Job Description

Job Title: Trial Design Consultant (Cmed Technology)

Reports To: TBC

Department: Project management group

Core Responsibilities

Configuration of Third Phase databases (screen design, visit definition and validation programming) to quality specifications and agreed delivery timeframes.

Principal Accountabilities

• Creates screens, visit schedules according to annotated CRF and database specifications (for all types of database; Paper / eDC / Hybrid)


• Programs and tests validation checks (in Python) according to Data Management Plan (DMP) specifications


• Programs both generic and non-standard third party data loaders (in Python) according to study requirements (includes standard lab & ECG loaders, together with complex PD / PK and niche lab loaders)


• Represent department, as appropriate, in meetings, discussions and activities pertaining to Timaeus database configuration for assigned trials


• Provides input as appropriate into specifications of data structures and database applications to ensure adherence to the standards of the client or Cmed


• Provides input as appropriate into specifications of validation checks to ensure adherence to Cmed standards


• Maintains professional interfaces with internal and external customers in consultation with Cmed management


• Adheres to Cmed and/or project/study standards and database specifications


• Develop Cmed and/or sponsor standards to allow rapid accurate database configuration


• Maintains an up-to-date knowledge of new developments/functionality specific to database configuration of Timaeus as new versions are developed


• Contributes to departmental processes and procedures and takes part in/lead process initiatives as required by line manager


• Contributes to new starter mentorship and training as required by line manager


• Adheres to SOPs and WPs and ensures accurate and timely maintenance of documentation as required by such procedures


• Ensures timesheets are accurate and updated regularly.

Essential Work Experience And Qualifications

• Degree in life sciences, computer sciences, pharmacy, nursing or nursing qualification (e.g. RN) or equivalent relevant experience. A lower qualification may be accepted provided this is supplemented with relevant additional experience


• Qualifications as for Database programmer I plus previous experience (database experience OR clinical operations experience or at least 6 months experience at Database Programmer I level)


• Exposure to concepts of clinical database applications and platforms with a knowledge of eDM and eDC processes


• Foreign language skills would be advantageous

Attributes

• Good organisational skills, plus an understanding of resource & budgeting


• Good interpersonal and communication skills and the ability to operate effectively in a global working environment


• Work calmly under pressure and meet deadlines


• Professional, positive and enthusiastic attitude


• A good investigative and meticulous approach to all activities and tasks


• Transparent approach, clear and precise


• Team player


• Contribute to improving the effectiveness of the organisation such as developing new processes, systems and client relations


• Work effectively and efficiently with internal partners in Cmed