Study Demand Planner

Job description

Job Description

The DSM Study Demand Planner (SDP) plans, drives and coordinates global Drug Supply Management(DSM) activities on a trial level for iDS studies for the lifetime of the trial (from planning, set-up, execution to close-out) to ensure the right drug always gets to the right patient on time. As business partner in the CTT (Clinical Trial Team) the SDP defines and advises the CTT on the optimal study supply strategy in terms of packaging design, technical and timeline feasibility, cost efficiency and risk management. The DSM SDP is also responsible to provide complete and accurate clinical trial demand information using defined DSM processes and systems.

Coordination of Drug Supply activities at Trial Level:
1. 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 pro-gress of deliverables adequately tracked. Maintains proactive communication with internal customers on trial changes and progress of deliverables.
2. Represents DSM as an active member of the CTT, ensuring clear communication and alignment between clinical needs and clinical supply planning.
3. Identifies, assesses and communicates risks to all relevant stakeholders (e.g. CTT, CDPM, etc) along with appropriate mitigation strategies to ensure supply continuity for all patients.

Specific Trial Management Activities:
4. Reviews clinical trial protocol and protocol amendments and provides input to drug supply sections. Develops optimal packaging design to match the study design and a supply plan optimized for cost, feasibility and overage.
5. Creates clinical demand plan for a trial based on trial requirements and maintains an accurate clinical demand forecast with appropriate overage based on changes in trial parameters. Defines a study level planning strategy in SAP in close collaboration with the Site Demand Planners (SiDPs), ensuring that the study and site forecasts are aligned. Evaluates planned versus actual study parameters and aligns accordingly with the CTT.
6. Creates and drives finalization of CPRs (Clinical Packaging Request).
7. Supports the Master Site Manager (MSM) in the set-up of NIRT (Novartis Interactive Response Technology) by providing input into the parameter sheet and randomization re-quest specifications, and creating the medication list.
8. Aligns with the SiDPs on the site replenishment strategy.
9. Creates and executes an optimal resupply strategy.
10. Manages shelf life planning on clinical finished good level and extensions of expiry dates and executes against plan to ensure supply continuity.
11. Actively participates in SDP platform activities and meetings, and supports the SDP team and others as required (e.g. as subject-matter-expert, in process improvement initia-tives, etc.).
12. Supports internal/external inspections and audits
13. Actively contributes to SOP creation, revisions and updates
14. Actively supports any additional tasks that may be assigned as documented in the Section below

Desired profile

Minimum requirements

Education:
Degree in science, engineering or equivalent.

Language:
English fluent in writing & spoken, second language desired

Professional Experience:
• >3 years of practical experience in chemical / pharmaceutical industry or > 3 years of experience in field of expertise
• Good organization and planning skills
• Good communication, negotiation and interpersonal skills.