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Clinical Trial Operations Opportunities at Parexel

Clinical Trial Operations

Statistical Design and Trials Supply Consultant

Job ID 58738BR Shanghai, Shanghai Municipality, China
Deliver a positive, memorable and meaningful service which exceeds the expectations of both the internal and external customer.

- Act as an internal consultant in advising and supporting study development. This includes:
• Assisting internally in the identification and implementation of preferred randomisation and medication management methods at the commencement of study design. Sign off the Project Requirements Specification. Review and sign off testing modules relating to area of specialism.
• Investigating and reporting on any non-compliances.
• Assisting PI personnel in problem analysis and resolution throughout the study development process and bringing to the attention of the relevant manager any circumstances causing concern.
• Providing internal training for medication management and randomisation at all levels and introduction to randomisation.
- Act as an external consultant, being responsible for:
• Providing clients with consultancy on the medication management configuration to be used during the study; recommendations will generally be made based on the expertise of the post holder.
• Assisting with ad hoc problem/issue resolution for won projects.

- Act as a trainer, coach and mentor as required.

Develop standards and maintain quality

• Where requested, assisting in periodically reviewing ‘Live‘ studies to ensure that they are performing correctly according to specification and client requirements.
• Providing advice to the SPSS team and the Operations Department to help ensure the integrity, security and quality of critical data.
• Contributing to continuous process improvement initiatives


Extra knowledge of the following can be an advantage, but not essential.
• Knowledge of regulatory guidance and published literature relevant to above
• SAS® Skills
• Access\\Excel skills (optional, depending on whether individual wishes to learn SAS)
o Able to produce cross-tabs
• Working knowledge of the simulation techniques

Qualifications

Skills:
Associate Statistical Design & Trial Supplies Consultant:
• Thorough knowledge of IRT randomisation and medication management techniques
• Prior knowledge of SAS® is not essential at this level. training provided to provide:
o Ability to amend existing programs by altering parameters or write simple SAS programs to perform activities as required. Programs may include simulations, data transfers, independent study and system testing and specialised consultancy activity
• Access\\Excel skills (optional, depending on whether individual wishes to learn SAS)
o Can create Access queries to interrogate databases for (e.g.) medication usage analysis and study queries
o Can perform manipulations of data in Excel (mean, min, max etc)
• Working knowledge of medication simulation for pre-study simulations
• Excellent interpersonal, verbal and written communication skills
• Client focused approach to work
• A flexible attitude with respect to work assignments and new learning


A scientific qualification can be a helpful background indicator of suitability.

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