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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, in collaboration with GCT/ICT/CTTs, regions and countries (COs). 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.

Please note that this is a contract position until the end of the year and renewed yearly from then on.

Responsibilities:

- In compliance with GPT/GCT/ICT/CTT you will execute trials according to plans and timeline, commitments in alignment with Trial Monitoring strategy and on behalf of the Trial Monitoring organization to achieve global and regional objectives.
- Communicates planned milestones to Trial Monitoring stakeholders and update GCT/ICT/CTTs on operational activities at the Region/Country level, during the course of the trials to meet GPT 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
- Is a core member of the assigned TOM Development Unit Team
- Actively participates in the development of reporting methodologies, and implements performance reporting for trial monitoring, ensures accurate and complete operational data within corporate systems (ie CTMS, IMPACT).
- Is responsible to have trials execution according to enrolment commitment and timelines delivered per established GDD key performance indicators.

Requirements

o Advanced degree, preferably in life sciences

o Fluent English (oral and written)

o 5 to 8 years' experience in clinical research, in planning/executing and/or monitoring clinical trials

o Solid understanding of all aspects of clinical drug development with particular emphasis on clinical trial design, trial execution, project management and operations

o Demonstrated ability to collaborate across partner functions in a Matrix environment, without direct reports, but can coordinate the activities of others

o Project/trial management and/or CRA or CRA management, Clinical Study Managers experience preferred

o Proven ability to manage operational challenges at global, regional or country level for large complex trials with minimal supervision

o Excellent project management capabilities with demonstrated ability to problem solve and mediate complex issues

o Thorough knowledge of the international aspects of drug development process, the international standards (GCP/ICH), health authorities (FDA/EMEA), local/National health authorities regulations.

o Understand and apply medical and business knowledge to clinical trial execution

o Excellent negotiation and conflict resolution skills

Please send CVs or call for more information and a more detailed Job Description.

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

Projektdetails

  • Einsatzort:

    Basel, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    12/2018

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Medien/Design

  • Skills:

    design

Michael Bailey Associates - Munich