Clinical Trial Supply Manager in GCS

vor 1 Woche

Basel, Schweiz WillHire Vollzeit

This is a temporary contractor opportunity at Novartis

Novartis touches the lives of a tenth of the world’s population. Every role here, regardless of contract type, makes an impact on human life

Novartis partners with external managed service provider Magnit Global to offer engaging temporary contractor opportunities like this, to those who are looking for flexibility in their career while looking to gain new skills and experiences providing services to an inclusive global medicines company.

Ready to work with/through Magnit at Novartis? Please read on...

Responsibilities in brief:

  • Project/Study managers will be responsible for study supply leadership to ensure timely planning and execution of supply strategy for continued supply of clinical finished goods (supply drugs) to patients.
  • Study managers provide inputs in clinical study protocol, understand study design and are responsible for optimal clinical trial supply strategy in terms of packaging design, proactive planning following a risk-based approach.
  • Represent Global Clinical Supply as a single point of contact (SPOC) at trial level for the integrated Clinical Trial team (iCTT).

Major accountabilities:

  • Represents GCS 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.
  • Reviews overall clinical trial protocol/protocol amendments, provides inputs to develop optimal packaging design, clinical trial supply design and visit schedule.
  • Creates and maintains complete and accurate clinical supply demand for assigned study in alignment with protocol requirements, key study parameters and milestones, patient projections, with appropriate overage and by using defined processes and systems.
  • Creates and drives finalization of the packaging design (Clinical Packaging Request) and a comprehensive label strategy for all participating countries in the clinical trial.
  • Defines clinical supply parameters for NIRT set up and initiates subsequent updates throughout the duration of the clinical trial.
  • Develops and executes a trial-level project plan together with all other relevant roles.
  • Identifies, assesses and proactively communicates supply risks to all relevant stakeholders along with appropriate mitigation strategies to ensure supply continuity.
  • Collaborates with all relevant line function partners for country submission and approval timelines (including INDIMPD amendment) to develop optimal supply strategy.
  • 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.
  • Develops, maintains and executes an optimal resupply strategy with proactive planning, appropriate lead-time and replenishment quantities to ensure compliance and continuity of clinical supplies, including proactive expiry management of clinical supplies.
  • Is responsible to consolidate, maintain and track the clinical trial budget with key stakeholders for overall GCS external cost (e.g. labels, packaging, distribution and comparators).
  • Actively contributes to the GCS sub-team as a full member. Ensures adequate, proactive exchange of relevant knowledge & information between the GCS sub team and the CTT.
  • Fully supports, prepares the GCS PL to adequately address GCS considerations at various cross-functional teams e.g. TRD sub team, ICT, etc.

Attributes/Competencies required for this global role:

  • Accountability and leadership.
  • IRT (Interactive Response Technology) system perfect knowledge.
  • Self-awareness: Open to seek and receive feedback, having the right attitude.
  • Operational & Project excellence: Proactive in study planning and assigned portfolio, ensures robust risk management (identification and mitigation of risks) and various scenarios to support decision-making process.
  • Stakeholder management & Interpersonal skills: Able to engage, influence, align and lead internal and external business partners.
  • Communication Skills & Business mindset: Able to communicate effectively with different audiences.
  • Managing Change: Ability to rebound from setbacks and adversity when facing difficult situations.

Ideal Background:

  • Min. 5 years of practical experience in clinical supplies within the pharmaceutical industry.
  • Strong operational excellence with high attention to details.
  • Advanced project management, good organization and planning skills.
  • Broad technical knowledge in appropriate Supply Chain systems used for forecasting and demand planning (min 3 years of experience with SAP).
  • Data & Digital savviness with high learning ability.
  • Knowledge of relevant regulations (e.g GMP, HSE etc...) and Novartis specific standards.

Workload: 100% (40 hours per week)

Role type: Onsite

Estimated start date: April 2025

Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us

Commitment to Diversity and Inclusion / EEO: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

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