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Job Details

Associate Clinical Operations Director

Company: RBW Consulting
Location:
Reference: DN-CH-CLINOPS25
Closing Date: 07 Sep 17
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

We are working in partnership with some of the most interesting companies in the market!

Requirements:

Introduction:

  • Leading and providing direction to the global cross-functional Clinical Trial Team to ensure all trial output from protocol development to final clinical study report (including archiving of the (e)Trial Master File) are delivered on time, within budget, and with highest achievable quality
  • Developing, updating, and ensuring adherence to agreed upon global trial budget

Main Responsibilities:

 

  • Leading and providing direction to the global cross-functional Clinical Trial Team to ensure all trial output from protocol development to final clinical study report (including archiving of the (e)Trial Master File) are delivered on time, within budget, and with highest achievable quality
  • Developing, updating, and ensuring adherence to agreed upon global trial budget
  • Representing the Clinical Trial Team at Clinical Project Team meetings
  • Chairing Clinical Trial Team meetings and ensure timely follow up of agreed upon actions
  • Ensuring adequate trial resources in personnel and material cross-functionally
  • Creating, maintaining, and updating the Clinical Trial Plan
  • Coordinating the development of trial-related core documents, such as the protocol, site guidelines, data management plan, statistical analysis plan, and clinical study report
  • Coordinating the development of specifications for external service providers in collaboration with Global Clinical Outsourcing and the Clinical Trial Team and ensure appropriate quality control of deliverables
  • Leading trial-related external meetings, e.g. Investigator meetings
  • Providing regular trial status updates (including critical issues and key performance indicators) and resolving issues at the Clinical Trial Team level in a proactive and timely fashion
  • Escalating unresolved issues
  • Coordinating pre-audit activities ensuring satisfactory outcome
  • Implementing best practices and lessons learned and share outcome with the teams
  • Assuming responsibility for other project or trial-related duties as assigned.

 

Qualifications and Experience:

  • Master’s degree or equivalent university education/degree in life sciences or healthcare
  • Minimum of 7 years relevant experience in clinical development and clinical trial management
  • Fluent in English; fluency in other languages is advantageous
  • Demonstrated expertise in global clinical research and development and project management (including risk management and contingency planning)
  • Advanced knowledge of International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) guidelines and other relevant clinical trial regulations
  • Demonstrated experience and leadership skills (e.g., leading project teams) working in global cross-functional (matrix) and multi-cultural teams
  • Experience in managing complex studies (e.g., large Phase III studies, difficult patient populations, external service providers)
  • Experience in executing a wide range of clinical trial activities (from initiation to clinical study report)
  • Experience selecting and managing external service providers
  • Good understanding of clinical trial budget/resource forecasting and management
  • Ability and willingness to perform some travelling internationally
  • Being responsible and accountable
  • Able to provide clear direction and coordinating action
  • Relevant working/residency permit or Swiss/EU-Citizenship required

 

Please contact me for further details.
 

With unrivalled industry knowledge and excellent links with hiring managers in Biotechs, Pharmas and CROs throughout the UK, Europe and across the world, we would be delighted to speak with you about the role you are looking for. Call +44 (0)1293 584 300 or email dominic.neal@rbwconsulting.com for a confidential discussion about your options for progression.

 

Keywords: 
Clinical Research Associate, CRA, Clinical Research, Clinical Research Scientist, International Monitoring, Project Manager, Clinical Project Manager, Clinical Project Director, Director of Clinical Operations, Clinical Study Manager, Oncology, CNS, Junior Project Manager, Lead CRA, Pharma, Biotech, International, CRO

Apply for this job: Associate Clinical Operations Director

Contact Information:

Address:  RBW Consulting LLP, Crawley, Zug Branch
Grabenstrasse 42, 6301 Zug, Switzerland

Switzerland
Tel:  0800896891
Website:  Visit Our Web Site

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