You oversee the Study Start-Up process, ensuring compliance and quality in documentation while managing resources and productivity. Collaborating with global teams is essential for meeting timelines and addressing challenges.
Anforderungen
- •University degree in scientific discipline
- •Minimum 8 years’ experience in clinical operations
- •Minimum 4 years’ experience in people management
- •Excellent understanding of clinical drug development
- •Thorough understanding of international drug development
- •Strong interpersonal and negotiation skills
- •Effective communication in matrixed environment
- •Fluent in written and spoken English
Deine Aufgaben
- •Collaborate with SSO Cluster Head and global study team.
- •Ensure SSU timelines and deliverables meet country commitments.
- •Maintain accuracy and quality of Trial Master File documents.
- •Ensure TMF inspection readiness throughout the study.
- •Adhere to financial standards and regulatory requirements.
- •Promote a compliance culture and ethical integrity.
- •Manage resource allocation and reporting for the Study Start-Up Team.
- •Oversee productivity targets and serve as an escalation point.
- •Plan and communicate future portfolio expectations with SSO Cluster Head.
- •Interface with Global SSU Teams to provide feedback and manage timelines.
Original Beschreibung
# SSO Study Start-Up - Cluster Head
**Basel (City)** | **Full time**
**Band**
Level 6
**Job Description Summary**
LOCATION: Basel City, Switzerland
ROLE TYPE: Hybrid Working, #LI-Hybrid
The Study & Site Operations (SSO) Study Start-Up (SSU) Cluster Head is accountable for the governance and oversight of the study start-up team in the cluster. They are accountable for the cluster SSU strategy and prioritization in close collaboration with SSO Cluster Head Portfolio and SSO Country Heads to deliver operational excellence of the Global Drug Development (GDD) portfolio in compliance with Novartis processes, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use )ICH) / Good Clinical Practice (GCP) and regulatory requirements. The role may support larger scope projects and governance in SSU as applicable
**Job Description**
Collaborating with the Study & Site Operations Cluster Leadership Team to identify innovative practices to optimize cluster operations and operational excellence, especially in terms of study start-up activities to increase performance, productivity, and business impact. The SSO SSU Cluster Head defines and continuously optimizes cluster SSU strategy in close collaboration with the SSO Cluster Head and SSO Cluster Head Portfolio, whilst being accountable for timely start-up activities from country allocation until Green Light (ready-to-initiate-sites). They will also ensure close collaboration with local Institutional Review Boards (IRBs) / Independent Ethics Committees (IECs) and Health Authorities (HA).
**Major accountabilities:**
* Collaborates with SSO Cluster Head Portfolio, SSO Portfolio Team Leads and global study team to ensure SSU timelines and deliverables are met according to country commitments
* Accountable for timelines, accuracy, and quality of Trial Master File (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, HA and Standard Operating Procedure (SOP) requirements
* Promotes a compliance culture advocating the adherence to highest standards and ethical integrity, ensuring human subject protection and reliability of trial results at all time
* Resource management and reporting of Study Start-Up Team
* Manages and oversees productivity targets per defined objectives, and serves as an escalation point for Study Start-Up functions
* Collaborates with SSO Cluster Head Portfolio to plan, track, and communicate future portfolio expectations.
* Direct Interface with Global SSU Teams to provide feedback on future and ongoing programs and trials, plan timelines, and proactively manage issue resolution for full portfolio within the Cluster.
**Key performance indicators:**
* Performance against study commitments at the cluster level (actual vs. planned patients), including set-up/delivery of trials per defined timelines and milestones (IRB/IEC & HA approval, Regulatory Information System (RIS), Site Initiation Visit (SIV)) and data quality requirements
* Delivery of study milestones in adherence to prevailing legislation, ICH/GCP, IRB/IEC, HA and SOP requirements
* Timely submission and delivery of high-quality clinical trial documentation/data
**Minimum Requirements:**
* A university degree in scientific or health discipline required
* Minimum 8 years’ experience in clinical operations and planning
* Minimum 4 years’ experience in people management and team leadership
* Excellent 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
* Strong interpersonal, negotiation and conflict resolution skills
* Communicates effectively in a local/global matrixed environment
* Fluent in both written and spoken English
**Skills Desired**
Clinical Research, Clinical Trials, People Management, Program Management, Regulatory Compliance, Resource Management (Organizational), Risk Management