Sr. Clinical Operation Specialist (CTA, Client-Based – Mumbai Location)
Company: Syneos Health®
Location: IND – Client (Mumbai)
Job ID: 25102667
Updated: October 24, 2025
About Syneos Health
Syneos Health® is a fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We merge clinical development, medical affairs, and commercial expertise to deliver results that address real-world healthcare challenges.
With 29,000 employees across 110 countries, Syneos Health is continuously simplifying processes to make collaboration easier and accelerate the delivery of life-changing therapies.
Our Impact:
Partnered in 94% of all novel FDA-approved drugs in the past 5 years
Supported 95% of EMA-authorized products
Conducted 200+ studies across 73,000 sites involving over 675,000 patients
Our Culture:
Built on the “Total Self” philosophy — fostering authenticity, inclusivity, and well-being
Emphasis on career development, therapeutic training, peer recognition, and total rewards
Driven by teamwork, agility, and diversity of thought
Role Overview
The Senior Clinical Operation Specialist (CTA) is a key member of the Clinical Operations team responsible for end-to-end management of PSDS/MAP programs, regulatory submissions for medical affairs (MA) studies, drug supply coordination, and vendor management.
This role involves cross-functional collaboration with internal stakeholders (Medical Affairs, Regulatory, Patient Safety) and external partners (CROs, vendors, and investigators) to ensure compliance, accuracy, and operational efficiency.
Key Responsibilities
1. PSDS / MAP Program Management
Support creation and onboarding of new physician/user accounts in the GEMS system for PSDS/MAP request submissions.
Review and assess incoming PSDS/MAP requests, coordinating approvals with CMR/GMR teams.
Draft, finalize, and distribute MAP/PSDS agreements and associated documentation.
Coordinate with physicians and supply teams to ensure smooth drug supply approvals and logistics.
Generate institute codes for local supply chain activities.
Maintain document updates and archival in GEMS.
Collaborate with the Global MAP/PSDS team for drug forecasting and related processes.
Provide training and support on MAP/PSDS processes to internal teams and external physicians.
Participate in global and local meetings to review MAP/PSDS and study progress.
2. Local Medical Affairs (MA) Studies
(Interventional / Non-Interventional / Research Collaborations)
Manage end-to-end CTRI submissions/registrations for MA studies, including query resolution and communication with CTRI.
Coordinate with the Regulatory team for submission of QSR and DCGI dossiers.
Liaise with CROs for documentation, study start-up, and activity tracking.
Support self-assessment and internal audit readiness for MA operations.
Handle drug conversion requests and manage Drug Conversion Forms (FRMs).
Coordinate drug supply logistics with clinical sites and supply chain teams.
Ensure document repository maintenance (Subway/NCV folders) and proper archival in the electronic repository.
Maintain updated regulatory and operational documentation per compliance standards.
3. Financial & Vendor Coordination
Review and process invoices related to MA activities.
Support publication coordination with physicians and external vendors.
Assist in vendor onboarding, qualification, and agreement finalization.
Track and manage contract execution and sign-off processes for operational vendors.
Key Skills & Competencies
Strong understanding of clinical trial operations and medical affairs processes
Experience in regulatory submissions and document management systems
Skilled in clinical systems (e.g., GEMS, eTMF, regulatory portals)
Proficient in cross-functional collaboration with internal/external teams
Excellent communication, coordination, and organizational skills
Detail-oriented with strong documentation and compliance mindset
Qualifications
Education:
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or a related field
Experience:
Proven experience in clinical trial administration, medical operations, or clinical regulatory coordination
Prior exposure to MAP/PSDS program management preferred
Experience working with global cross-functional teams and CROs/vendors is an advantage
Functional Level: S11 – Clinical Operations
Core Focus Areas:
Safeguard subject well-being and ensure compliance with global regulatory standards
Support operational execution of clinical and medical affairs studies
Review study protocols, manage documentation, and monitor progress
Coordinate volunteer/patient communication and regulatory submissions
Collaborate with cross-functional stakeholders to ensure quality and adherence to SOPs
Provide organizational and administrative support to ensure operational excellence
Work Environment
Client-based role (Mumbai location)
Full-time position within the Clinical Operations division
Collaboration with global and local teams under hybrid or on-site setup
Equal Opportunity Statement
Syneos Health is an equal opportunity employer committed to diversity, inclusion, and fairness. We provide reasonable accommodations in accordance with the Americans with Disabilities Act (ADA) and applicable laws globally.
Learn more: www.syneoshealth.com
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