The International Drug Development Institute (IDDI) is a therapy-focused expert regulatory statistics, clinical data services and high-level strategic consulting contract research organization committed to increasing efficiency and mitigating risks throughout the drug development process. For over 30 years, we have provided agile clinical trial services for pharmaceutical, biotechnology, and medical device/diagnostic companies to ensure their clinical data is ready for submission.
With a deep expertise in advanced biostatistics and study design, they also offer regulatory, statistical and clinical consultancy, comprehensive data management services and integrated RTSM-EDC for the successful execution of clinical development program even with complex settings.
IDDI is currently looking for a Senior System Validation Specialist (based in Ottignies office / Hybrid) to strengthen our team.
Your responsibilities:
- Define validation strategies for internal and external systems;
- Harmonize and streamline validation practices;
- Take ownership of the Computer System Validation process and act as Subject Matter Expert for Computer System Validation;
- Author validation documents (URS, validation plan, test plan, validation report and etc.) and system documentation;
- Provide input to the Project team for the planning of study-specific eClinical system validation related tasks;
- Work closely with QA to ensure that the Computer System Validation regulations are applied;
- Ensure readiness for audits and inspections;
- Support QA during audits and inspections;
- Training and coaching of junior System Validation Specialists;
- Perform testing and validation of core IDDI internal systems following new development and of external systems according to software supplier’s release schedule Write/Update user manuals.
Requirements:
- University degree in life science or computer science
- Extensive experience (at least 5 years) in computer system validation related to Clinical Trials;
- Familiar with US & EU regulations regarding Computer System Validation.
- Knowledge of 21 CFR Part 11, GAMP 5 and the EMA Guideline on computerized systems and electronic data in clinical trials;
- Good attention to details;
- Works well under pressure;
- Excellent communication, organizational, planning and interpersonal skills;
- Must be able to operate independently with minimal supervision;
- Fluency in English, both written and oral
Our offers:
- A unique opportunity to work in an international, friendly, team-oriented, and stimulating environment.
- An expertise widely recognized in the industry.
- A competitive salary and benefit package as well as flexibility for a better work-life balance.
How to apply:
If you are interested in this opportunity, please address your application on our Recruitment portal.Only selected candidates will be contacted.