Clinical Trial Associate II Job in Bengaluru at Premier Research with hybrid work for experienced clinical research professionals in global trial operations.
Introduction
An excellent opportunity is available for experienced clinical research professionals looking to advance their career in global clinical trial operations. The Clinical Trial Associate II role offers deeper involvement in trial documentation, systems management, and cross-functional coordination. This position is well-suited for candidates who already have hands-on exposure to clinical studies and want to contribute to high-quality, compliant clinical research while working in a flexible hybrid environment. Clinical Trial Associate II Job in Bengaluru
Company Overview
Premier Research is a global clinical research organization that partners with biotechnology, medical device, and specialty pharmaceutical companies. The organization supports the development of innovative medicines, diagnostics, and medical technologies that address critical patient needs. Premier Research is known for its people-first culture, commitment to quality, and focus on professional growth through continuous learning and collaboration. Clinical Trial Associate II Job in Bengaluru
Job Location & Employment Type
- Job Location: Bengaluru, India
- Work Scope: India
- Employment Type: Full-time
- Work Mode: Hybrid
Open Positions / Department Details
- Position Title: Clinical Trial Associate II
- Department: Global Clinical Monitoring and Site Management
- Job Requisition ID: R5940
- Career Level: Experienced / Mid-Level
This role provides advanced support to clinical study teams and may include mentoring responsibilities for junior team members. Clinical Trial Associate II Job in Bengaluru
Key Roles & Responsibilities
Document Management Responsibilities
The Clinical Trial Associate II plays a critical role in maintaining the integrity, quality, and compliance of clinical trial documentation.
Key responsibilities include:
- Managing Trial Master File (TMF) and electronic TMF (eTMF) activities in accordance with sponsor SOPs and regulatory requirements
- Creating, updating, and maintaining TMF placeholders based on filing plans, study milestones, document expiration, and site staff changes
- Reviewing essential site documents to ensure alignment with company standards, sponsor expectations, regulatory authority requirements, and ALCOA+ principles
- Performing quality reviews and completeness checks of assigned eTMF sections during study start-up, conduct, and close-out
- Following up with internal clinical teams to ensure timely resolution of TMF findings and queries
- Generating, reviewing, and distributing eTMF reports to support ongoing quality and inspection readiness
- Supporting Site Start-Up Associates and CRAs with essential document collection and review
- Assisting with translation coordination or review of translated site documents when required
Clinical Trial Associate II Job in Bengaluru
Data Entry, Tracking, Reporting & System Support
This role requires advanced involvement in clinical systems and study-level tracking activities. Clinical Trial Associate II Job in Bengaluru
Responsibilities include:
- Supporting CTMS setup and maintaining accurate project data including site contacts, addresses, assignments, and activation details
- Tracking and documenting distribution of Investigator’s Brochure, safety reports, and other study-related communications sent to sites
- Managing and monitoring system access for site staff and study teams across platforms such as CTMS, eTMF, EDC, IWRS, and vendor systems
- Conducting routine system access reviews to ensure compliance and timely access removal
- Reviewing study-specific training matrices and compliance reports for clinical team members
- Creating and maintaining CRA workflows to track site follow-up activities and action items
Additional Clinical and Operational Support
- Attending internal clinical meetings and supporting preparation of agendas, action logs, and follow-up items
- Coordinating with third-party vendors to resolve issues related to study equipment, translations, or operational support
- Supporting study-specific tracking tools such as Q&A logs and issue trackers
- Assisting in the preparation of Investigator Site Files and Pharmacy Files prior to Site Initiation Visits
- Coordinating with vendors for creation, review, and distribution of Investigator Site File binders
- Supporting general administrative and logistical activities as requested
- Participating in internal training programs to enhance therapeutic and regulatory knowledge
- Mentoring and training junior Clinical Trial Associates when required
- Acting as a point of contact for basic IT or system-related issue resolution
- Identifying, managing, and escalating study-related issues in collaboration with the project team and line manager
- Participating in departmental initiatives and continuous improvement activities
- Performing additional study-related duties as assigned
Clinical Trial Associate II Job in Bengaluru
Eligibility Criteria
Education
Candidates must have:
- An undergraduate degree or international equivalent in:
- Life Sciences
- Nursing
- Medical Documentation
- Other relevant healthcare or clinical research disciplines
Experience
- Minimum 1 year of prior experience as a Clinical Trial Associate or in a similar clinical research support role
- An equivalent combination of education and relevant experience may be considered
Skills Required
- Fluent verbal and written communication skills in English
- Working knowledge of ICH-GCP guidelines
- Understanding of essential clinical trial documents and ALCOA+ principles
- Hands-on experience with clinical research systems such as CTMS and eTMF
- Proficiency in MS Word, Excel, PowerPoint, and Outlook
- Strong organizational and time-management skills
- Ability to meet deadlines in a fast-paced clinical research environment
- Excellent interpersonal and listening skills
- Capability to work independently as well as collaboratively within global teams
Clinical Trial Associate II Job in Bengaluru
Salary & Benefits
- Salary: As per company norms
Additional benefits may include:
- Stable full-time employment
- Hybrid work flexibility
- Exposure to global clinical trial projects
- Career progression opportunities within clinical operations
- Access to internal training and professional development programs
- Supportive and inclusive work culture
Selection Process
The selection process may include:
- Application screening
- Technical or role-specific interview
- Final HR discussion
Only shortlisted candidates will be contacted by the employer.
How to Apply
- Mode of Application: Online Application
Eligible candidates should apply through the official application link provided by the employer.
Important Dates
- Last Date to Apply: February 7, 2026
Candidates are advised to apply promptly as the application window is limited.
Why Apply for This Pharma Job?
This role is ideal for clinical research professionals who want to move beyond entry-level responsibilities and take ownership of trial documentation and systems management. With opportunities to mentor junior staff, collaborate with global teams, and work in a hybrid model, this position supports both professional growth and work-life balance in the clinical research domain. Clinical Trial Associate II Job in Bengaluru
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform and is not affiliated with Premier Research or any organization. All job details are provided for informational purposes only. Candidates should verify information through official employer communication before applying. Clinical Trial Associate II Job in Bengaluru
Final Call-to-Action
If you have prior clinical trial experience and are ready to take the next step in your clinical research career, apply now. Clinical Trial Associate II Job in Bengaluru
