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General information

Occupation: Full-time
Contract Type: CDD
Activity Domain: Medical, Health
Availability: No
Work Form: Ordinary
Language: English
Degree: No indication
Job Reference: No
Industry: No
Salary: Acura
Start Date: No
Duration: No
Salary Per: No
Benefits: No
Salary To: No
Salary From: No
Year of experience: No

Ad details

ObsEva is a clinical-stage biopharmaceutical company focused on the clinical development and commercialization of novel therapeutics for serious conditions that compromise a woman's reproductive health and pregnancy. Through strategic in-licensing and disciplined drug development, ObsEva has established a late-stage clinical pipeline with development programs focused on treating endometriosis, uterine fibroids, preterm labor and improving ART outcomes. For more information, please visit ObsEva.com.

 

ObsEva is recruiting, for its CMC team based in Geneva, a

 

Clinical Supply Manager

Reporting to the CMC Director, the Clinical Supply Manager will oversee activities related to ensuring drug supply management for all on-going and planned world-wide ObsEva clinical trials (Phase 1-3). The Clinical Supply Manager will be responsible for clinical trial supply planning, labeling, packaging, inventory management and distribution to ensure timely delivery of clinical supplies to clinical sites.

 

KEY TASKS & RESPONSIBILITIES

  • Manage clinical supply chain operations with outside CROs and CMOs including forecasting for all clinical trials, working closely and collaboratively with ObsEva Clinical Operations, Regulatory Affairs and other R&D functions to design appropriate planning, labeling, packaging and distribution configurations.
  • Coordinate outsourcing of labeling, packaging and on-time distribution of clinical trial supply to world-wide clinical sites: ensure the scheduling and timely delivery of all necessary clinical supply materials, such as bulk drug, label and packaging inserts, randomization schemes, packaging and shipping configurations, labeling and distribution plans of all ObsEva portfolio projects.
  • Ensure that all documentation concerning CTS (Labelling, packaging, distribution, reconciliation) is available complete and correct.
  • Ensure that all supplies are controlled and distributed in accordance with GMP, GLP, GCP and GDP regulations.
  • Interact with the Clinical CRO and IVRS on supplies, replenishments, returns and destructions.
  • Review and archive any blinded documentation until the end of the clinical study.
  • Monitor clinical trial supply management invoicing by CMO.
  • Represent clinical trial supply chain function on internal and external cross functional teams. 

Geolocation: Plan-les-Ouates, Switzerland
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