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

3-5 years

Not Disclosed

Mumbai

10 Nov. 5, 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

Position: Sr. Clinical Operations Specialist (CTA, Client-based – Mumbai Location)

Updated: October 24, 2025
Location: IND – Client (Mumbai)
Job ID: 25102667
Company: Syneos Health®

About Syneos Health

Syneos Health® is a fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. The company combines clinical, medical affairs, and commercial insights to deliver outcomes that address modern healthcare challenges.

With a Clinical Development model that places both the customer and patient at the center, Syneos Health continually simplifies and streamlines operations to make the organization easier to work with — and work for.

Work Here Matters Everywhere.

Why Join Syneos Health

Continuous career development, growth, and progression opportunities.
Supportive, engaged line management and mentorship.
Access to technical and therapeutic area training.
Recognition through peer rewards and a total rewards program.
A Total Self culture that values authenticity and inclusion.
Commitment to diversity, belonging, and global collaboration.

Role Overview

The Sr. Clinical Operations Specialist (CTA) is responsible for end-to-end management of PSDS/MAP programs, including regulatory submissions for medical affairs studies, vendor coordination, drug supply management, and documentation.

This role involves close collaboration with internal teams (Medical Leads, Regulatory Affairs, Patient Safety, Study Managers) and external stakeholders (CROs, vendors, and physicians) to ensure compliance, operational excellence, and smooth execution of clinical programs.

Key Responsibilities

1. PSDS / MAP Program Management

Create and manage new user/physician accounts in GEMS system for PSDS/MAP request submissions.
Review and evaluate PSDS/MAP requests and coordinate CMR/GMR approval processes.
Draft, coordinate, and finalize MAP/PSDS agreements and supporting documentation.
Liaise with physicians for required documentation and with Supply teams for approvals and logistics.
Generate institute codes for local supply management and maintain accurate documentation.
Train physicians and internal teams on PSDS/MAP processes and GEMS updates.
Upload and archive PSDS/MAP-related documentation within GEMS.
Collaborate with Global MAP/PSDS teams for drug forecasting and operational updates.
Participate in global and local meetings to discuss ongoing studies and MAP/PSDS activities.

2. Local Medical Affairs (MA) Studies

Manage end-to-end CTRI submissions/registrations for interventional and non-interventional studies.
Address CTRI queries and communicate with CTRI teams effectively.
Coordinate with Regulatory teams for QSRs, DCGI submissions, and local MA study documents.
Collaborate with CROs for study documentation and operational alignment.
Support self-assessment and compliance activities related to MA studies.
Prepare, review, and finalize Drug Conversion Forms (FRMs); oversee drug conversion processes.
Manage clinical drug supplies with internal and external partners.
Create and maintain repositories (Subway/NCV folders) and ensure proper document archival.
Maintain all regulatory, operational, and supply chain records in compliance with SOPs.

3. Financial and Vendor Coordination

Review and process invoices related to MA activities.
Support publication-related activities through coordination with physicians and vendors.
Facilitate vendor onboarding and qualification processes, including agreement finalization.
Collaborate cross-functionally to ensure timely project delivery and vendor compliance.

Key Skills and Competencies

Strong understanding of clinical trial operations and medical affairs processes.
Experience in regulatory document management and clinical trial systems.
Excellent cross-functional coordination and stakeholder management skills.
Expertise in documentation, archival, and compliance practices.
Proficient in Microsoft Office and clinical operations software (e.g., GEMS, eTMF).
Excellent communication, problem-solving, and organizational abilities.

Educational & Experience Requirements

Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or related field.
3–5 years of experience in clinical operations, regulatory support, or CTA functions.
Prior experience in Medical Affairs, PSDS/MAP, or Regulatory Affairs preferred.
Familiarity with Indian clinical research regulations (CTRI, DCGI) is desirable.

Summary of Impact and Contribution

Roles within Clinical Operations at the S11 level ensure the safe, compliant, and efficient conduct of clinical research.
They safeguard patient wellbeing, ensure regulatory adherence, and contribute to the success of global studies through precise documentation and operational excellence.

Core Focus Areas

Safeguarding research subject wellbeing.
Reviewing study protocols and ensuring procedural compliance.
Coordinating with clinical trial volunteers and investigators.
Following global and regional regulatory standards.
Collaborating cross-functionally to develop study materials.
Monitoring study progress and resolving operational issues.
Supporting documentation, training, and supply chain processes.

About Syneos Health (Quick Facts)

Partnered with 94% of FDA-approved novel drugs in the past 5 years.
Supported 95% of EMA-authorized products.
Delivered 200+ studies across 73,000 sites with 675,000+ participants worldwide.

Learn more: www.syneoshealth.com

Additional Information

Responsibilities listed are not exhaustive; additional duties may be assigned as needed.
The company adheres to global equal opportunity employment standards and ADA compliance.
Equivalent education and experience will be considered for qualification.
Syneos Health promotes a diverse, inclusive, and authentic workplace, encouraging all qualified candidates to apply.

Join Us

If you’re passionate about driving impactful clinical operations and contributing to global research excellence —
Apply Now or Join Our Talent Network to stay connected with future opportunities at Syneos Health.

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

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