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Cra Ii/Sr Cra Ii

2-4 years
Not Disclosed
10 July 3, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

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.

Apply Now at Syneos Health