Monitoring Service Oversight Manager

Novartis; Mumbai City; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

Novartis AG in Mumbai seeks an experienced clinical monitoring leader to partner with FSPs and vendors, ensuring quality and performance in Novartis sponsored trials.

You will oversee country trial site activation, data flow, and timelines, while aligning CRA resources and monitoring targets with program objectives.

The role emphasizes leadership, stakeholder management, and risk-based monitoring to anticipate issues and drive study success.

Qualifications

• Experience in planning/executing and/or monitoring clinical trials.
• Proven leadership capabilities in a team environment.
• Understanding of clinical drug development with emphasis on monitoring and trial execution.
• Strong communication and negotiation skills.

Responsibilities

• Primary contact for country FSP line management and vendors.
• Develops FSP resourcing strategy and aligns with vendor line management for CRAs.
• Oversees country trial site activation, enrolment, data flow and timeline commitments.
• Oversees monitoring quality, timely data entry and issue resolution for CRA oversight visits.
• Collaborates with CRA Manager for country resource strategy and staff development.

Skills

Clinical Research

Clinical Trials Monitoring

Budget Management

Data Analysis

Decision Making

Health Sciences

Life Science

People Management

Regulatory Compliance

Collaboration

Education

Degree in scientific or health discipline

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.

Job Description

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 requirementsAbility 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