ICON plc, a global leader in healthcare intelligence and clinical research, has announced a new hiring opportunity for the position of Study Management Associate (SMA I/II) in Bangalore, India. This is a full-time role with flexible office or home working options, ideal for experienced clinical research professionals looking to advance their careers in global clinical trial management.
As a Study Management Associate at ICON, you will play a critical role in end-to-end clinical study delivery, ensuring timelines, quality, cost control, and continuous inspection readiness through effective eTMF oversight and cross-functional coordination.
This opportunity is particularly relevant for candidates with experience in clinical operations, TMF management, ICH-GCP compliance, CRO oversight, and study coordination.
🔍 Key Responsibilities – Study Management Associate (SMA I/II)
- Partner with the Study Manager (SM) / Study Delivery Lead (SDL) on end-to-end study operations from set-up to archival
- Set up, maintain, and ensure completeness of eTMF, CTMS, study trackers, and project plans (CSAP)
- Monitor study conduct, identify risks, and escalate operational or quality issues proactively
- Review key clinical documents such as Protocols and Informed Consent Forms (ICFs)
- Lead development of study plans including:
- Monitoring Plan
- Vendor Management Plan
- Risk Management Plan
- Communication Plan
- Protocol Deviation Management Plan
- Manage CROs and third-party vendors, ensuring timely delivery and oversight of delegated activities
- Act as a primary contact for country oversight, including recruitment, regulatory approvals, deviations, and budgets
- Coordinate study meetings, communications, action logs, and stakeholder interactions
- Ensure inspection readiness through continuous eTMF completeness and quality checks
- Support budget tracking, change orders, invoice reconciliation, and financial issue escalation
- Contribute to cross-functional squads under ICON’s agile delivery model
🎓 Eligibility & Qualifications
Educational Requirements
- Bachelor’s degree in Life Sciences or a related discipline (mandatory)
Experience Requirements
- Minimum 4+ years of relevant experience in:
- Clinical research
- Pharmaceutical or biotech organizations
- CRO or scientific environments
Required Skills & Knowledge
- Strong understanding of ICH-GCP, clinical trial regulations, and drug development
- Hands-on experience with Trial Master File (TMF) systems and industry standards
- Knowledge of clinical study delivery processes and operational best practices
- Excellent project management, stakeholder management, and communication skills
- Proficiency in MS Excel, Word, PowerPoint, Outlook (advanced Excel is an advantage)
- Ability to manage multiple studies with a risk-based and quality-focused approach
💼 Salary & Benefits (India)
- Estimated Salary Range: ₹8,00,000 – ₹14,00,000 per annum (CTC), depending on experience
- Comprehensive health insurance for employee and family
- Competitive retirement and life assurance plans
- Flexible work arrangements (office or home)
- Global Employee Assistance Program (TELUS Health)
- Paid annual leave and work-life balance initiatives
- Optional benefits such as gym memberships, childcare support, and travel subsidies
📝 How to Apply
