Clinical Supplies Manager, 100%, 6+ months, on site

Beschreibung

Aktuell suchen wir für ein international renommiertes Pharmaunternehmen einen Interim Clinical Trial Supplies Manager mit eingehender Praxiserfahrung.

Tasks:

Leads the planning, creation and maintenance of study supply plans, based on protocol synopses. Challenges and coordinates supply chain deliverables.

Establishes the packaging design and supply chain for clinical studies.

Executes supply forecast simulations.

Coordinates the randomization, packaging, labeling and distribution of clinical supplies according to study supply plan.

Establishes and manages third party CROs providing Packaging, Labeling and Distribution services.

Manages the procurement, labeling and distribution of reference/comparator products.

Ensures that key study milestones are met; negotiates and communicates supply plan timelines to internal and external customers and partners.

For studies using IVRS, contributes to the specification and performs medication management.

Proactively drives cross-functional activities. Works with other line functions and external partners to manage studies.

Participates in capacity and resource planning.

Acts as the Clinical Supplies representative at Clinical Trial Team and other applicable meetings.

Participates in and supports internal/external inspections and audits.

Drives integrated project management with external partner.

Provides Clinical Supplies external costs for budgeting purposes and provides input on actuals.

Requirements:

3 - 5 years relevant experience Clinical Supply Operations, Clinical Supply Project Management or Related Field.

Intermediate organization, planning and leadership skills.

Intermediate 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.

Intermediate knowledge of development activities and processes.

Intermediate project management skills.

Intermediate presentation skills.

Ability to work in interdisciplinary teams.

Knowledge of relevant GxPs as well as applicable multinational regulations.

Experience in a Clinical Operations environment would be advantageous.

Volumen: 100% (40h / Woche)

Laufzeit: 6+ Monate

Start: ASAP (nach Vereinbarung)

Ort: Süddeutschland

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