Experienced Lead Clinical Data Manager

IDDI (International Drug Development Institute), founded in 1991, is a highly recognized biostatistical and eClinical service provider in the field of clinical research. To support our growth, we are actively looking for a:

Experienced Lead Clinical Data Manager.

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. Our customers value our flexibility, responsiveness and proactive approach.

By joining a group of 10 highly skilled Lead Clinical Data Managers, in the Clinical Data Management team of over 40 people, the successful candidate will strengthen the experienced group in Raleigh, NC – US (office based position).

Your role:

As Experienced Lead CDM you will ensure that all output for the studies, such as the SAS database, are delivered on time with the highest quality.

Your responsibilities will be to:

  • Coordinate the activities of the other CDM teams (EDC Specialists, Programming Specialists, Cleaning specialists…) to ensure the project’s schedule is respected.
  • Produce and maintain key study related Clinical Data Management documentation.
  • Ensure the CRF meets the data collection requirements of the study through a review of the protocol and other supporting documentation.
  • Define and review edit-checks included in the Data Validation Plan in agreement with the sponsor.
  • Ensure external data (Labs, SAEs, etc…) are transferred and reconciled with the clinical database.
  • Perform database unblinding and lock activities in close collaboration with the sponsor, Project Manager, statistician and other parties.
  • Develop Data Management standards (templates and processes).
  • Communicate with the sponsor and other project collaborators about data management issues.

Your profile:

The successful candidate must have a university degree in science, biostatistics or a health-related field and at least 5 years of experience in a similar position. In addition, the position requires:

  • Knowledge and experience in SAS programming and CDISC standards.
  • Excellent knowledge of English, both oral and
  • Good planning and analytical skills.
  • Excellent communication skills.
  • Ability to work under stress.

Our offer:

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. 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. 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.signalsuite.com (to the attention of Ms. Marie-Pierre Debroas).