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Clinical Trial Operations Manager

Eingestellt von Michael Bailey Associates - Munich

Gesuchte Skills: Design

Projektbeschreibung

We are recruiting for a Trial Operations Manager for a global position within a multinational pharmaceutical company. You will be responsible for the oversight and coordination of the global monitoring operational aspects of assigned clinical trials, from start-up to close-out. This role is a great mix of strategic and operational duties where planning, feasibility assessment, trial allocation, start-up activities coordination, patient recruitment, clinical and delivery of data, sites close-out, audit and inspection preparation activities will be some of the main responsibilities.

RESPONSIBILITIES:

- Execute trials according to strategy inorder to achieve global and regional objectives.
- Participates in the development of innovative solutions in clinical trial planning and execution, including country, site and patient engagement to ensure the delivery of assigned studies on time
- Develops planning for prospective management of clinical trials including operational risks for each phase of the trial (Feasibility/allocation, Start-up, Data collection and cleaning) using available internal and external resources (patients' incidence, competitive landscape regional strategies, data, statistical plan)
- Drives conduct of medical and operational feasibilities and communicates aggregated feedback to clinical teams; supports protocol development; evaluates potential risks within the protocol and operational aspects of the study; assessing impacts, developing risk management plans and communicating/escalating, as appropriate
- Is accountable for recruitment activities; responsible for forecasting, setting up contingency planning to ensure recruitment targets are achieved in accordance with trial execution plan.
- Evaluates potential challenges/risks within the protocol and operational aspects of the study in line with the prevailing legislation, GCP, Ethical Committee, and SOP requirements; assessing impacts, developing risk management plans and communicating/escalating to appropriate stakeholder

REQUIREMENTS

- Advanced degree, preferably in life sciences
- Fluent English (oral and written)
- 3+ years' experience in clinical research, in planning/executing and/or monitoring clinical trials
- Solid understanding of all aspects of clinical drug development with particular emphasis on clinical trial design, trial execution, project management and operations
- Demonstrated ability to collaborate across partner functions in a Matrix environment, without direct reports, but can coordinate the activities of others
- Project/trial management and/or CRA or CRA management, Clinical Study Managers experience preferred
- Proven ability to manage operational challenges at global, regional or country level for large complex trials with minimal supervision
- Excellent project management capabilities with demonstrated ability to problem solve and mediate complex issues
- Understand and apply medical and business knowledge to clinical trial execution
- Excellent negotiation and conflict resolution skills

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:

    01/09/2019

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Medien/Design

  • Skills:

    design

Michael Bailey Associates - Munich