Sso Country Head Portfolio - Milano, Italia - Novartis

Novartis

Azienda verificata

Milano, Italia

2 settimane fa

Inviato da:

Piero Bianchi

Reclutatore di talenti per beBee

Descrizione

100,000+ That's how many patients participate in our clinical trials at any given time.

GCO is Novartis' powerhouse of Global Clinical Operations, redesigned to enable faster trial recruitment and enhanced trial delivery resulting in more timely access for patients to potential novel treatments.

Every day, we are the link between science and medicine - imagine the impact you could have as Country Head Portfolio #GCO

The Country Head Portfolio will be Accountable for the oversight and project management of the clinical trials execution in direct countries or cluster of the entire GDD portfolio in compliance with Novartis processes, GCP/ICH and regulatory requirements. Provides operational management to the Portfolio Team Leads and Site Partnership Managers (in direct countries).
You will be responsible for development of portfolio execution strategy in collaboration with SSO Hub Head Portfolio, SSO Country Head/SSO Cluster Head, Country CSO, Medical Director and Global Clinical teams, to assure effective trial execution with high quality
Your responsibilities include, but are not limited to:
Study & Site Operations strategy
In alignment with the SSO Hub Head Portfolio, responsible for the successful planning and execution of the portfolio delivery at country/cluster level
Oversight on study activation, enrolment, data flow and project milestones of country/cluster portfolio in alignment with relevant medical/clinical functions
Supports Hub Portfolio Head in implementation of the global strategy within the country (incl. escalation & risk mitigation) and brings county inputs into the hub disease area strategies
Collaborate with the key stakeholders (SS) Hub Head Portfolio, SSO Portfolio Team Leads, relevant medical/clinical functions) to ensure execution of portfolio objectives for the country, prioritization, and tracking, including identification of key country portfolio issues.
In collaboration with SSO Portfolio Team Leads drives proactive risk management and contingency planning within the country/cluster and communicates program status with the respective stakeholders in a transparent and timely manner.
Supports the optimal utilization of country/cluster opportunities to build competitive advantages for global development trials, considering medical standard of care and competitive environment

Allocation, initiation and conduct of trials- In collaboration with the SSO Feasibility Managers builds the country/cluster feasibility strategy to ensure strategic allocation and execution of global development trials within the country/cluster (Innovative Medicines Phase I-IV clinical trials)

Accountable for coordination and ongoing oversight of allocation targets and ensures delivery of country/cluster allocation targets. Facilitates discussion on reallocation of study commitments for the country/cluster as needed
Partners with relevant country medical/clinical functions and SSO Site Partnership Managers to create competitive advantages allowing for an optimal footprint of trials and patients
Together with the SSO Hub Head Portfolio and CRMAs coordinates and prepares the country/cluster for upcoming programs and indications based on the agreed plan with respective Development Unit Heads (including early identification of sites in new indications, trainings of internal and external stakeholders, etc)

Delivery of quality data and compliance to quality standards- Ensures adherence to clinical data standards, prevailing legislation, GCP, Ethical Committee and SOP requirements by guiding the SSO Portfolio Team Leads

When required support issue escalation and resolution aligned with the SSO Clinical Project Manager and by partnering with relevant medical/clinical functions, GLF's and Development/Country QA, as applicable
Ensures adherence/compliance to SOPs and required training curricula per GDD and country/cluster level targets
Contributes to continuous improvement in country/cluster portfolio execution and fosters best practice sharing
Ensure timely data flow and millstones delivery

Management of people and resources management- Responsible for hiring, development and talent retention of SSO Portfolio Team Leads and SSO Site Partnership Managers (in direct countries)

Communicates specific training needs to the appropriate Training and Monitoring Excellence responsible
Tracks key performance indicators to assure end to end delivery of key milestones for the country/cluster portfolio. Assures corrective actions when needed, aligned with all relevant stakeholders

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

What you'll bring to the role:
At least 8 years' experience in clinical research, in planning/executing and/or monitoring clinical trials
People Management experience (midsize to