"Project Associate I RA QA Job | ELEXES Medical Consulting Hiring Freshers | Pharma Duniya"

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"Project Associate I RA QA Job | ELEXES Medical Consulting Hiring Freshers | Pharma Duniya." (Project Associate I RA QA Job | ELEXES Medical Consulting Hiring Freshers) Introduction If you are a fresher or early-career professional aiming to build a strong career in Medical Device Regulatory Affairs and Quality Assurance , this opportunity can be a perfect starting point. ELEXES Medical Consulting Pvt. Ltd. has announced hiring for the position of Project Associate I – Regulatory Affairs & Quality Assurance (RA/QA) . This role is specially designed for fresh graduates and candidates with up to 6 months of experience who want hands-on exposure to global medical device regulations , including US FDA, EU MDR, CDSCO, Health Canada , along with ISO 13485 quality systems . The position offers real project experience under expert mentorship, making it ideal for long-term growth in the medical device regulatory domain. About The Company – ELEXES Medical Consulting Pvt. Ltd. EL...

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"Emerald Clinical Trials Hiring Clinical Trial Specialist in Bangalore (Hybrid) | CRO Jobs in India"

"Emerald Clinical Trials Hiring Clinical Trial Specialist in Bangalore (Hybrid) | CRO Jobs in India"






(Emerald Clinical Trials Hiring Clinical Trial Specialist)






Introduction

The clinical research industry is growing rapidly in India, and global Contract Research Organizations (CROs) are expanding their operations to tap into skilled professionals. One such reputed global CRO, Emerald Clinical Trials, is currently hiring for the position of Clinical Trial Specialist (CTS) in Bangalore with a hybrid working model.

This opportunity is especially suitable for candidates with 2–3 years of experience in clinical operations, TMF management, and site start-up activities, who are looking to grow their career in global clinical trials. In this detailed article, Pharma Duniya brings you complete information about the Emerald Clinical Trials CTS job, including company background, job role explanation, eligibility, salary, interview details, and application process.


About Emerald Clinical Trials (Company Introduction)

Emerald Clinical Trials is a global, full-service Contract Research Organization (CRO) known for delivering high-quality clinical research solutions across the globe. The company focuses on people-centric clinical trials, combining scientific excellence with operational efficiency.

Company Highlights:

  • Company Name: Emerald Clinical Trials

  • Founded: 2017

  • Headquarters: Singapore

  • Global Presence: Asia-Pacific, Europe, and North America

  • Employees: 500+ clinical research professionals worldwide

  • Therapeutic Expertise: Renal, Cardiometabolic, Oncology, Medical Devices

Emerald Clinical Trials supports biopharmaceutical and medical device companies by managing complex global clinical trials while maintaining strict regulatory compliance and ethical standards.


Job Overview Summary (Clinical Trial Specialist)

The Clinical Trial Specialist (CTS) role at Emerald Clinical Trials is part of the Clinical Operations team. This position plays a key role in Trial Master File (TMF) oversight, site start-up coordination, and clinical documentation quality control.

As a CTS, you will work closely with CRAs, Clinical Trial Managers, and Project Managers to ensure the smooth execution of clinical trials while meeting global regulatory requirements such as ICH-GCP.


Vacancy Details (Official)

  • Job Title: Clinical Trial Specialist (CTS)

  • Department: Clinical Operations

  • Company: Emerald Clinical Trials

  • Location: Bangalore, India

  • Work Mode: Hybrid

  • Employment Type: Full-Time

  • Industry: Contract Research Organization (CRO)

  • Experience Required: 2–3 Years


Job Role & Responsibility Explanation 

As a Clinical Trial Specialist, your primary responsibility is to support the operational backbone of clinical trials. You will ensure that essential documents are accurate, complete, and inspection-ready throughout the study lifecycle.

Key Responsibilities Explained:

  • Managing and maintaining Trial Master Files (TMF) in both electronic and physical formats

  • Uploading, reviewing, and quality-checking TMF documents

  • Acting as a TMF Quality Control reviewer and TMF Lead when required

  • Supporting end-of-study TMF reconciliation, QC, and archival

  • Assisting in audit preparation and regulatory inspection responses

  • Performing quality checks on clinical documents, emails, and site communications

  • Supporting CTMS data entry, tracking milestones, and investigator payments

  • Coordinating with CRAs, CTMs, and Project Managers during site start-up

  • Managing Essential Document Packets (EDPs) from investigator sites

  • Supporting IRB / IEC submissions (local and central)

  • Reviewing Informed Consent Forms (ICFs) including amendments

This role requires strong attention to detail, documentation skills, and a good understanding of clinical trial processes.


Eligibility Criteria (Official)

Mandatory Requirements:

  • 2–3 years of experience as a Clinical Trial Specialist (CTS)

  • Hands-on experience in TMF management and site start-up activities

Preferred Qualifications:

  • Bachelor’s or Master’s degree in:

    • Life Sciences

    • Pharmacy

    • Nursing

    • Health Sciences

  • Knowledge of ICH-GCP, regulatory guidelines, and ethical requirements

  • Familiarity with clinical trial documentation and medical terminology


Skills Required

To succeed in this role, candidates should have the following skills:

  • Strong knowledge of TMF processes and compliance

  • Understandthe ing of clinical trial lifecycle

  • Excellent documentation and organizational skills

  • Attention to ddetailand audit readiness mindset

  • Ability to work cross-functionally with global teams

  • Familiarity with CTMS systems

  • Good written and verbal communication skills

  • Ability to manage multiple tasks under timelines


Salary Estimate (Indicative)

₹6,50,000 – ₹9,50,000 per annum

The final salary will depend on:

  • Relevant experience

  • Technical skills

  • Interview performance

  • Internal company compensation structure

This salary range is competitive for mid-level CRO clinical operations roles in India.


Interview Details (Official)

  • Interview Mode: Virtual / Hybrid (as per company process)

  • Selection Process:

    • Resume Shortlisting

    • Technical Interview (Clinical Operations & TMF)

    • HR Discussion

Shortlisted candidates will be contacted directly by the Emerald Clinical Trials recruitment team.


Required Documents

Candidates should keep the following documents ready:

  • Updated Resume / CV

  • Educational Certificates

  • Experience Letters

  • Government ID Proof

  • Any relevant clinical training or certification documents


How to Apply

Interested and eligible candidates can apply online through the official Emerald Clinical Trials career portal:

πŸ”— Apply Here:
https://careers.emeraldclinical.com/jobs/7037664-clinical-trial-specialist?utm_source=LinkedIn


FAQs – Emerald Clinical Trials CTS Job

Q1. Is this a work-from-home job?
This is a hybrid role, combining office and remote work.

Q2. Is CRO experience mandatory?
Yes, prior experience as a Clinical Trial Specialist with TMF exposure is mandatory.

Q3. Can freshers apply for this role?
No, this role requires 2–3 years of CTS experience.

Q4. Is Emerald Clinical Trials a global company?
Yes, Emerald Clinical Trials operates globally with headquarters in Singapore.


Final Conclusion

The Clinical Trial Specialist job at Emerald Clinical Trials is an excellent opportunity for experienced clinical research professionals looking to advance their careers in a global CRO environment. With a hybrid work model, competitive salary, and exposure to international clinical trials, this role offers long-term growth and learning.

If you have solid TMF and site start-up experience and want to work with a reputed CRO, this position is worth applying for.

Note: Pharma Duniya does not charge any money for job information.
Candidates are advised to verify details from the official company website.


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