Clinical Technical Data Analyst
XDIN subsidiary of ALTEN Group, includes 500 employees dedicated to the automotive engineering development. ALTEN is a Leader in Engineering & Information Technology system, and operates in over 21 countries (Europe, North America, Asia, Africa and Middle East) with more than 28,000 employees of which 88% are engineers.
At XDIN, we are always looking for world-class talent to lead our global teams through commitment and dedication to our OEM and Tier I clients. We believe in quality support from concept through production, and delivering the best customer experience while at the same time attaining a great place to work!
- Competitive wages, BOE.
- Major health, dental insurance benefits and vision savings plan. 401k, and basic life.
- Supplemental benefits such as short-term disability, accident, cancer and life insurance.
- Paid company holidays and earned time off.
We place a high value on thought leadership. We want every employee to develop all the skills required to become an engineering and technology thought leader; contributing to the knowledge assets of our team and our clients. From day one, every consultant is trained and mentored to elevate their careers.
- Server and Desktop Programming Tools (Shell, R & Python)
- Bachelor’s degree and demonstrated experience or 10 years of demonstrated experience in similar role
- Effective written and oral communications skills
- Strong teamwork, interpersonal and influencing skills, as well as networking capabilities within IT organization
- Technical validation of Information Systems in line with GXP, 21 CFR part 11 and other applicable regulations in collaboration with IT Risk & Compliance and Quality & Risk Management.
- Ensure availability of the Laboratory System(s) for productive use as per defined support model.
- Ability to write the technical documentation supporting Information Systems end-users (e.g. User guide).
- Pharmaceutical drug/vaccine development experience
- Have an excellent knowledge of Validation processes (IQ/OQ/PQ), current regulatory requirements related to ISO13485/FDA CFR and ALCOA+ standards.
- Developing, implementing and using operational metrics
- Achieve data integrity and point out where data integrity might be at risk.
- Proven experience using Database solutions (Access/SQL/Oracle)
- Strong skills in Microsoft Operating systems and PC hardware and software configurations
- Work experience in a regulated environment
- Some experience working in a complex global organization
- Bachelor in Bioinformatics, Life Sciences, Computer Sciences, Engineering, Mathematics or Physics
- 3 to 5 years of proven experience in computer validation or in a clinical environment, ideally both
- English is a must.