| || He/She is generally assigned to studies using an IRT system and is responsible for the IRT set-up and maintenance for DSM. The CDM creates and maintains the distribution plan during the lifetime of an IRT study based on the actual study conduct, and periodically reviews and adapts the distribution strategy and IRT parameters to ensure availability of clinical supplies to support the treatment of patients and to optimize distribution costs. The CDM plans, drives and coordinates global DSM activities on a trial level after hand-over from the Trial Manager (TM) after trial RIS to ensure the right drug always gets to the right patient on time. As business partner in the Clinical Trial Team (CTT) after hand-over from the TM, a CDM defines and advises the CTT on the optimal resupply/relabeling strategy and adapts trial planning as required. The CDM is also responsible to maintain complete and accurate clinical trial demand information using defined DSM processes and systems.
1. After study start and hand-over from the DSM TM, coordinates trial deliverables within DSM and all other relevant associated functions. Ensures that a trial-level project plan is developed together with all relevant roles and progress of deliverables adequately tracked. Maintains proactive communication with internal customers. 2. After study start and hand-over from the DSM TM, represents DSM as an active member of the CTT, ensuring clear communication and alignment between clinical needs and clinical supply planning. 3. Prior to RIS, identifies, assesses and communicates risks together with potential and appropriate mitigation strategies for IRT set-up and distribution of supplies to the DSM TM. Post RIS and after hand-over from the DSM TM, identifies, assesses and communicates risks to all relevant stakeholders along with appropriate mitigation strategies to ensure supply continuity for all patients. 4. Defines a study’s IRT user requirement specifications. Reviews and updates IRT supply parameters periodically over study lifetime to ensure availability of clinical supplies based on actual study conduct, optimize overage and distribution costs. 5. Generates optimal distribution plans for investigational medicinal products considering aspects such as optimal lot size, costs and overages. Triggers and tracks shipments of clinical trial supplies from central depot to regional hubs and local depots. Follows-up with distribution vendors and local hub/depot contacts, as needed. 6. Creates and executes an optimal resupply strategy. 7. Manages shelf life planning on clinical finished good level and extensions of expiry dates and executes against plan to ensure supply continuity. 8. Forecasts and updates distribution budget; provides distribution cost input for Grant application, requests PO and ensures invoices are received and approved on time. 9. Reviews clinical trial protocol amendments and provides input to drug supply sections. 10. Updates the clinical demand plan for a trial and maintains an accurate clinical demand forecast with appropriate overage based on changes in trial parameters. 11. Liaises with Clinical Label Management (CLM) to amend the label strategy according to changes in study design, study timelines, participating countries and regulatory requirements. Creates and drives finalization of clinical packaging request after RIS. 12. Actively participates in CDM Forums activities and supports CDM Forum Lead as required.
| || Degree in science, engineering or equivalent Fluent in English (Read, Write and Speak) 1. > 6 years of practical experience in chemical/ pharmaceutical industry or in field of expertise 2. Good knowledge and understanding of global drug development and clinical operations 3. SAP experience preferred 4. Excellent project management, organization, planning skills 5. Strong knowledge of relevant regulatory experience (e.g. GMP, HSE, etc.) 6. Demonstrate cross-functional problems and idea generation skills |