Clinical Support Specialist

Why This Role Matters
The Clinical Support Specialist role at Syneos Health is a key position in clinical trial operations, ensuring that essential documentation, compliance, and study support activities are executed efficiently. This role directly contributes to the success of global clinical trials by maintaining Trial Master Files (TMF), supporting study teams, and ensuring adherence to ICH-GCP standards. It is an excellent opportunity for professionals looking to build a strong foundation in Clinical Operations and transition into advanced roles like Clinical Research Associate (CRA) or Clinical Trial Manager.

Job Description
As a Clinical Support Specialist, you will provide operational and administrative support to clinical study teams, focusing on TMF management, documentation quality control, and system maintenance. You will work closely with cross-functional teams to ensure clinical trial documentation is accurate, complete, and audit-ready. The role requires strong organizational skills, attention to detail, and the ability to manage multiple tasks in a dynamic clinical research environment.

Key Features of the Role:
Exposure to global clinical trial operations
Hands-on experience with TMF, QC, and study documentation
Opportunity to work in EMEA time zone projects
Strong career growth in Clinical Operations and CRO domain
Collaborative and learning-focused work environment

Responsibilities

• Maintain and manage Trial Master File (TMF) documentation
• Perform TMF filing, tracking, and quality control (QC) activities
• Conduct TMF completeness reviews and ensure audit readiness
• Support study maintenance activities and documentation workflows
• Maintain clinical applications and core systems used in trials
• Coordinate with study teams for task updates and deliverables
• Assist in site contract documentation and related processes
• Ensure compliance with SOPs, WIs, ICH-GCP, and regulatory guidelines
• Support central clinical operations team with assigned tasks
• Identify process improvements and implement best practices
• Maintain quality, performance, and compliance metrics

Required Qualifications
Candidates should have a basic understanding of clinical research processes along with strong administrative and documentation skills.

Educational Requirements:
Life Sciences (B.Pharm, M.Pharm, BSc, MSc) or equivalent
Associate degree with relevant clinical/administrative experience may also be considered

Experience and Skills:
• Minimum 1–2 years of experience in clinical research or similar role
• Hands-on experience in TMF filing, QC, and site contract support
• Familiarity with electronic TMF (eTMF) systems
• Strong communication and interpersonal skills
• Proficiency in MS Office (Word, Excel, PowerPoint, Outlook)
• High attention to detail and accuracy
• Ability to manage multiple tasks and meet deadlines
• Flexibility to work in EMEA time zone

Preferred Skills:
• Knowledge of ICH-GCP guidelines
• Exposure to clinical trial documentation and audit processes
• Experience working in CRO or pharma environment
• Ability to collaborate across global teams

Salary Insights:
Estimated Salary Range: ₹4 LPA – ₹7 LPA
Salary may vary based on experience and skillset

Company Overview
Syneos Health is a leading fully integrated biopharmaceutical solutions organization that supports customers across the entire drug development lifecycle. With a presence in multiple countries and a strong reputation in clinical research and commercialization, Syneos Health collaborates with pharmaceutical and biotech companies to accelerate the delivery of therapies to patients. The company is known for its innovative approach, strong client partnerships, and commitment to employee growth and development.

FAQs

What does a Clinical Support Specialist do?
They support clinical trials by managing documentation, maintaining TMF, and ensuring compliance with regulatory standards.

Is TMF experience mandatory?
Yes, hands-on experience with TMF filing and QC is important for this role.

What is eTMF?
Electronic Trial Master File (eTMF) is a digital system used to store and manage clinical trial documents.

What career growth can I expect?
You can progress to roles like Clinical Trial Associate (CTA), CRA, or Clinical Project Coordinator.

Is this role shift-based?
Yes, flexibility to work in EMEA time zone is required.

Application Tips
Highlight your TMF, QC, and clinical documentation experience
Mention familiarity with eTMF systems and clinical tools
Showcase your knowledge of ICH-GCP guidelines
Emphasize multitasking, time management, and communication skills
Prepare for questions on TMF structure, compliance, and audit readiness