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Job ID

388304BR

About the role

Accountable for the oversight and coordination of program and study level (re-)feasibility assessments in the country or extended country group (OPCs & satellite countries), in collaboration with program and/or trial feasibility teams, in compliance with Novartis processes, GCP, ICH and regulatory requirements. This position is key to establish good communication and professional relationships with clinical investigators and company collaborators on country/cluster/hub/global level

Closely collaborates with Study & Site Operations and relevant medical/clinical functions to ensure successful allocation, realistic country targets, recruitment according to planned timelines, early identification of risks and opportunities as well as potential delays and mitigation plan.

Single point of contact for communication between Clinical Operations Program Managers / Clinical Operations Program Head, country/extended country group Study & Site teams and local relevant medical/clinical functions for all requests for program/study feasibility

Coordinates the feasibility activities on country/extended country group level by ensuring:

Site identification and selection, trial feasibility evaluation

Collates/validates the list of potential sites by applying internal and external data (e.g. historical data, individual knowledge within local Study & Site Team and relevant medical/clinical functions, internal and external databases)

Leads the study specific feasibility questionnaire and sends to all participating sites together with any supporting documentation, if applicable

Follows up with sites to ensure questionnaires are answered and any additional feedback is obtained

Assess the clinical feasibility of implementing a clinical trial protocol based on regional/local medical practice using physician interviews, local databases (RWE, payer data, patient association feed-back, etc.) and analysis of the driven environment

Enters feedback into global database if applicable (e.g. CLIP).

Collects, analyses, and interprets data to provide comprehensive proposals and timelines for country / extended country group allocation of clinical programs and assigned trials

Responsible for early identification for potential risks and opportunities as well as potential synergies and back-up strategies within the country/extended country group

Closely collaborates with the Study & Site team to ensure fast clinical trial start up, recruitment according to planned timelines, early identification of potential delays and robust recruitment mitigation plan. Co-own start-up phase and the recruitment plan for development clinical trials with the Study & Site Operations.

#gco

Position Title

SSO Feasibility Manager

Role Requirements

Education:

Scientific degree and advanced degree with clinical trial experience and/or project management, is preferable

Languages:

  • Fluent in both written and spoken English

Experience/Professional requirement:

  • Minimum 5 years’ experience clinical development experience in pharmaceutical industry
  • Capable of leading in a matrix environment, without direct reports and working cross-border
  • Ability to manage a study from the medical/clinical perspective, and a demonstrated capability to problem solve and mediate complex-clinical / medical / operational issues
  • Agility to move fast across different therapeutic areas and indications

Competencies:

  • Strong project management capabilities
  • Demonstrates a knowledge of how to adequately review and read a protocol to understand specifics of study design and answer questions regarding the trial
  • Applies a detailed understanding of the drug in question to provide medical context as it relates to disease processes, populations, and standards of care
  • Ability to assess the feasibility of implementing the protocol based on regional medical practice and sound understanding of the overall clinical development plan

Skills & Knowledge:

  • Demonstrated negotiation and conflict resolution skills both internal and external (site relationships)
  • Communicates effectively in a local/global matrixed environment

Job Type

Full Time

Country

Hungary

Work Location

Budapest

Functional Area

Research & Development

Division

Development

Business Unit

GCO GDD

Employment Type

Regular

Company/Legal Entity

Hungary

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Shift Work

No

Early Talent

No

Read Full Description
Confirmed 22 hours ago. Posted 30+ days ago.

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