Sso Portfolio Team Lead - Barcelona, España - Novartis

Novartis

Empresa verificada

Barcelona, España

hace 3 semanas

Publicado por:

Isabel García

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Descripción

*Role can be based in Madrid or Barcelona*The SSO Portfolio Team Lead is responsible for the Clinical Project Managers (CPMs), SSO Feasibility Managers and SSO Site Partnership Managers and their study specific activities, including the hiring, training, development, and assignment to ensure adequate and timely portfolio execution. The SSO Portfolio Team Lead assures that CPMs coordinate their activities across all CRAs working on the same trials/projects in collaboration with the CRA Managers/FSP line managers.

The SSO Portfolio Team Lead is responsible for CPMs, SSO Feasibility Managers and SSO Site Partnership Managers compliance of study management activities and for the delivery of study milestones, in close collaboration with the CRA Mangers/ FSP line managers and aligned with Global and local medical strategy, in the country/OPC country structure.

The Portfolio Team Lead is responsible for overall portfolio execution related performance (KPIs), ensuring the study milestone deliverables, in accordance with GCP, ICH, SOP's, and local regulations.

Portfolio Execution strategy

Collaborates with Country Head, Country/Cluster Portfolio Head and CRA Managers/FSP line managers to implement country innovative practices and patient engagement tactics (as appropriate) to advance clinical trial planning, execution and quality in line with Portfolio Execution country/OPC country leadership
Identifies and leads innovative solutions to further advance the Project Management in GDD portfolio, in collaboration with Study & Site Operations country/OPC country leadership
Supports the Country/Cluster Portfolio Head in implementation of the global strategy within the country/OPC country structure (incl. escalation & risk mitigation, as well as study allocation to CPMs)
Supports the SSO Site Partnership Managers in the preparation and implementation of Key Account specific partnership strategy to ensure early engagement and timely delivery on the Novartis portfolio

Allocation, initiation and conduct of trials

Develops opportunities in collaboration with SSO Feasibility Manager, SSO Site Partnership Manager, Country/Cluster Portfolio Head and relevant medical/clinical functions to build a competitive advantage for GDD trials within the country/OPC country, ensuring alignment with the local medical standard of care, local business drivers and site relationship management
Ensures that SSO Feasibility Managers provide comprehensive proposals and timelines for country allocation, including early identification of risk and opportunities for the clinical program/trial
Operationally supports allocation of new trials in collaboration with Study & Site Operations Country/OPC country leadership, during trial feasibility/allocation
Ensures Country study site selection, activation, enrolment, data flow and timeline commitments are delivered and reported per established study milestones and Country commitments
Collaborates with the SSO Site Partnership Manager and relevant medical/clinical functions to enhance Novartis relationship with clinical sites, to ensure optimal site relationship management and delivery on study commitments

Delivery of quality data and compliance to quality standards

Collaborates with Clinical Research Associate (CRA) Manager to ensure that monitoring trends that require targeted training and/or development are escalated.
Coordinates between the Clinical Research Associate (CRA) Manager, CPM and SSO Site Partnership Manager to ensure that site issues, data flow and commitment deviations are addressed and escalated.
Ensures adherence to clinical data standards, prevailing legislation, GCP, Ethical Committee and SOP requirements
Manages CPM, SSO Feasibility Manager and SSO Site Partnership Manager adherence/compliance to SOPs and required training curricula
Ensures any competency gaps are identified and resolved through targeted training curricula in collaboration with the training and Portfolio Execution Excellence group
Supports CPO/site audits and inspections (as appropriate) related to CAPA followup and implementation of study level identified issues

Management of people and resources management

Is responsible for the hiring, training, development, and retention of a team of Clinical Project Managers (CPMs), SSO Feasibility Managers and SSO Site Partnership Managers to ensure study milestones are delivered for the Innovative Medicines Phase I-IV Global Drug Development (GDD) trials
Together with the country/cluster Portfolio Head performs ongoing assessment and allocation of CPMs, SSO Feasibility Manager and SSO Site Partnership Manager resources within Country/OPC Country/Hub to ensure balanced workload
Ensures CPMs and SSO Feasibility Managers have the required level of project management and therapeutic area knowledge and skills to successfully deliver study and protocol requirements
Is responsible for managing and addressing CPM performance targets per defined