Associate Manager 1

Biopharma Careers; Bengaluru; On-site; INR 1,100,000 - 1,900,000; Full time

Job summary

Biopharma Careers is seeking a skilled L3 support specialist to deliver production support for Medidata clinical systems, including Rave EDC, Coder+, Designer, and related modules. You will collaborate with interface teams, manage incidents, and lead RCA efforts to prevent recurrence.

Ideal candidates possess 4–8 years of hands-on support experience in regulated clinical environments, with strong analytical and communication skills and familiarity with FDA/ICH/GxP standards.

Qualifications

• 4–8 years of hands-on L3 support for Medidata clinical systems in production.
• Experience with incident, problem, and change management in regulated environments.
• Strong analytical, troubleshooting, and communication skills.
• Familiarity with FDA, ICH, GCP and GxP requirements.

Responsibilities

• Provide Level 3 production support for Medidata clinical data management systems (Rave EDC, Coder+, Designer, Rave Safety Gateway, TSDV).
• Manage incidents, problems and changes within defined SLAs; perform root cause analysis (RCA).
• Coordinate with interface/integration teams for troubleshooting and impact analysis.
• Support validation activities, audits, and data integrity reviews.
• Lead audit readiness and documentation updates (qualifications, TS/TRA/FRS).
• Ensure platform deployments across DEV, TEST, PROD follow validated procedures.

Skills

L3 support

Medidata Rave EDC

Incident management

Problem management

Change management

ITIL knowledge

Analytical skills

Troubleshooting

Communication skills

Education

Bachelor's degree in Life Sciences/CS/IT

Tools

Medidata Rave EDC

Coder+

Designer

Rave Safety Gateway

TSDV

Job description

Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimageable with us.

Who you are:

• Provide Level 3 production support for Medidata clinical data management systems like Rave EDC, Coder+, Designer, Rave Safety Gateway, and TSDV, addressing complex configuration, functional, and data-related issues.
• Impact and Risk Assessment for Medidata Releases and Configuration Changes
• Carry out approved configuration tasks in accordance with defined procedures and change controls.
• Outage Management
• Support and manage planned and unplanned outages, including communication, troubleshooting, and service restoration.
• Release and Change Management
• Manage all aspects of release and change activities, including planning, documentation updates, deployment, and postimplementation review.
• L3 Incident Management and Troubleshooting
• Provide Level3 support for complex incidents, perform advanced troubleshooting, and timely resolution.
• Interface Team Coordination
• Collaborate with interface/integration teams to provide required technical details, troubleshooting assistance, and impact analysis.
• Problem Management
• Conduct problem investigations, identify root causes, recommend corrective actions, and support prevention of recurring issues.
• Audit Support
• Provide required evidence, documentation, and support during internal and external audits.
• Qualification Documentation Updates
• Update and maintain operational phase qualification documents, including TS, TRA, CS, FRS, Admin Guides, and related artifacts.
• Review of Data Integrity, Backup, and Disaster Recovery (DR)
• Perform periodic reviews of data integrity controls, backup processes, and DR readiness for compliance and operational continuity.
• Act as the final escalation point for high-impact or recurring issues from L1/L2 support teams.
• Perform deep root cause analysis (RCA) and implement permanent fixes or preventive controls.
• Support approved configuration changes and minor enhancements in line with change management processes.
• Manage and resolve incidents, problems, and change requests within defined SLAs.
• Coordinate with internal IT teams, vendors, and platform providers for issue resolution and defect remediation.
• Support production deployments across DEV, TEST, and PROD environments following validated procedures.
• Perform impact assessments for platform releases, patches, and hotfixes affecting live studies.
• Ensure all changes and configurations comply with FDA, ICH, GCP, and GxP requirements.
• Support validation activities, audit readiness, inspection support, and periodic access reviews.
• Ensure data integrity, audit trail compliance, and adherence to security and blinding controls.
• Create and maintain technical documentation, configuration notes, SOPs, work instructions, and knowledge base articles.
• Provide technical guidance and mentoring to L1/L2 support teams.
• Contribute to continuous improvement initiatives to enhance system stability and support efficiency.

• Bachelor's degree in Life Sciences, Computer Science, Information Technology, or a related field.
• 4 to 8 years of hands-on experience providing L3 support for Medidata clinical systems in production, specifically Medidata Rave EDC, Coder+, Designer, Rave Safety Gateway, and TSDV.
• Strong understanding of clinical trial data flows, regulated environments, and support models.
• Proven experience in incident, problem, and change management.
• Excellent analytical, troubleshooting, and communication skills.

Your Role :

• Experience working in AMS / Managed Services engagements for global pharmaceutical or biotech clients.
• Exposure to clinical data integrations, reporting, and reconciliation.
• Experience supporting UAT defect triage, validation, and audit inspections.
• Knowledge of ITIL-based support processes.

What we offer:

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!