Advertisement
Pharmabharat.com brings an excellent career opportunity for experienced pharma and clinical operations professionals. A Clinical Services Operational Specialist role is open at a leading global pharmaceutical organization in Mumbai (India). This position supports Clinical Services, Medical Affairs, and Global Program Management, with a strong focus on CTMS, eTMF, Trial Disclosure, dashboards, and training systems.
This role is ideal for candidates with 5+ years of experience in the pharmaceutical, IT software, or data analytics domain, looking to work in a fast-paced global clinical environment.
Job Overview
- Job Title: Clinical Services Operational Specialist
- Location: Mumbai, India
- Department: Medical & Clinical Affairs
- Industry: Pharmaceutical / Clinical Research / Data Analytics
- Experience Required: Minimum 5 years
- Education: Master’s degree or equivalent experience
Key Responsibilities
CTMS (Clinical Trial Management System)
- Develop and maintain CTMS training materials
- Act as CTMS Subject Matter Expert (SME) for user support
- Support system upgrades and new CTMS module releases
- Handle CTMS-related requests and user queries
- Perform data integrity and validation checks for reporting accuracy
Trial Disclosure
- Serve as Trial Disclosure SME
- Manage study disclosures across global disclosure registries
- Ensure compliance with internal and external disclosure requirements
eTMF (Electronic Trial Master File)
- Act as SME for document management systems
- Ensure eTMF compliance with SOPs
- Update TMF as per DIA eTMF reference model and release notes
Training & Systems
- Support training documentation and learning systems within the Medical Office
- Act as super user for selected systems
- Maintain CTMS training matrix
- Develop and update CTMS training courses
- Coordinate with Learning Management System (LMS) teams
SOP & Quality
- Contribute to SOP review and updates
- Support quality control and compliance activities
Dashboards & Analytics
- Support creation of dashboards using Power BI or other BI tools
- Enable data-driven insights for internal stakeholders
Stakeholder Interaction
- Internal: Medical Affairs, Clinical Development, Pharmacovigilance, QA, Regulatory Affairs, Ethics & Compliance
- External: Vendors, consultants, contractors, and business partners
Eligibility Criteria
Educational Qualification
- Master’s in Science / Computers / Advanced Data Analytics
- Equivalent industry experience will be considered
Experience & Skills
- Minimum 5 years’ experience in pharma, IT software, or data analytics
- Experience in global clinical operations environments
- Strong knowledge of CTMS, eTMF, Trial Disclosure
- Proficiency in MS Excel and MS Word
- Experience in records management, quality control, and system management preferred
- Excellent attention to detail and multitasking ability
- Fluent in English
Salary & Benefits
- Estimated Salary: ₹10,00,000 – ₹18,00,000 per annum
- Competitive compensation aligned with industry standards
- Opportunity to work in a global pharmaceutical environment
- Exposure to advanced clinical systems and analytics platforms
- Career growth in Medical and Clinical Affairs
How to Apply
Advertisement
Advertisement
