Global Project/study manager in Clinical Supply Chain

vor 15 Stunden

Basel, Basel-Stadt, Schweiz Hays Vollzeit

We are looking to hire talent for a
Global project management role in Clinical Supply Chain
for one of our Pharma clients.

Responsibilities in brief:

  • As the
    Project/Study manager, you will be responsible for study supply leadersh
    ip to ensure timely planning and execution of supply strategy for continued supply of
    clinical finished goods (supply drugs) to patients
  • Provide
    input in clinical study protocol, understand study design and are responsible for optimal clinical trial supply strategy in terms of packaging design, pro- active 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 subteam 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.

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...)

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