Monitoring Service Oversight Manager

Novartis; Mumbai; On-site; INR 3,500,000 - 6,000,000; Full time

Job summary

Novartis AG in Mumbai seeks an experienced clinical research leader to oversee FSP vendors and CRA resources across sponsored trials. You will ensure quality and performance against indicators, and coordinate with line managers for trial allocation and site metrics.

You will lead enrollment and data flow activities, monitor risk, coach team members, and collaborate with stakeholders to deliver on trial objectives with a focus on monitoring excellence and regulatory compliance.

Qualifications

• 7+ years in clinical research, with leadership experience.
• Degree in scientific or health discipline; advanced degree preferred.
• Strong communication, negotiation and stakeholder management skills.

Responsibilities

• Serve as primary contact for country FSP line management and vendors.
• Develop FSP resourcing strategy and align with vendor line management for CRAs.
• Oversee site activation, enrolment, data flow and timeline commitments.
• Collaborate with CRA Manager on country resource strategy and staff development.

Skills

Clinical research

Leadership

Stakeholder management

Communication

Negotiation

Risk based monitoring

Education

Scientific/health degree

Advanced degree preferred

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 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