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Opening for Clinical Supply Trial Manager in Novartis Healthcare
A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post: Clinical Supply Trial Manager
Job Purpose (State briefly the overall objective of the job)
Has operational end to end responsibility for assigned supply acitivity. Leads and manages all project and local network activities and participates in cross-functional teams.
Basic Major Activities (Describe main activities)
Coordinates internal and external stakeholders, customers and/or vendors
Contribute as unit representative on project teams. Ensure that own deliverables are met.
Act as unit representative on development teams and/or other cross functional teams
Communicates issues to involved stakeholders and propose corrective actions
Ensures lessons learned sessions are in place for own tasks
Coaching and technical training as recognized technical expert or leader. Act as mentor for junior and senior associates (including academics).
Understand resource contraints and identify and lead cost saving opportunities
Ensure compliance to Novartis and other relevant regulations. Writing and reviewing of SOPs.
Interpret results, evaluate data, draw conclusions and report back to team and management
Support cultural evolution within own function by showing positive work ethics and influencing others.
As process owner being accountable for process improvement. Drive
implementation and sustain phase within area of expertise
Key Performance Indicators (Indicate how performance for this job is measured)
Quality (GMP), quantity, and timelines for all assigned tasks/projects
Compliance with Novartis standards, in particular, ethics, health, safety, and environment (HSE), and information security (ISEC) standards.
Unit KPIs (e.g. FPFV (first patient first visit), LTA (lost time accident), FTR (first time right), Rework Rates, Recalls)
Cross-functional KPIs (if applicable)
1. Being DSM representative at Clinical Trial Team meetings proactively negotiates and communicates clinical supply plan/timeline to internal and external customers and partners.
2. Reviews clinical trial protocol and provides input to drug sections. Develops packaging design matching the study design, which ensures optimized supply plan in terms of cost, feasibility and overage.
3. Applies simulation tools to drive optimal clinical supply plan, adequately supports IRT studies.
4. Creates reviews and updates the demand plans based on strategic elements/study forecasts.
5. Triggers booklet/label design process, leads packaging design and optimization, coordinates the randomization and distribution of clinical supplies according to study design.
6. Plans budget for associated external costs for booklet lables, IRT & medication management and distribution; issues grants and purchase orders
7. Accountable for creating eCPRs with good quality (FTR), ensures that key study mi-lestones are met.
8. Performs medication management for studies using IRT
9. Timely communicates and updates clinical supply plan on study level to SCMs, ensure seemless coordination on demand/supply plan between CTTs and TRD subteams.
10. Supports internal/external inspections and audits.
11. Actively contribute to SOP creation, revision and update.
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