Novartis

Global pharmaceutical company delivering science-based innovations

Monitoring Service Oversight Manager

Clinical Research OperationsConfirmed live in the last 24 hours

Full-timeMumbai, Maharashtra, IndiaNo salary listedIn-person

About the Job

Requirements

A degree in a scientific or health discipline is required.
At least 7 years of experience in clinical research, planning or executing and/or monitoring clinical trials.
Experience and evidence of team leadership capabilities.
Understanding of all aspects of clinical drug development, particularly monitoring and trial execution.
Good communication and negotiation skills, with the ability to influence others.
Stakeholder management capabilities, including demonstrated ability to solve problems 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 support and solve problems, anticipate potential risks and issues, and take appropriate actions; ability to drive the right mindset and behavior among team members.

Responsibilities

Serve as the primary point of contact for country FSP line management and other vendors providing monitoring services.
Develop the FSP resourcing strategy and align it with vendor line management for CRAs and other vendor resources.
Oversee country trial site activation, enrolment, data flow, and timeline commitments to ensure they are delivered according to established trial objectives.
Oversee monitoring quality, timely data entry, and issue resolution, including CRA oversight visit performance.
Collaborate with the CRA Manager and other internal stakeholders on the country resource strategy.
Hire, train, develop, and retain assigned internal CRAs, if any.
Oversee monitoring performance targets according to defined performance and quality indicators, including site recruitment, commitments, data health metrics, and document health metrics.
Manage resources and align with FSP line managers on CRA trial and site allocations.

Desired Qualifications

An advanced degree is preferable.
Budget Management.
Clinical Research.
Clinical Study Reports.
Clinical Trials.
Clinical Trials Monitoring.
Data Analysis.
Health Sciences.
Life Science.
People Management.
Regulatory Compliance.

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

About the Company

Novartis

Global pharmaceutical company delivering science-based innovations

Novartis is a global pharmaceutical company that uses science-based innovations to develop treatments and improve patient outcomes worldwide. Its products are medicines developed through research and development to address various diseases, aiming to reach nearly 1 billion people. The company differentiates itself by large-scale investment in R&D, a global presence with a diverse workforce, and a clear mission to Reimagine Medicine, focusing on meeting the changing needs of patients. Its goal is to improve quality of life and extend life expectancy by delivering meaningful therapies through its research and development efforts.

Company size: 10,001+
Company stage: IPO
Headquarters: Basel, Switzerland
Founded: 1970

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