CRA II / Sr CRA II – Oncology Clinical Monitoring (Mumbai Location)
Job Summary
Syneos Health is hiring a CRA II/Sr CRA II for a client-based opportunity in Mumbai, focused on on-site clinical monitoring in the oncology therapeutic area. Candidates must have minimum 4 years of on-site monitoring experience and strong knowledge of GCP and clinical trial protocols. Join a global biopharmaceutical leader supporting studies across 110 countries and advancing groundbreaking therapies.
Key Responsibilities
Perform comprehensive on-site and remote clinical trial monitoring in compliance with ICH-GCP and regulatory guidelines.
Review study protocols, informed consent forms, and case report forms for accuracy and compliance.
Develop monitoring tools such as plans, checklists, and SOPs to ensure quality oversight.
Track study progress, conduct site visits, and manage documentation including monitoring reports and follow-up letters.
Coordinate with investigators, site staff, and cross-functional teams to maintain study quality and timelines.
Resolve site-level issues and escalate risks when necessary.
Support inspection readiness and study closeout activities.
Required Skills & Qualifications
Bachelor's degree in Life Sciences, Pharmacy, or a related field.
Minimum 4 years of clinical research monitoring experience, preferably in oncology trials.
Strong command of Good Clinical Practice (GCP) and local regulatory requirements.
Excellent organizational, time management, and problem-solving skills.
Proficiency in clinical trial systems and tools (e.g., CTMS, EDC).
Preferred certification: CCRA (Certified Clinical Research Associate) or equivalent.
Strong written and verbal communication and stakeholder engagement capabilities.
Perks & Benefits
Work with a leading global biopharma company in cutting-edge clinical trials.
Technical and therapeutic area-specific training and development.
Performance-based recognition and total rewards program.
Inclusive and supportive work environment aligned with the Total Self culture.
Opportunity to work with 94% of all novel FDA-approved drugs in recent years.
Company Description
Syneos Health® is a global leader in integrated biopharmaceutical solutions. With over 29,000 professionals across 110 countries, we’ve supported 94% of FDA-approved novel drugs and bring deep clinical, commercial, and regulatory expertise to deliver meaningful outcomes across the healthcare spectrum.
Work Mode
On-site (Preferred candidates from Mumbai)
Call to Action
Ready to advance your clinical research career in a dynamic, oncology-focused role? Apply now and make a lasting impact in global drug development with Syneos Health.
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