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Clinical Supply Chain Project Manager

Eingestellt von Harvey Nash IT Recruitment Belgium

Gesuchte Skills: Design, Support

Projektbeschreibung

One of our clients, an international company in the chemical industry currently requires a Clinical Supply Program Manager

Start: ASAP
Length: min. 12 months
Location: Brussels

Reviews the clinical trial protocols with regard to regulatory and GMP requirements, CMC issues and CTS aspects.

Scope of work:

The CSPM acts as a strong and visible partner for Technical/Clinical Development representatives, actively driving trial/packaging design and supply chain optimization, and ensuring full visibility of CTS on clinical development plans/compound information; (2) a program Matrix leader within CTS, overseeing trial supply execution & driving risk/budget management through other functions (in particular Clinical Supply Manager/Clinical Supply Associate).
Scope: All compounds and related clinical trials (phase 1-4) + Expanded Access Programs with CTS involvement

Major accountabilities are:

- Define and consolidate a supply strategy to ensure adequate and sufficient forecasting of drug product for assigned programs.
- Compile the forecasted trial budgets into a compound budget and provide regular updates through the budget exercises.
- CTS interface for the Technical Lead and Clinical Program Director/Lead Clinical Development Representative, fostering a close partnership, to:
- Represent CTS in CST (Clinical Satellite Team) meetings (or equivalent, potentially to be initiated by CSPM) and ensure CTS requirements and expectations are me and be able to influence decisions taken during those meetings.
- Represent CTS in TST (Technical Satellite Team) and address requirements for CMC related activities (eg development of formulation, stability program, shelf life extension etc.)
- Drive or suggest compound-level improvements/alignment within CTS or with Partners like Technical Leads and Clinical Program Directors
- Share key information/decisions/results from CST (Clinical Satellite Team) and TST (Technical Satellite Team) with other CTS functions Ensure availability of compound information and knowledge in CTS
- Lead and maintain structured oversight on clinical trials (forecasted and on-going) per compound to ensure no supply chain disruption and adequate budget, providing guidance and support to other CTS functions/Global Distribution & Logistics/QA as needed

Experience:

Master's degree in sciences and minimum of 5 years of CTS relevant experience (in pharmaceutical manufacturing/packaging, clinical trials and/or supply chain.

Specific skills

- Knowledge of GxPs
- Financial skills
- Project management
- Supply chain management
- Communication & Presentation skills (English fluency)
- Influence, negotiation, driving CTS visibility/impact
- Networking, collaboration
- Coaching, Matrix leadership, driving results through people
- Accountability
- Proactivity & Risk management
- Holistic/strategic thinking
- Creativity, innovation
- Problem solving

Priorities within next two years

- Partnership with Key Stakeholders, Drive Early/Formal Involvement
- End-to-End Optimization, Successful Patient Supply
- Patient Value Creation/Outside In Visibility: Study Dashboards & Change Management
- Drive implementation of new CSPM role (Technical Operations/Clinical Development Partner - Program Matrix leader):
- Owns/Shares compound & clinical development plan information
- Drives standardization/optimization/visibility/formalization
- Ensures CTS is leading/influencing in areas of expertise
- Owns trial design
- Oversees trial supply execution & drives risk/budget management (through delegation/dashboard/etc.)

Projektdetails

  • Einsatzort:

    Brussel, Belgien

  • Projektbeginn:

    asap

  • Projektdauer:

    12 months

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Harvey Nash IT Recruitment Belgium