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Clinical Trial Supply Manager (Ref. Nr.: EW2548)

Eingestellt von BRINE SA

Gesuchte Skills: Design, Consultants

Projektbeschreibung

CLINICAL TRIAL SUPPLY MANAGER

BRINE SA has been placing top IT specialists at well-known customers for over 30 years. In doing so, we focus on performance, competence, experience and partnerships.

We are offering a position to a candidate with following experience:

ROLE DESCRIPTION:

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The 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.
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The CTSM is the single point of contact in GCS (Global Clinical Supply) at trial level for the integrated Clinical Trial Team (iCTT).
- Is responsible for clinical trial supply deliverables within GCS and all other relevant associated sub-functions, maintaining Quality and Compliance through all activities.
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Has operational end to end responsibility for assigned activity.
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Leads and manages all project and local network activities and participates in cross-functional Teams.

MAJOR ACCOUNTABILITIES:

1. 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.

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 projections, 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 throughout 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 timelines (including INDIMPD 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, appropriate lead-time and replenishment quantities to ensure compliance and continuity of clinical 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 GCS external cost (eg labels, packaging, distribution and comparators).

12. 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.

13. Fully supports, prepares the GCS PL to adequately address GCS considerations at various cross-functional teams eg TRD sub team, ICT, etc.

MINIMUM REQUIREMENTS:

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University degree in science, engineering or equivalent. Fluent in English
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Min. 5 years of practical experience in chemical/pharmaceutical industry, min. 3 years of experience in field of expertise
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Good expertise in related field.
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Good knowledge about the Drug Development process
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Basic project management, good organization and planning skills
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Knowledge of relevant regulations (eg GMP, HSE etc.)
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Demonstrates problem-solving and idea generation skills
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Good presentation skills
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Fundamental Leadership skills.
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Very good communication, negotiation and interpersonal skills.
- Ability to work in interdisciplinary teams.

To learn more about this opportunity please send your CV ASAP in Word format to Brine SA.

WORK LOCATION: Basel

START: ASAP

DURATION: till 25.11.2019

WORKLOAD: 100%

SALARY: Local Market rate according to experience

PERMIT: EU permits

LANGUAGE: English

REF. NR.: EW2548

BRINE SA has been providing its IT- and SAP specialists for short-, mid- and long-term projects in Switzerland since 1985, with customers primarily active in the following market sectors:

Financial services sector, especially banks and insurance companies

Pharmaceutical industry

Government and services sectors

BRINE SA is a stable, financially independent, Swiss enterprise with its head office in Zurich. Our services cover the entire IT spectrum, as well as interfaces to the various business sectors, and range from management- and IT-consulting through to software development and project implementation.

IT - RESOURCES

We offer our top consultants, computer Profi's and SAP experts to our customers as external specialists for limited assignments and as well for permanent positions.

BRINE SA is especially distinguished by its renowned characteristic strengths:

Short reaction time - rapid selection and supply of consultant's CVs, with skills matched to customer requirements.

Quality - we take quality very seriously, both for internal and external-facing processes, thereby convincing many customers to maintain a long-standing business relationship with BRINE SA

Coaching - BRINE SA coaches and supports its consultants throughout the entire duration of the customer assignment.

BRINE SA is ISO 9001:2008 certified since 2014

Projektdetails

  • Einsatzort:

    Basel, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    1 Year

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

BRINE SA