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Clinical Data Programming Lead

Leuven
Permanent
Reference: 060674
Description

Due to an expansion with one of ICON's exciting key clients, we are currently looking to grow our EU Data Management team in Wavre, Belgium.

About Clinical Data Programming Lead at ICON:

In this central role, you will be responsible for the development of SDTM, SDTM +, SDTM annotated Case Report Form (CRF) and generation of SDTM datasets for various studies across all therapeutic areas. You will collaborate with the client and ICON team to define timelines, identify / resolve issues, produce deliverables in accordance with contractual commitments within budget. As a Clinical Data Programming Lead you can also function as a Team Lead for Programmers, ensuring team delivers to expected quality and timelines and providing technical oversight and training/mentoring.

Responsibilities:

  • Lead and execute programming deliverables on studies of high to moderate complexity in parallel and ensure that competing priorities are managed appropriately.
  • Lead and manage the assigned programming team's deliverables at the study and program level to ensure project objectives are met within budget, to agreed timelines and to the highest standard of quality.
  • Serve in a client-facing capacity that demonstrates the ability to anticipate client needs and implement innovative solutions, as appropriate.
  • Develop and foster client relationships through effective project management and communication.
  • Keep management informed of project status in relation to quality, timelines and/or performance issues.
  • Adhere to programming specifications and study specific requirements, including completion and filing of required documentation.
  • Plan, organize and prioritize workload to ensure effective time management and adherence to project specific timelines.
  • Efficient use of SAS including SAS® LSAF, and adherence to SAS programming guidelines.
  • Create and validate complex programs (such as project or departmental macros) to a high standard of quality and accuracy.
  • Set-up standard programming directories and start-up utilities.
  • Trouble-shoot and resolve programming issues in a timely and efficient manner.
  • Provide specifications for data models to be used for quality review and for final data model (SDTM or other); design mapping algorithms for non-standard conversions.
  • Ensure development of data transfer agreements with ancillary data vendors ensuring use of standards, fit-for purpose data models and transfer intervals
  • Ensure quality review of datasets (e.g., Pinnacle 21 compliance checking); ensure datasets are available for stakeholder use (medical review, central monitoring, adaptive design, etc) and compliant for Database lock.
  • Responsible for creation of submission-ready SDTM packages for FDA/PMDA or other regulatory authority submissions and keeping abreast in changing regulatory requirements
  • Proactively communicate and work effectively with the projects team including remote teams and with senior programming, management and sponsor personnel to achieve study goals.
  • Strive for excellence and act in a proactive and responsive manner to internal and client needs.
  • Demonstrate a constructive and flexible approach to project delivery, including problem solving, handling changing priorities and meeting study timelines.
  • Learn, share and apply new techniques and technologies to increase efficiency and to implement industry trend solutions.
  • Actively participate and contribute towards department initiatives, including sharing of knowledge, current literature reviews and process improvement.

To succeed you will need:

  • The successful individual will have proven experience in SDTM programming; possess a strong understanding of the principles of SDTM governance and be able to perform assigned tasks with minimum supervision.
  • Ability to successfully manage multiple tasks and timelines
  • Experience in SAS and SDTM
  • Team player with strong verbal and written communication skills
  • Demonstrated ability to learn new technologies
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