO SUBMIT?

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