Beschreibung
Plans, establishes, manages, monitors activities related to trial supplies management, to support the clinical and pre-clinical drug development process, in cooperation with internal and external customers and partners in compliance with multinational regulations as well as internal procedures and GxP requirements.Your responsibilities
- Planning, creation and maintenance of study supply plans. Challenges and coordinates supply chain deliverables.
- Coordination the randomization, packaging, labeling and distribution of clinical supplies
- Establishing the packaging design and supply chain for clinical studies.
- Execution of supply forecast simulations.
- Establishes and manages CROs providing Packaging, Labeling and Distribution services.
- Manages the procurement, labeling and distribution of reference/comparator products.
- Milestone controlling: supply plan timelines to internal and external customers and partners.
- Participates in capacity and resource planning meetings.
- Using IVRS, contributes to the specification and performs medication management.
- Driving cross-functional activities: Cooperation with other line functions and external partners.
- Represents the Clinical Supplies at Clinical Trial Team and other applicable meetings.
- Participates in and supports internal/external inspections and audits.
Your Background
- Education: Degree in scientific or relevant discipline
- Languages: Fluent English (oral and written) required; fluent in German desirable
- 3 - 5 years experience in Clinical Supply Operations
- Organization and planning skills
- Communication, negotiation and interpersonal skills.
- Ability to strategically plan, organize and manage multiple projects simultaneously.
- Demonstrates track record of creativity and problem solving in projects.
- Demonstrates working knowledge of clinical supply systems and specialized tools including IVRS/ IRT.
- Knowledge of development activities and processes.
- Project management skills.
- Intermediate presentation skills.
- Ability to work in international and interdisciplinary teams.
- Knowledge of relevant GxPs as well as applicable multinational regulations.
- Experience in a Clinical Operations environment as a benefit.
Startdate: asap
Volume: full-time
Location: South Germany
Freelance or permanent employment!
Are you interested in this Project? Please deliver your CV in Word-Format.
I look forward reading our hearing from you,
Best regards,
Stefan Blöchl