Clinical Data Programming Lead

Employer
ICON Clinical Research
Location
Marlow
Salary
Competitive
Closing date
21 Sep 2020

View more

Discipline
Data Management / Statistics, Clinical Data Management
Hours
Full Time
Contract Type
Permanent
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In this role, you will be responsible for performing CDMS Programming activities as related to building study databases, programming edit checks and configuring other system features. As a Clinical Data Programming Lead you can also function as a Team Lead for CDMS Programmers, ensuring the team delivers to expected quality and timelines and providing technical oversight and training/mentoring.

Responsibilities:

• Performs study specific database set-up using Medidata Rave.

• Reviews database specification documents created by study teams, such as CRF Specifications and Data Validation Specifications (DVS).

• Creates/Programs edit checks, special actions, custom functions and derivations as per a DVS.

• Works closely with centralized CDMS Testing Group to ensure all programming issues are resolved in a timely manner and study timelines are met.

• Trouble-shoots and solves study building issues and edit check programming issues.

• Set up of Coder, IRT, T-SDV and Rave Safety Gateway integrations may be required.

• Run Screen Review Meetings with sponsors and act as point of contact for all Rave questions.

- Serves as Team lead to CDMS Programmers on assigned studies; providing training, best practices, support and quality checks on study build and programming.

- May be asked to extend technical expertise and mentor team members on an ongoing basis; ensure team achieves productivity and quality targets, perform oversight of deliverables using different tools/techniques and report relevant metrics. Contributes to training materials on a process, system or technology level.

To succeed you will need:

The successful individual will have a proven experience in study build set up; possess a strong understanding of the principles of system development lifecycle and be able to perform assigned tasks with minimum supervision.

The requirements listed below are representative of the knowledge, skill, and/or ability required:

• Prior relevant experience in building study databases

• Ability to successfully manage multiple tasks and timelines

• Proficiency in Medidata Rave

• Team player with strong verbal and written communication skills

• Demonstrated ability to learn new technologies, applications and techniques

• Ability to interpret study protocols into database design

• Understanding of database concepts

• Understanding of CDISC (CDASH/SDTM) standards

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life.

We are a global provider of outsourced development and commercialisation services to pharmaceuticalbiotechnologymedical device and government and public health organisations. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas. ICON has been recognised as one of the world’s leading Contract Research Organisations through a number of high-profile industry awards.

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Contact Us
  • 3rd Floor
  • Marlow International
  • Marlow
  • SL7 1YL
  • United Kingdom
  • 01628 496300
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