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Expert Clinical Manager

Eingestellt von Harvey Nash IT Recruitment Switzerland

Projektbeschreibung

Harvey Nash is looking for an Expert Clinical Manager for a 6 month project in Switzerland.

The candidate is responsible for all operational aspects of 1 or more OGD clinical trial(s) under the leadership of Clinical Trial Head (CTH) and for supporting all scientific aspects of clinical trial(s) as assigned.

You are responsible for
- Ensuring all operational trial deliverables are met according to timelines, budget, operational procedures and quality standards
- Providing input and contribute to the development of protocols and related documents, in the ongoing scientific review of clinical data, and in trial data analysis, reporting and publishing
- Preparing training materials and presentations related to the planning and conduct of the trial
- Preparing clinical outsourcing specifications and for management of Contract ResearchOrganizations ( CROs) and ensuring adherence to scope of work within timelines and budget
- Managing interactions with Oncology Development Operations and other relevant functions including Drug Supply Management and local medical organizations
- accuracy of trial information in all trial databases and tracking systems
- Supporting the development, management and tracking of trial budget working closely with the appropriate partners in OGD
- Participating in the organization and logistics of various oversight and Advisory boards; attend meetings
- managing/answering questions related to trial procedures and patients' eligibility
- Writing CTT meeting minutes, occasionally deputizing for the CTH at Clinical Trial Team meetings and participating in International Clinical Team meetings
- Contributing to program level activities (eg, tracking of OGD program-related publications, development of clinical sections of regulatory documents like Investigators' Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions)
- implementation of best practices and standards for trial management within the TA, including sharing lessons learned
- Contributing to talent and career development of OGD staff through active participation in on- boarding, training and mentoring activities and serving as faculty member for OGD training programs

Requirements

- Advanced degree or equivalent education/degree in life science/healthcare required accompanied with = 2 years experience in clinical research or Bachelor degree or equivalent education/degree in life science/healthcare required if accompanied with = 4 years experience in clinical
- Involvement in cross-functional, multicultural and international clinical trial teams; demonstrated capabilities in leading specific trial related activities like planning, executing, reporting and publishing activities
- Excellent communication, organization and tracking skills. Strong operational skills and demonstrated ability to meet timelines
- Proven networking skills and ability to train colleagues
- Proven ability to work both independently or in a team setting, including a Matrix environment
- Knowledge of Good Clinical Practice; thorough knowledge of clinical trial design; understanding of the overall drug development process
- Knowledge of principles for trial budgeting.
- Basic knowledge of oncology and/or hematology preferable
- Fluent English (oral and written)

Are you available immediately, have experience working within a Life Science company? Please send your complete CV (Word documents preferred)

Projektdetails

  • Einsatzort:

    Basel, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    6 months

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Sonstiges

Harvey Nash IT Recruitment Switzerland