Klinera is inviting applications for the position of Clinical Data Associate at its Mumbai (Vidyavihar) office. This is an excellent opportunity for experienced Clinical Data Management (CDM) professionals with 3 to 6 years of experience who are looking to advance their careers in clinical research.

The selected candidate will work closely with clinical operations, study teams, and database programmers to ensure high-quality clinical trial data management while maintaining compliance with ICH-GCP, FDA, and EMA guidelines.

If you have experience in Clinical Data Management, EDC systems, CRF review, data cleaning, query management, Medidata Rave, Oracle Clinical, and regulatory compliance, this opportunity is worth exploring.

Job Overview

Clinical Data Associate Responsibilities

The selected candidate will be responsible for:

• Collaborating with Clinical Operations teams to manage clinical trial data.
• Supporting clinical sites in accurate completion of Case Report Forms (CRFs).
• Acting as the primary contact for clinical data queries.
• Monitoring clinical data collection activities across study sites.
• Resolving data discrepancies and missing information.
• Training site personnel on Electronic Data Capture (EDC) systems.
• Performing data quality reviews to ensure accuracy and completeness.
• Conducting data validation and maintaining audit-ready documentation.
• Supporting database setup, testing, and maintenance.
• Working with Medidata Rave, Oracle Clinical, or similar EDC platforms.
• Assisting with protocol amendment updates in clinical databases.
• Contributing to Data Management Plans (DMPs).
• Supporting study startup, monitoring, and database lock activities.
• Preparing reports for interim analysis and regulatory submissions.
• Ensuring compliance with ICH-GCP, FDA, and EMA regulations.

Required Qualifications

Candidates should possess:

• Bachelor’s or Master’s degree in:
  • B.Pharm
  • M.Pharm
  • Pharm.D
  • B.Sc Life Sciences
  • M.Sc Life Sciences
  • Biotechnology
  • Clinical Research
  • Nursing
  • Allied Health Sciences
  • Or another relevant Life Sciences discipline
• 3 to 6 years of Clinical Data Management experience.
• Strong understanding of:
  • Clinical Data Management
  • Clinical Trials
  • CRFs
  • Query Management
  • Data Validation
  • Data Cleaning
  • EDC Systems
  • Medidata Rave
  • Oracle Clinical
  • ICH-GCP Guidelines
  • FDA & EMA regulations

Preferred Skills

• Excellent analytical skills
• Strong communication abilities
• Attention to detail
• Problem-solving mindset
• Team collaboration
• Database management knowledge
• Audit readiness experience
• Documentation management

Why Join Klinera?

Working with Klinera offers professionals the opportunity to:

• Work on global clinical research projects.
• Gain exposure to international regulatory standards.
• Develop expertise in advanced Clinical Data Management systems.
• Collaborate with experienced Clinical Operations teams.
• Enhance career growth within Clinical Research.

Work Location

Vidyavihar, Mumbai

Work Schedule: 5 Days Work From Office

How to Apply

Interested candidates should email their updated resume to:

Email: prachi.sonawane@klinera.com

Include the following details:

• Current CTC
• Expected CTC
• Notice Period
• Total Years of Clinical Data Management Experience
• Willingness to work 5 days from Vidyavihar, Mumbai (Yes/No)