Monitoring Services Oversight Manager

hace 3 semanas

Barcelona, España Novartis A tiempo completo

*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

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