Are you …
...looking for an entrepreneurial fast-growing company specialised in supporting interventional clinical trials where taking ownership and collaboration are key values?
…ambitious and aspiring to play a crucial role in bringing new medical treatments to market?
Then check out this great opportunity to join us as a Clinical Database Developer
Who are we
DICE is a clinical research organization (CRO), that carries out all biometrics aspects of clinical research for pharmaceutical and biotechnology companies, from data management to processing statistical analysis and clinical study report compilation. DICE provides (electronic) data capture, data management, statistics, PK analysis, central imaging reviews, medical monitoring and medical writing services. Check us out on: www.dice-cro.com.
What makes DICE unique
- We offer an entrepreneurial environment where you get to partner with start-ups as well as well-established companies. You will be instrumental in their success to bring new medicines to market safeguarding the correct processes based on regulatory guidelines and internal DICE QMS
- You will be working on a variety of projects and contribute to different aspects ranging from defining a CDISC SDTM structure for a clinical development program to the implementation of clinical database updates following protocol amendments. You will be in the driving seat and have an impact on the projects on which you are working.
- We are committed to your continuous learning and development.
- Collaboration and team spirit define our culture and strong values like service, excellence, integrity and ownership – ensure we deliver superior results for our customers
What will you be doing
- You will be responsible for the set-up of clinical databases as part of a clinical study and/or clinical development program.
- Translate clinical study protocols into CRF screen documents, database annotations and automatic edit checks to be performed upon data entry.
- Ensure consistency of the database specifications with CDISC-CDASH and CDISC-SDTM where applicable.
- Develop and oversee release strategy: development of test plan, execution of test plan, resolution of issues and database deployment.
- Create documentation and training to correctly enter the data in the database application: E-CRF completion guidelines, E-CRF training for investigator and site training.
- Develop and oversee access management: definition of roles, training needs and documentation of training, database access and removal from database access.
- Update the clinical database, as well as supporting documents based on global or local protocol amendments.
- Liaise with internal departments, sponsors and other third parties to ensure all delivery requirements fulfil client needs.
- Lead internal projects in view of driving system and process improvements, and develop and implement solutions to improve the efficiency and quality of clinical study data processing and reporting:
- Implementation of CDISC standards on the level of database development
- Standardization of procedures (CRF development, programming)
- Validate software, in the role of system tester, and test SAS Macros, maintaining the required validation and testing documentation.
- Develop regulatory standards knowledge in computer systems, systems validation, Good Clinical Practice, clinical data management, clinical reporting and regulatory submission requirements.
- Assist with Quality Assurance and Audit requirements.
- Ensure the maintenance of documentation e.g. the description of programs and validation.
Ideal work experience and education
- Graduate degree in informatics, computer science or a Master Degree in a numerate field like Mathematics, Physics, (Bio-/Commercial-) Engineer or similar through experience.
- At least 5 years of experience in clinical trials.
- 2-5 years’ experience in database development according to CDISC standards CDASH, SDTM and ADaM.
- Knowledge of ICH and other guidelines in clinical research.
- Knowledge of E-CRF systems like Medidata rave, Oracle inform, Viedoc, etc is considered as a plus.
- Excellent verbal and written communication skills in English and Dutch or French.
- You have proven to be capable of analytical thinking, either through education or experience.
What makes you stand out
- Focus with an eye for detail
- Achievement orientation and high energy
- Entrepreneurial mindset with a customer obsession
- Can do attitude and the flexibility to engage in a variety of tasks
- Growth mindset to continuously learn and stay on top of latest developments
- The ability to work autonomously, as well as collaboratively in a team, in an atmosphere where giving constructive feedback is a must
What we offer
- A competitive package with extra-legal benefits (company car, mobile phone, meal vouchers, and insurances package)
- A young and dynamic work environment
- A strong commitment to your professional growth and continuous development
- An easy to reach office & possibilities to work from home
Your success will be the result of your entrepreneurial drive, passion for delivering superior results and your desire to fulfil the commitments to clients and co-workers.
Take your career to the next level, and apply now!