Senior 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, providing agile clinical trials services for pharmaceutical, biotechnology, and medical device/diagnostic companies. 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 and commitment to quality and innovation, we are actively looking for a passionate, proactive, and scientifically-driven individual to reinforce our team in the US (Raleigh, NC) for an important role as a:

Senior Lead Clinical Data Manager

Your role:

As Senior Lead Clinical Data Manager (CDM), you will be responsible for the end-to-end data management process for complex medical research projects in a diverse range of therapeutic areas.

You will play a key role in managing, coordinating, and performing all data management activities for responsible projects. You will ensure on-time delivery of high quality and accurate data to facilitate statistical analysis. You will also ensure data are kept secure throughout the full process of data collection.  

You will work very closely with the Biostatistical Services team, and will be the CDM primary contact for all other IDDI stakeholders, as well as the study Sponsor in this critical client facing role.

By participating in the regular review of CDM processes, you will play an active role in the continuous improvement of our operational excellence, both in the CDM team and at IDDI in general.

Based on your expertise, you will coach and train your peers to improve the quality and efficiency of our data management services.

Your responsibilities: 

  • Manage and coordinate all activities related to Data Management during the clinical trial to ensure the project’s schedule is respected. This involves regular contact with all CDM team members (i.e., EDC specialists, Programming specialists, Data cleaning and coding specialists)
  • Produce and maintain key study related CDM documentation
  • Ensure the CRF (Case Report Form) 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 study Sponsor
  • Ensure external data (e.g., labs, serious adverse events) are transferred and reconciled with the clinical database
  • Perform database unblinding and lock activities in close collaboration with the Sponsor, Project Manager, Biostatistician, and other parties
  • Develop Data Management standards (templates and processes)
  • Communicate proactively with the sponsor and other project collaborators about data management activities status and potential issues.

Your profile: 

The successful candidate must have a Master’s degree in the life sciences or a health-related field and at least 5 years of experience in a similar position. In addition, the position requires:

  • Knowledge of EDC systems such as RAVE (Medidata) or MARVIN (EvidentIQ)
  • Demonstrated working experience in SAS programming and CDISC standards
  • Excellent knowledge of English, both oral and written
  • Good planning and analytical skills
  • Excellent communication skills
  • Ability to work in a fast-paced and regulated research environment

Our Offer:

You will join an international and multi-cultural company that includes over 20 different nationalities (English is the working language) and where employees are the strongest asset.

At IDDI, 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 (flexible 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