Job Description
Pay range: 37-47/hr
*depending on experience
Job Description:
• Application for material numbers for the packaging of clinical trial material and maintenance of material master data.
• Consultation of the global CTS study teams in the development of the packaging design of the studies as an expert for clinical trial packaging.
• Creation and maintenance of packaging plans taking clinical demand into account.
• Management of the inventory of all packaging components required in clinical studies.
• Ordering of materials considering delivery schedules.
• Creation of packaging orders in SAP and coordination of timely processes up to release with global departments.
• Application for and processing of kit lists required for the unique identification of each trial material container (e.g., bottle).
• Coordination of the global provision of samples for release testing after packaging.
• Ensuring that retention samples are taken from each packaging order and stored or later destroyed in accordance with regulatory requirements.
• Initiation and coordination of packaging reworks and relabeling (e.g., with new expiry date).
• Creation and maintenance of status reports on the packaging of clinical trial material.
• Creation of a study-specific label text template for all packaging units.
• Provision of translated and regulatory-compliant label texts for all clinical studies for submission to the authorities of the participating countries.
• Coordination of label printing with internal or external departments or service providers.
• Consultation of the global CTS study teams regarding the development of the label design.
• Collaboration with external service providers in maintaining a specific database for label text translations and regulatory requirements regarding label content.
• Support of other global departments (e.g., Global Commercial Development / Medical Affairs Organization) regarding the packaging and shipping of clinical trial material for IITs.
• Consultation of global departments regarding packaging design and delivery concept.
• Coordination with departments and service providers for the provision of translated label texts, printed labels, and other required packaging materials.
• Creation of packaging orders and ensuring timely delivery.
• Development, review, or revision of SOPs, forms, and templates related to the packaging and labeling of clinical trial material.
• Processing of Global Change Control requests
• Participation in the preparation of audits and inspections regarding trial material-related topics
• Processing of findings from audits and inspections
• Leading meetings with global CTS study teams to define the packaging and labeling strategy.
• Leading or participating in meetings with external service providers regarding packaging and labeling issues.
• Participation in global study team meetings and CTS meetings.
Minimum Required Qualifications:
• 2+ years' experience in clinical research and/or clinical supply management or global R&D project management in the pharmaceutical industry (3 preferred)
• Knowledge of ICH-GCP regulations and the conduct of clinical studies
• Knowledge of cGMP
Note: GxP knowledge is prioritized, SAP experience preferred. At least basic knowledge of clinical studies is expected. Must be flexible with working hours in order to allow for global collaboration (i.e. some early hours will be needed). Not a strategy/leading position, this is an execution/operational role. Responsibilities are limited to packaging and labeling, but knowledge of associated clinical study regulatory environment is highly preferred.
Job Tags
Contract work, Flexible hours,