Clinical Data Programmer

• Design and set-up of study database for data collection in clinical trials based on protocol needs
• Responsible for Central Designer Programming testing, validation and execution by following the defined process
• Focuses on business value, establishes the boundary of the feature’s scope and guides development
• Active participation in sharing better practices on use of standards in alignment with Lead Clinical Data Programmer and Process & Automation Specialist.
• Maintain system related documentation.
• Facilitate implementation of business processes introduced by the systems supported by DaMaSys (Data Management Systems & Standards). Design, Programming and validate programs to check data accuracy and aid report generation.

• General responsibilities

  • Be compliant on SOPs, GCP, GDP and GPP (good programming practice).
  • Collaborate with trial teams to agree/negotiate on timelines.
  • Promote the exchange of know-how within the organization via participations in share better practice sessions and trial related meetings.
  • Contribute to the generation of a co-operative and collegial atmosphere within the department.
  • Report regular status updates to Manager.

  Design and set-up of study database for data collection in clinical trials based on protocol needs

  • Create trial in central designer for set up of trial database and activate the database upon approval from relevant stakeholders.
  • Apply or copy global validation/derivation checks, build trial specific checks and perform testing
  • Serve as programming contact to handle database issues within expertise area.
  • Review and provide inputs to requirements in relation but not limited to protocol, flow chart etc.
  • Review and provide inputs to Project plan and any other documents based on trial and process requirement.
  • Create and maintain relevant documents as per TMF's (Trial Master File) ToC (Table of Contents).
  • Strong understanding of different types of validation checks and proficiency in creating test case scenarios.
  • Perform the testing before deployed into production and document pass and fail scenarios in a timely manner.
  • Timely program the Dynamic checks, Display Overrides as per the requirement and perform unit testing
  • Perform post production changes.
  • Review UAT (User Acceptance testing) for checking the quality of database.
  • Review test case and results from UAT (User Acceptance Testing).
  • Maintain/update testing related documentation.

  Responsible for Central Designer Programming testing, validation and execution by following the defined process

  • Understanding of Central Designer platform on layout, typography, and other design principles
  Own end-to-end flows and experiences that delight and create value for trials across different portfolio
  • Provide input to Central Designer pre-requirement documents consisting of edit checks, dynamics, Display Overrides, constants. etc
  • Perform the test of scenarios listed in the test plan to see if they work properly before deployment
  • Determine if assigned scenarios pass or fail and record findings timely
  • Communicate suggestions or concerns regarding testing with relevant stakeholders

  Focuses on business value, establishes the boundary of the feature’s scope and guides development

  • Review Rule scoping/estimations of timelines for edit check programming
  • Design and Programming the trial specific EC, and calculation rules based on finalized Edit check requirement document
  • Ensure timely InForm Go-Live
  • Support in good system performance confirming project specific libraries to guarantee consistency and efficiency.
  • Offer technical expertise for internal and external stakeholders.
  • Knowledge of CDASH standards.

  Active participation in sharing better practices on use of standards in alignment with Lead Clinical Da-ta Programmer and Process & Automation Specialist

  • Share trial learnings along with impact analysis with line manager and team.
  • Ensure the learnings are implemented to forthcoming trials / projects.
  • Ensure that the newest knowledge is collected and shared with relevant stakeholders including super users in Clinical & Data Science on database set-up
  • Support communication around methods and standards in Clinical & Data Science
  • Give input to internal workshops and seminars.
  • Advise and assist co-workers when needed.

  Maintain system related documentation

  • Update documentation related to the system as appropriate.
  • Give input to optimisation of documentation related to the system.

  Facilitate implementation of business processes introduced by the systems supported by DaMaSys (Data Management Systems & Standards)

  • Give input to optimisation of processes related to / connected with the use of the systems.
  • Assist in relevant change management activities.
  • Responsible for continuously improving way of working in close collaboration with the other departments in Data Management Systems & Standards and their stakeholders.
  • Facilitate update to relevant processes and documents.
  • Be enablers of timely and fit-for-purpose products.

  Design, Programming and validate programs to check data accuracy and aid report generation

  • Perform QC by using relevant UAT reports.

You are:

• Key stakeholders

  Type of communication

  ·       Internal Stakeholders ·       ·       TDM Community (Clinical Trial Data Manager, Project Data Manager) ·       Biostat community (International Lead programmers, Trial Programmers, Statisticians) ·       Data Management Systems & Standards ·       Global IT ·       Centralised Monitoring Unit ·       ·       External stakeholders ·       Vendors / CROs

  ·       Communication is a very important element of the job and requires: ·     Collaboration within the team to resolve technical issues. ·     Frequent contact with colleagues from other departments to co-ordinate activities, and to reach agreement on conflicting options and/or opinions. ·     Share better practices across data flow value chain via agile SBPs, trainings etc. ·     The ability to listen, understand other points of view and handle conflicting opinions respectfully. ·     Oral and Written documentation is required to reach agreements. ·     Presentations, Training Material and other written documentation may be required as well.

  Knowledge, skills and experience:
  Education:	M.Sc / B.Sc in Life Science or comparable degree in computer science, Information Technology clinical information management or equivalent qualifications.
  Experience:	·       Minimum 3-5 years of experience in pharmaceutical industry and preferably 2 years within clinical data management and hands on experience in CDASH, CDISC requirements. ·       Good experience on end-to-end clinical data management activities. ·       Good knowledge of clinical systems and preferable experience in programming languages (eg: SAS/SQL/R/Python, Jupyter etc). Requires basic knowledge on AI & ML to be part automation/innovation initiatives within and across the departments. ·       Knowledge with analysis and design of business processes within the area of drug development. ·       Experience with collaboration across professional and regional borders. ·       Good project management experience. ·       Profound knowledge of GxP and guidelines within drug development. ·       Fluency in written/spoken English and good presentation skills ·       Team oriented personality with a high degree of flexibility ·       Quality mind-set and strong analytical skills.
  Personal skills:	·       Tasks are, to a large extent, to be performed independently and in accordance with Client’s SOPs/policies and the Client’s Way. ·       A variety of tasks must be performed simultaneously; the tools used are technically advanced; and, often, only general guidelines are available. Consequently, a great deal of knowledge is demanded. Additionally, sound understanding of related tasks is necessary. ·       Owing to regulatory requests, newly discovered clinical implications and business opportunities, the priorities of activities change frequently. The Clinical Data programmer-EDC has a direct business impact on the critical time used for getting new drugs to the market and the quality of the work performed. Thus, the tasks carried out strongly affects the business results of Client. The pressure and stress of the position can be considerable and requires stable and flexible staff. General Skills ·         Fluency in written and spoken English. ·         Ability to work in a diverse multi-cultural environment. ·         Committed and responsible. ·         Proactive and solution-oriented approach to challenges. ·         Team oriented personality with a high degree of flexibility. ·         Planning / Co-ordinating abilities. ·         Quality mind-set and strong analytical skills. Soft Skills: ·            Lives up to clients values: accountable, ambitious, responsible, and engaged with stakeholders, open and honest and ready for change.

Why ICON?Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.