DSM Clinical Trial Supply Manager (CTSM) defines and executes an optimal clinical trial supply strategy for a clinical trial including effective risk management to ensure supply continuity to patients.
The CTSM is the DSM single point of contact at trial level for the integrated Clinical Trial Team (iCTT). Is responsible for clinical trial supply deliverables within DSM and all other relevant associated sub-functions, maintaining Quality and Compliance through all activities.
Has operational end to end responsibility for assigned activity. Leads and manages all project and local network activities and participates in cross-functional teams.
1.Represents DSM as a core member in the integrated Clinical Trial Team (iCTT); defines and advises the iCTT on the optimal clinical trial supply strategy in terms of, but not limited to, packaging design, technical and timeline feasibility, efficiency and risk management.
2.Reviews overall clinical trial protocol/protocol amendments, provides inputs to develop optimal packaging design, clinical trial supply design and visit schedule.
3.Creates and maintains complete and accurate clinical supply demand for assigned study in alignment with protocol requirements, key study parameters and milestones, patient projec-tions, with appropriate overage and by using defined processes and systems.
4.Creates and drives finalization of the packaging design (Clinical Packaging Request) and a comprehensive label strategy for all participating countries in the clinical trial.
5.Defines clinical supply parameters for NIRT set up and initiates subsequent updates through-out the duration of the clinical trial
6.Develops and executes a trial-level project plan together with all other relevant roles.
7.Identifies, assesses and proactively communicates supply risks to all relevant stakeholders along with appropriate mitigation strategies to ensure supply continuity
8.Collaborates with all relevant line function partners for country submission and approval time-lines (including IND-IMPD amendment) to develop optimal supply strategy.
9.Generates optimal distribution plans for investigational medicinal products (IMPs), jointly with partner functions. Triggers and tracks shipments of IMPs from central depot to regional hubs and local depots.
10.Develops, maintains and executes an optimal resupply strategy with proactive planning, ap-propriate lead-time and replenishment quantities to ensure compliance and continuity of clini-cal supplies, including proactive expiry management of clinical supplies.
11.Is responsible to consolidate, maintain and track the clinical trial budget with key stakeholders for overall DSM external cost (e.g. labels, packaging, distribution and comparators).
12.Actively contributes to the DSM subteam as a full member. Ensures adequate, proactive ex-change of relevant knowledge & information between the DSM sub team and the CTT.
13.Fully supports, prepares the DSM PL to adequately address DSM-considerations at various cross-functional teams e.g. TRD sub team, ICT, etc.
1.Ensure compliance of processes with regulations as well as Novartis internal procedures and GxP requirements.
2.Actively participate in teams activities and fulfill all related tasks and responsibilities related to own discipline.
3.Proactively communicate key issues and any critical topic in a timely manner to the appropriate management level and to/or any other relevant project team members. Interpret results, evaluate data, draw conclusions and report back to team and management.
4.Give guidance to team members. Provide coaching and technical training as subject matter expert or recognized technical expert. Act as mentor for junior and senior associates.
5.Actively contribute to team goals.
6.Monitor and report Key Performance Indicators (KPI) and performance measures to enable strate-gic objectives to be met, or corrective action to be taken.
7.Execute the activities part of the strategic plan.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Degree in science, engineering or equivalent.
1.>5 years of practical experience in chemical / pharmaceutical industry or > 3 years of experience in field of expertise
2.Good expertise in related field.
3.Good knowledge about the Drug Development process
4.Basic project management , good organization and planning skills
5.Knowledge of relevant regulations (e.g. GMP, HSE etc.) and Novartis specific standards.
6.Demonstrates problem-solving and idea generation skills
7.Good presentation skills
8.Fundamental Leadership skills.
9.Very good communication, negotiation and interpersonal skills. Ability to work in interdisciplinary teams.
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