Monitoring Services Oversight Manager
hace 3 semanas
*Role can be based in Madrid or Barcelona*
Primary contact for FSP and other monitoring services (vendors) to assure adequate quality of the services & performance in Novartis sponsored clinical trials. Oversees vendor monitoring performance targets per defined quality performance indicators, including site recruitment commitments, timely data entry and issue resolution KPIs. Aligns with FSP and other vendor’s managers on CRA and other vendor resource related allocation to trials and studies. Requires strong communication skills and ability to influence internal and external stakeholders in order to maximize quality and efficiency of external service providers.
- Ensures timely communication with vendors’ line managers to ensure sponsor requirements are up to date - sets up governance model
- Develop resource needs/expectations strategy and align with vendor line management (CRAs and other vendor resources)
- Collaborates with Clinical Research Associate (CRA) Manager and other internal stakeholders for country resource strategy to be best single point of contact/ primary interface FSP/other vendors
- Escalates non-compliance, performance issues, competency gaps and/or needs to vendors
- 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 oversight of CRA oversight visit performance
- Oversee execution of annual CRA oversight visit plan to assess vendor issue management and oversight in close collaboration with FSP line management
- Pro
- active quality performance issue management and conduct quality oversight visits for cause as needed
- Supports Clinical Development Audit and FSP vendors for site audits and inspection
- Oversight on vendor CRAs adherence to Novartis process changes, implementation of systems and tools
- In collaboration with SSO Clinical Project Manager (CPM), supports recruitment strategies and site performance by ensuring high quality and compliance of monitoring activities
- Collaborates with SSO CPM for monitoring trends that require targeted training and/or development of CRAs to deliver to trial and quality KPIs
- Ensure country FSP strategy is aligned with global and hub plans
- Close collaboration and alignment with global/hub S&O and Vendor partnership and governance functions
- Establishes a process for managing performance (recognition/corrective action) to ensure delivery to the established Key Performance Indicators (KPI)/ Key Quality Indicators (KQI)
- Ensures that the studies under responsibility are conducted as per current legislations, ICH/GCP and Novartis standards
- Pro
- active manage FSP and other vendor related collaborations to meet all required expectations
Key Performance Indicators:
1. FSP performance against trial commitments at the country level, including delivery of trials per defined timelines, number of patients and quality
2. Delivery of high-quality clinical data ensuring adherence to prevailing legislation, GCP, Ethical Committee and SOP requirements
**Commitment to Diversity & Inclusion**:
- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
**Minimum requirements**
**Education**:
- A degree in scientific or health discipline required and advanced degree preferable (or, for United States: 4-year degree plus relevant, related healthcare experience)
Languages:
- Fluent in both written and spoken English
Experience/Professional requirement:
- 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
Competencies
- Decision making capability
- Excellent management capabilities with demonstrated capability to problem solve and mediate complex compliance issues.
- Thorough understanding of the international aspects of drug development process, including expert knowledge of international standards (GCP/ICH), health authorities (FDA/EMEA), local/National Health Authorities regulations and Novartis standards
Skills & Knowledge:
- Demonstrated negotiation and conflict resolution skills
- Fast change adaptability to best partner & influencing with FSP vendor on fast changing landscape
- Trust and rapport building is a very important skill needed
- Good communication skills, ability to influence others & Relationship management
- Excellent communicator and presenter (oral and written)
- Good analytical thinking
- Ability to anticipate potential issues and take appropriate actions with or without supervision
- Digital & tech capabilities
**Division**
Global Drug Development
**Business Unit**
GCO GDD
**Country**
Spain
**Work Location**
Barcelona Gran Vía
**Com
-
Senior Clinical Project Manager
hace 7 días
Barcelona, Barcelona, España Syneos Health, Inc. A tiempo completoDelivering High-Quality Clinical TrialsWe are seeking a highly skilled Clinical Trial Manager II to join our team. As a member of our global development team, you will be responsible for the successful delivery of clinical trials from start to finish. This includes site management oversight, clinical monitoring and central monitoring deliverables with a...
-
Solar PV Project Oversight Specialist
hace 5 días
Barcelona, Barcelona, España Green Recruitment Company A tiempo completoJob Overview:Green Recruitment Company is partnering with a leading advisory firm to recruit an experienced Senior Project Manager for their renewable energy project management team. The ideal candidate will have a strong background in solar PV project oversight, independent engineering, and technical advisory services. This is a unique opportunity to join a...
-
Central Monitoring Manager
hace 2 semanas
Barcelona, España Psi Cro Ag A tiempo completoCompany Description PSI is a leading Contract Research Organization with almost 30 years on the market, offering a perfect balance between stability and innovation to both clients and employees.We focus on delivering quality and on-time services across a variety of therapeutic indications.Job Description With the industry moving forward, the central...
-
Central Monitoring Manager
hace 4 días
Barcelona, España PSI CRO A tiempo completoCompany DescriptionPSI is a leading Contract Research Organization with almost 30 years on the market, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.Job Description With the industry moving forward, the central...
-
Central Monitoring Manager
hace 3 semanas
Barcelona, España Psi Cro A tiempo completoJob Description With the industry moving forward, the central monitoring function has become a top priority at PSI.We are looking for a person, who would lead the risk-based monitoring approach implementation on the clinical study and program level to ensure patient safety and data integrity.You will: Lead and facilitate initial and ongoing study Risk...
-
Central Monitoring Manager
hace 4 días
barcelona, España PSI CRO A tiempo completoCompany Description PSI is a leading Contract Research Organization with almost 30 years on the market, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. Job Description With the industry moving forward, the central...
-
Central Monitoring Manager
hace 5 días
Barcelona, España PSI CRO AG A tiempo completoCompany Description PSI is a leading Contract Research Organization with almost 30 years on the market, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. Job Description With the industry moving forward, the central...
-
Central Monitoring Manager
hace 3 semanas
Barcelona, España Psi Cro A tiempo completoPSI is a leading Contract Research Organization with almost 30 years on the market, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.Job DescriptionWith the industry moving forward, the central monitoring function has...
-
Central Monitoring Manager
hace 3 semanas
Barcelona, España Psi Cro Ag A tiempo completoCompany DescriptionPSI is a leading Contract Research Organization with almost 30 years on the market, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.Job DescriptionWith the industry moving forward, the central...
-
Central Monitoring Manager
hace 1 semana
Barcelona, España Psi Cro Ag A tiempo completoCompany DescriptionPSI is a leading Contract Research Organization with almost 30 years on the market, offering a perfect balance between stability and innovation to both clients and employees.We focus on delivering quality and on-time services across a variety of therapeutic indications.Job DescriptionWith the industry moving forward, the central monitoring...
-
Central Monitoring Manager
hace 2 semanas
Barcelona, España Psi Cro Ag A tiempo completoCompany DescriptionPSI is a leading Contract Research Organization with almost 30 years on the market, offering a perfect balance between stability and innovation to both clients and employees.We focus on delivering quality and on-time services across a variety of therapeutic indications.Job DescriptionWith the industry moving forward, the central monitoring...
-
Central Monitoring Manager
hace 5 días
Barcelona, España Psi Cro A tiempo completoCompany DescriptionPSI is a leading Contract Research Organization with almost 30 years on the market, offering a perfect balance between stability and innovation to both clients and employees.We focus on delivering quality and on-time services across a variety of therapeutic indications.Job DescriptionWith the industry moving forward, the central monitoring...
-
Senior Project Manager
hace 5 días
Barcelona, España Allianz Technology Se Spain Branch A tiempo completoSenior Project Manager (Monitoring) About the Job At Allianz Services, we deliver high-quality professional services to the Allianz Group, fostering innovation, efficiency, and operational excellence.Allianz Services Spain is dedicated to providing tailored solutions across various domains, contributing to the global success of Allianz.We are committed to...
-
Senior Project Manager
hace 1 día
Barcelona, España Allianz Popular Sl. A tiempo completoAt Allianz Services, we deliver high-quality professional services to the Allianz Group, fostering innovation, efficiency, and operational excellence.Allianz Services Spain is dedicated to providing tailored solutions across various domains, contributing to the global success of Allianz.We are committed to creating an inclusive, collaborative environment...
-
Senior Project Manager
hace 2 días
Barcelona, España Allianz Popular SL. A tiempo completoAt Allianz Services, we deliver high-quality professional services to the Allianz Group, fostering innovation, efficiency, and operational excellence. Allianz Services Spain is dedicated to providing tailored solutions across various domains, contributing to the global success of Allianz. We are committed to creating an inclusive, collaborative environment...
-
Senior Project Manager
hace 1 día
Barcelona, España Allianz Popular Sl. A tiempo completoAt Allianz Services, we deliver high-quality professional services to the Allianz Group, fostering innovation, efficiency, and operational excellence.Allianz Services Spain is dedicated to providing tailored solutions across various domains, contributing to the global success of Allianz.We are committed to creating an inclusive, collaborative environment...
-
Senior Project Manager
hace 2 días
barcelona, España Allianz Popular SL. A tiempo completoAt Allianz Services, we deliver high-quality professional services to the Allianz Group, fostering innovation, efficiency, and operational excellence. Allianz Services Spain is dedicated to providing tailored solutions across various domains, contributing to the global success of Allianz. We are committed to creating an inclusive, collaborative environment...
-
Monitoring Capability Enablement Manager | Tvi-436
hace 3 semanas
Barcelona, España Ares Consultores A tiempo completo.With the creation of the Workforce Solutions Business Unit, HP is accelerating the pace to become a true Managed Services player, creating outcome-based solutions for all our customer categories.Our organization designs and orchestrates the delivery of these services.Our team (Managed Services Delivery Capability Enablement) plays a key role in the design...
-
Monitoring Capability Enablement Manager |
hace 3 semanas
Barcelona, España Ares Consultores A tiempo completoWith the creation of the Workforce Solutions Business Unit, HP is accelerating the pace to become a true Managed Services player, creating outcome-based solutions for all our customer categories.Our organization designs and orchestrates the delivery of these services.Our team (Managed Services Delivery Capability Enablement) plays a key role in the design of...
-
Monitoring Capability Enablement Manager |
hace 3 semanas
Barcelona, España Ares Consultores A tiempo completoWith the creation of the Workforce Solutions Business Unit, HP is accelerating the pace to become a true Managed Services player, creating outcome-based solutions for all our customer categories.Our organization designs and orchestrates the delivery of these services.Our team (Managed Services Delivery Capability Enablement) plays a key role in the design of...