SSO Study Start-Up Team Lead

Job Description Summary

Job Description

#LI-Hybrid

Location: Amsterdam Netherlands

Study Start-Up Strategy

Supports Study & Site Operations Country Leadership Team to identify innovative practices to optimize country operations and operational excellence especially in terms of study start-up activities to increase performance productivity and business impact

Seeks and evaluates external knowledge and best practices to enhance overall operational excellence of country trial operations

Supports country SSU strategy in close collaboration with SSU/OPC Head and Portfolio Head/Portfolio Team Lead(s)

Responsible for timely start-up activities from country allocation until site Green Light (ready-to-initiate-sites)

Ensures close collaboration with local IRBs/IECs and Health Authorities as applicable

Allocation initiation and conduct of trials

Collaborates with Head Portfolio SSO Portfolio Team Leads and global study team (Clinical Operations Program Head Trial Lead) to ensure SSU timelines and deliverables are met according to country commitments

Accountable for timelines accuracy and quality of TMF documents including study start-up and ongoing TMF maintenance to ensure TMF inspection readiness

Ensures adherence to financial standards prevailing legislation ICH/GCP IRB/IEC Health Authority and SOP requirements

Implements innovative and efficient processes which are in line with Novartis strategy

People and resource management

Hiring training development and retention of Study Start-Up associates

Resource management and reporting of Study Start-Up associates

Ensures associates have the required level of skills to successfully set-up and execute studies with high quality and according to business objectives

Manages and oversees productivity targets per defined objectives and serves as an escalation point for Study Start-Up functions

Key Performance Indicators

1. Performance against study commitments at the country level (actual vs. planned patients) including set-up/delivery of trials per defined timelines and milestones (IRB/IEC & HA approval RIS SIV) and data quality requirements

2. Delivery of study milestones in adherence to prevailing legislation ICH/GCP IRB/IEC Health Authority and SOP requirements

3. Timely submission and delivery of high-quality clinical trial documentation/data

Experience/Professional requirement:

Minimum 5 years experience in clinical operations and planning

Proven leadership capabilities and experience (with or without direct line management responsibilities).

Understanding of all aspects of clinical drug development with particular emphasis on trial set-up execution and monitoring

Thorough understanding of the international aspects of drug development process including strong knowledge of international standards (GCP/ICH) health authorities (FDA/EMA) local/national Health Authorities regulations and Novartis standards

Competencies:

Strong capability in working in a global/country matrix environment

Proven successful leadership of teams (with or without direct reports) preferably with experience in working with international teams

Skills & Knowledge:

Strong interpersonal negotiation and conflict resolution skills

Communicates effectively in a local/global matrix environment

Commitment To Diversity And Inclusion

Novartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve.

Skills Desired