Sr Clinical Operation Specialist (Cta , Client Based - Mumbai Location))

0-2 years

Not Disclosed

Mumbai

10 Nov. 3, 2025

Job Description

Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title:

Senior Clinical Operations Specialist (CTA, Client-Based – Mumbai Location)

Updated: October 24, 2025
Location: India – Client Site (Mumbai)
Job ID: 25102667

About Syneos Health

Syneos Health® is a fully integrated biopharmaceutical solutions organization committed to accelerating customer success. With a presence across 110 countries and a workforce of 29,000+ employees, we bring together clinical, medical, and commercial insights to drive impactful outcomes.

At Syneos Health, our Clinical Development model places the customer and the patient at the center of everything we do. We continuously strive to simplify processes, foster innovation, and create an environment that’s easy to work with — and easy to work for.

Work Here Matters Everywhere.

Why Syneos Health

Strong focus on career development, progression, and technical training.
Supportive, engaged line management and peer recognition programs.
Commitment to a “Total Self” culture, where authenticity and inclusivity thrive.
A workplace built on diversity of thought, culture, and background — ensuring everyone belongs.

Role Summary

The Senior Clinical Operations Specialist is a detail-oriented and process-driven professional responsible for managing PSDS/MAP programs and regulatory submissions related to Medical Affairs studies. The role requires strong collaboration with internal stakeholders (Medical Leads, Study Managers, Regulatory Affairs, Patient Safety) and external partners (CROs, vendors, physicians).

Responsibilities also include drug supply management, document control, and ensuring regulatory compliance across all assigned programs.

Key Responsibilities

1. PSDS / MAP Management

Create and manage user/physician accounts in the GEMS system for PSDS/MAP submissions.
Review and assess requests; coordinate with CMR/GMR for approvals.
Draft and finalize MAP/PSDS agreements and share documents with physicians.
Coordinate with physicians and supply teams for approvals and drug logistics.
Generate institute codes for supply logistics and maintain document archives in GEMS.
Provide training and guidance to physicians and internal teams on PSDS/MAP processes.
Collaborate with global teams on drug forecasting and attend study update meetings.

2. Local Medical Affairs (MA) Studies – Interventional, Non-Interventional, Research Collaborations

Manage end-to-end CTRI submissions and handle communication with CTRI authorities.
Coordinate with Regulatory teams for local submissions (QSR, DCGI dossiers).
Liaise with CROs for study documentation and activities.
Support self-assessment and compliance activities.
Handle local drug conversion processes (Drug Conversion Forms).
Coordinate with supply teams and trial sites for logistical needs.
Maintain and archive study documents in Subway/NCV repositories and ensure regulatory compliance.

3. Financial and Vendor Coordination

Review and process invoices related to medical affairs activities.
Support publication activities in coordination with physicians and vendors.
Assist with vendor onboarding, qualification, and agreement finalization.

Key Skills Required

Clinical Trial Operations
Medical Operations & Regulatory Management
Documentation & Archival Management
Clinical Trial Systems Proficiency
Cross-functional Coordination
Excellent Communication & Organizational Skills

Core Focus Areas (S11 Level)

Safeguarding the wellbeing of research subjects.
Reviewing and executing study protocols per global and local regulatory standards.
Coordinating communication with clinical trial volunteers and investigators.
Monitoring trial progress and resolving operational issues.
Collaborating with cross-functional teams to develop study materials.
Ensuring compliance with health, safety, and quality systems.

Impact & Contribution

Roles at the S11 level are central to ensuring safe, compliant, and effective execution of clinical research. These professionals uphold the integrity of trials, safeguard participant wellbeing, and drive timely study progression through seamless coordination, documentation, and operational excellence.

Additional Information

Duties listed are not exhaustive; the company may assign additional responsibilities as needed.
Equivalent combinations of experience, education, or skills will be considered.
The company ensures full compliance with Equal Opportunity and Disability Accommodation laws globally.

About Syneos Health (Quick Facts)

Partnered in 94% of all FDA-approved novel drugs in the last five years.
Contributed to 95% of EMA-authorized products.
Supported 200+ studies across 73,000 sites and 675,000+ trial patients.

Learn more: www.syneoshealth.com

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Sr Clinical Operation Specialist (Cta , Client Based - Mumbai Location))

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