Monitoring Service Oversight Manager

IN10 (FCRS = IN010) Novartis Healthcare Private Limited; Mumbai; On-site; INR 1,200,000 - 2,200,000; Full time

Job summary

Novartis Healthcare Private Limited in Mumbai seeks an experienced Clinical Research Manager to oversee monitoring services within FSP and vendor networks for Novartis-sponsored trials. You will manage country monitoring, performance indicators, data health, and trial site activation, with a focus on resource planning and team leadership.

The role requires 7+ years in clinical research, strong communication and negotiation skills, and the ability to influence stakeholders.

Qualifications

• Minimum 7 years in clinical research - planning/executing and/or monitoring clinical trials.
• Experience and evidence of team leadership capabilities.
• Understanding of all aspects of clinical drug development with particular emphasis on monitoring and trial execution.

Responsibilities

• Primary point of contact for country FSP line management and other vendors providing monitoring services.
• Develops FSP resourcing strategy and aligns it with vendor line management (for CRAs and other vendor resources).
• Oversees country trial site activation, enrolment, data flow and timeline commitments are delivered per established trial objectives.
• Oversees monitoring quality, timely data entry and issue resolution including of CRA oversight visit performance.
• Collaborates with CRA Manager and other internal stakeholders for country resource strategy.
• Hiring, training, development and retention of assigned internal CRAs if any.

Skills

Team Leadership

Communication

RBM

Stakeholder Management

Problem Solving

Education

Degree in scientific or health discipline

Advanced degree preferable

Job description

Job Description Summary

Primary contact for Functional Service Providers (FSP) and other monitoring service vendors to assure adequate quality of the services & performance in Novartis sponsored clinical trials. Oversee monitoring performance targets per defined performance and quality indicators including site recruitment, commitments, data health metrics and document health metrics. Responsible for resource management, aligns with FSP line managers for CRAs to allocation of trials, sites.

Major accountabilities

• Primary point of contact for country FSP line management and other vendors providing monitoring services
• Develops FSP resourcing strategy and aligns it with vendor line management (for CRAs and other vendor resources)
• Oversees country trial site activation, enrolment, data flow and timeline commitments are delivered per established trial objectives
• Oversees monitoring quality, timely data entry and issue resolution including of CRA oversight visit performance
• Collaborates with CRA Manager and other internal stakeholders for country resource strategy
• Hiring, training, development and retention of assigned internal CRAs if any

Essential Requirements

• Minimum 7 years’ experience in clinical research - planning/executing and/or monitoring clinical trials
• Experience and evidence of team leadership capabilities
• Understanding of all aspects of clinical drug development with particular emphasis on monitoring and trial execution
• Degree in scientific or health discipline required and advanced degree preferable
• Good communication and negotiation skills, ability to influence others
• Stakeholder management capabilities with demonstrated capability to problem solve and mediate complex issues
• Good understanding of the Risk Based Monitoring process and requirements
• Ability to anticipate potential issues and take appropriate actions
• Excellent coaching capability to best support and solve problem, anticipate potential risk, issues and take appropriate actions
• Drive right mindset and behavior to team members

Skills Desired

• Budget Management
• Clinical Research
• Clinical Study Reports
• Clinical Trials
• Clinical Trials Monitoring
• Collaboration
• Data Analysis
• Decision Making
• Health Sciences
• Life Science
• People Management
• Regulatory Compliance

Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives.

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