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Clinical Trial Manager (TM)

Eingestellt von Michael Bailey Associates - Munich

Gesuchte Skills: Design, Client

Projektbeschreibung

My client, a leading Pharmaceutical Company, situated inthe heart of Basel is looking for an experienced Global Clinical Trial Associate/Manager (dependent on experience).

Role Purpose:
The DSM Trial Manager (TM) plans, drives and coordinates global DSM activities on a trial level during study set-up, as well as for non-IRT studies during trial conduct, to ensure the right drug always gets to the right patient on time. As business partner in the CTT (Clinical Trial Team) the TM 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 TM 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 progress of deliverables adequately tracked. Maintains proactive communication with internal customers such as CDM, SCM, OM, CSDS and MDM 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 (eg CTT, CDPM, Order Alignment Meeting, 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.
6. Liaises with Clinical Supply Documentation Specialist (CSDS) to define an optimal label strategy according to study design, study timelines, participating countries and regulatory requirements.

Ideal Candidate:

BSc. Degree level education with proven industrial experience.

Preferred SAP experience

Project management, stakeholder management, communication

Fluent in English

Please send CVs or call

Michael Bailey International is acting as an Employment Business in relation to this vacancy.

Projektdetails

  • Einsatzort:

    Basel, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    18/03/2018

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    IT Entwicklung, Medien/Design

  • Skills:

    design, client

Michael Bailey Associates - Munich