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Apply to JobJob ID261960BRPosition TitleSenior Global Process Control Manager, Trial MonitoringJob DescriptionThe Sr. PCM is accountable for leading global quality process improvement and compliance activities and for oversight and control of quality in Trial Monitoring Operations. In this role you will work collaboratively with Clinical Quality Assurance to ensure improvement of quality and completion of risk management activities.



Your responsibilities will include:

Metrics and Quality KPI – Leads the tracking and reporting of compliance to the established clinical trial processes. Responsible to analyze, track, report and reinforce adherence to applicable performance measures. Oversees and recommends corrective actions based upon report outputs; ensures that training is developed and implemented as applicable to redirect teams to better Quality KPI scores. Tracks audit and inspection findings, report on results, track trends, generate lessons learned. Ensures effective ongoing operations of the Risk Mitigation Assessment process to improve the rate of compliance of countries to TMO quality standards.



• Process Expertise – serves as subject matter expert and input into new SOPs on behalf of TMO, ensures compliance to and adequate training opportunities for new SOPs and Business Guidance. Represents TMO at the PTGB and serves as deputy for Global Head of Monitoring Excellence. Serves as Lead SME on the monitoring processes as requested. Ensures the alignment of TMO and other monitoring groups to create the most effective and complaint process improvements. Tracks deviations from Monitoring SOPs and ensure appropriate documentation is filed and corrective actions are taken. Identifies procedural gaps and drives correction with process improvements where applicable. Conducts and supports conduct of vendor qualifications as needed; documents and files qualification evidence appropriately.



• Process Compliance – Ensures CAPA commitments are adequate, submitted and completed in a timely manner. Ensures audits and inspections are supported and tracked and outcomes requiring corrective action are managed. Reviews CAPAs and makes appropriate recommendations to keep consistent actions across TMO. Initiates and documents root cause investigations of critical issues in collaboration with Quality Assurance and Clinical Operations. Supports the generation and dissemination of Tactical Memos and Lessons Learned communication in collaboration with monitoring training. Leads the conduct of Trial Master File quality control checks. Ensures TMO compliance with required training by tracking and reporting compliance status for the Global, Regional and Country level organizations. Identifies gaps and assign action where needed to promptly gain compliance.



Minimum requirementsWhat you’ll bring to the role:

College or University degree with significant life science experience. Advanced degree in life sciences preferred.

A minimum of 8 years in a R&D regulated environment in a relevant pharmaceutical or health care company, desirable clinical operations experience

• Extensive knowledge and experience in ICH-GCP Process Control or ICH-GCP Quality Assurance systems and Health Authority regulations; Clinical Operations experience in these areas is preferred

• Demonstrated ability for leading initiatives with cross-functional teams and implementation of recommendations

• Experience working in matrix environment and in global teams

• Excellent interpersonal, problem-solving, negotiation and conflict resolution skills

• Excellent organizational skills, as well as predisposition to quality management and process improvement

• Excellent communicator and presenter



Language: Fluent in both written and spoken English. Additional language, if used for local Business purposes.



WHY CONSIDER NOVARTIS?

817 million. That’s how many lives our products touched in 2018. And while we’re proud of that, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are empowered to ask new questions, make bolder decisions and take smarter risks.

We are Novartis. Join us and help reimagine medicine.DivisionGlobal Drug DevelopmentBusiness UnitGDO GDDLocationSwitzerlandSiteBaselCompany/Legal EntityNovartis Pharma AGFunctional AreaQualityJob TypeFull TimeEmployment TypeRegular

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