Clinical Data Management EDC Specialist (RAVE)

IDDI (International Drug Development Institute), founded in 1991, is a highly recognized biostatistical and eClinical service provider in the field of clinical research. Together, we want to achieve one objective: support our clients to accelerate the delivery of their drugs and improve people’s health.

To support our growth, we are actively looking for a Clinical Data Management EDC (Electronic Data Capture) Specialist to reinforce our team in the US (Raleigh, North Carolina).

Clinical Data Management EDC Specialist (RAVE)

Your role:

In collaboration with Lead Clinical Data Managers, you are responsible for the Electronic Data Capture (EDC) setup (including eCRF design, EDC display, edit checks, EDC reports) in projects related to various therapeutics areas.

You participate to cross-functional teams meetings with client’s representatives to  provide guidance and, with them, you define the best set up approach for their study.

While you ensure high quality in your daily activities, you also contribute in initiatives to continuously enhance efficiency of the EDC system and propose innovative solutions within your area of expertise.

You are fully involved in the review of the team processes (including SOPs, working instructions update) and ensure improvements. Based on your experience, you will also actively act in the user acceptance testing of the EDC system.

You will be part of a dynamic and experienced team. You will report directly to the Team Leader EDC Specialists. To help you thrive in your role and develop further your career, you will receive the necessary trainings, mentoring and coaching from your peers.

Your responsibilities will be:

  • Design Electronic CRFs according to the data collection requirements of protocols
  • Create the edit-checks included in the Data Validation Plan, in collaboration with the Lead CDM
  • Communicate with sponsors and other project stakeholders regarding EDC set up progress
  • Review EDC specifications
  • Review Web Service Specifications
  • Develop study related key documentation according to Standard Operating Procedures (SOPs)
  • Maintain the study-specific EDC system implementation according to study needs
  • Participating in the development of standardization templates and processes

Your profile:

  • Bachelor or Master’s Degree in health related field or computer sciences
  • RAVE architect Builder certification (reference will be requested)
  • Experience in Clinical Data Management
  • Knowledge in CDISC CDASH is an asset
  • Demonstrated programming skills (C#, SQL, or similar programming experience highly desirable).
  • Fluent in English with good communication skills, both oral and written
  • Good time management skills
  • You are curious and like to challenge the status quo
  • High attention to detail
  • Demonstrated ability to manage multiple tasks simultaneously and complete work within allocated timeframes

Our Offer:

You will be joining an international and multi-cultural company that includes over 20 different nationalities with English as our working language.

Our employees are our strongest asset. With a low employee turnover rate, we offer job stability and growth opportunities through on-the-job training and mentoring programs. Working at IDDI will bring you an expertise that is widely recognized in our industry.

Our customers value our flexibility, responsiveness and proactive approach.

A unique opportunity to work in a friendly, team-oriented and stimulating environment. We regularly enjoy company-wide events such as BBQs, family-day outings, sports, and charity fundraisers, giving the chance to share time together.

We offer a competitive salary and benefits package including health, dental and vision insurance plans, short and long-term disability insurance, life insurance as well as flexibility for a better work-life balance (working hours, home-working opportunities, paid time off).

Interested in this challenging position?

Please send your CV and cover letter highlighting your motivation and relevant professional experience for the position by e-mail at careersUSA@iddi.com (to the attention of Ms. Marie-Pierre Debroas).