💼 Shilpa Medicare Limited is Hiring – Clinical Affairs 💼
Clinical Trials | Asst Manager / Deputy Manager | Nacharam, Hyderabad
Shilpa Medicare Limited is hiring experienced professionals for Clinical Affairs (Clinical Trials) department at Nacharam, Hyderabad. Excellent opportunity for candidates with strong clinical operations and regulatory expertise.
📌 Position Details
- 🎓 Designation: Asst Manager / Deputy Manager
- 💉 Department: Clinical Affairs (Clinical Trials)
- ⏰ Experience: 8 – 12 Years
- 📍 Location: Nacharam, Hyderabad
- 📧 Mail ID: karthik.kumar@vbshilpa.com
- ✉️ Subject: Clinical Affairs – Clinical Trials
📝 Job Responsibilities:
- ✅ Develop and execute study-level operational strategy for clinical study delivery
- ✅ Plan, manage, and close clinical trials as per study plans and timelines
- ✅ Participate in clinical vendor/CRO selection and oversee performance
- ✅ Ensure CRO/vendor oversight for quality, timeline, and budget compliance
- ✅ Accountable for protocol execution and operational planning
- ✅ Maintain document standardization using templates, model documents & peer review
- ✅ Ensure compliance and maintenance of Trial Master File (TMF) as per GCP and SOPs
- ✅ Ensure regulatory and operational compliance and support inspections
- ✅ Train internal teams on study conduct and business processes
- ✅ Provide inputs for SOP development and harmonization as per ICH-GCP
- ✅ Review protocols and manage query resolution for clinical trials
- ✅ Review and finalize Clinical Study Reports (CSRs) for regulatory submissions
- ✅ Support facility and site audits for clinical trial execution
- ✅ Prepare study schedules, master lists, monthly updates & product availability plans
- ✅ Manage archival of Clinical Affairs documents
- ✅ Lead recruitment, training, and management of Clinical Affairs team
🌟 Key Requirements
- 🎯 Experience: 8-12 Years in Clinical Affairs/Clinical Trials/Clinical Operations
- 📚 Knowledge: ICH-GCP, TMF, CSRs, Protocol Development, CRO Management
- 📋 Skills: Regulatory compliance, SOPs, Audits, Team Management
- 🏢 Domain: Pharma/CRO/Clinical Research
📧 How to Apply
📩 Interested candidates may share their CV to: karthik.kumar@vbshilpa.com
Subject Line: Clinical Affairs – Clinical Trials
🤝 Kindly share this opportunity within your network.
❓ FAQs
1. What is the experience required for Clinical Affairs role?
A: 8 to 12 Years in Clinical Trials/Clinical Affairs.
2. What is the job location for Shilpa Medicare Clinical Affairs?
A: Nacharam, Hyderabad.
3. What is the designation offered?
A: Asst Manager / Deputy Manager – Clinical Affairs.
4. How to apply for Shilpa Medicare Clinical Affairs job?
A: Email your CV to karthik.kumar@vbshilpa.com with subject Clinical Affairs – Clinical Trials.
5. Is CRO and TMF experience mandatory?
A: Yes, experience in CRO oversight, TMF management, and ICH-GCP compliance is essential.
Clinical Trial professionals with 8-12 years experience – Apply now at Shilpa Medicare!
Tags: Shilpa Medicare Jobs 2026, Clinical Affairs Jobs, Clinical Trials Jobs Hyderabad, Asst Manager Jobs, Deputy Manager Jobs, CRO Jobs, TMF Jobs, ICH-GCP Jobs, Pharma Jobs Hyderabad, 8-12 Years Jobs, 2026
