Clinical Trial Supply (CTS) Study Manager

CSL; Glattbrugg; Vor Ort; CHF 110.000 - 160.000; Vollzeit

Zusammenfassung

CSL in Switzerland offers a hybrid role based onsite in Zürich with a minimum of three days onsite weekly, focused on efficient clinical trial supply planning for low to medium complexity studies.

You will forecast drug volumes, manage sample storage/transport, and collaborate with external providers under outsourcing strategies to ensure cost efficiency, quality and regulatory compliance.

Qualifikationen

• Bachelor's degree in Life Sciences, Engineering, Logistics or equivalent.
• 5+ years of experience in clinical supply management in pharma.
• Knowledge of ICH-GCP regulations and conduct of clinical studies.
• Knowledge of cGMP and cGDP regulations.
• Strong interpersonal and communication skills.

Aufgaben

• Plan and manage clinical trial supply for low to medium complexity studies.
• Forecast drug volume requirements.
• Oversee sample collection, storage, transport and archiving.
• Coordinate with external providers per outsourcing strategy.
• Use IRT systems to support supply management.
• Prepare critical study documents (protocols, dossiers, handling instructions, reports).
• Lead or participate in global trial supply meetings.
• Collaborate with R&D and other functions to optimize systems.
• Drive continuous improvements and update SOPs for compliance.

Kenntnisse

Clinical supply management

Team collaboration & communication

Ausbildung

Bachelor's degree in Life Sciences / Engineering / Logistics

Jobbeschreibung

Work Environment

• This is a hybrid position based onsite at any of the posted locations with a minimum of 3 days onsite weekly. Relocation and mobility assistance are not provided.

Main Responsibilities

• Ensure efficient, cost-effective clinical trial supply planning and management for low to medium complexity studies
• Performs planning and forecasting of drug volume requirements
• Sample collection and analysis
• Ensures proper storage, transportation and archiving
• Assists with selection and management of external service providers in compliance with outsourcing strategy to ensure cost efficient and high quality services
• Leverages interactive response technology (IRT) system to support clinical supply management activities
• Authors/reviews critical study documents (e.g. study protocol, product dossiers, handling instructions, study reports)
• Leads or participates in global Clinical Trial Supply project meetings with internal and external team members
• Partners with R&D and other functions to ensure optimal use of systems and processes to support clinical trial supply chain
• Supports continuous improvements in clinical drug supply and revises SOPs to ensure ongoing compliance and efficient conduct of clinical trial supply activities

Minimum Qualifications

• Bachelors Degree in Life Sciences, Engineering, Logistics or equivalent experience
• 5+ years of experience in clinical supply management with the pharmaceutical industry
• Demonstrated knowledge of ICH-GCP regulations and the conduct of clinical studies
• Demonstrated knowledge of cGMP and cGDP regulations
• Team-player with proven effective interpersonal and communication skills