Clinical Database Programmer-Pune, India
AIXIAL is an International Contract Research Organization (CRO), a member of the ALTEN Group, providing complex services in clinical trials (phase I-IV) and non-interventional studies. Our offices are located in France, Belgium, Germany, Czech Republic and India.
Due to fast growth of our company we are currently recruiting a colleague for the position of an Clinical Database programmer, the position would be based in Pune.
Clinical database setup.
1. Plan and coordinate database design, development, implementation, maintenance, and user support of clinical systems.
2. Program, test, and document databases in accordance with programming standards and validation procedures.
3. Mentor other team members in training and developing technical and/or database expertise.
4. Independently bring project solutions to the CDP teams and the Clinical Data Programming department.
5. Collaborate with IT in evaluating and/or developing and implementing new technologies.
6. If required, act as an internal subject matter expert in specific areas providing technical support and expert advice.
7. To work independently to support various programming activities related to clinical systems.
8. Assist the Database Primary or Technical Lead role on projects, and liaise with sponsors, Data Management Lead and other functional areas.
9. General areas of responsibility also includes eCRF design, edit check programming and integration of third-party systems with the EDC databases.
10. Need to abide by corporate quality standards, SOPs/Work Instructions/Guidelines, ICH-GCP and/or other international regulatory requirements.
11. Develop, revise, and maintain core operating procedures and working instructions with CDP management.
12. Meet milestones as assigned, and interact with the project team to organize timelines, responsibilities and deliverables.
13. May interact with corporate team and CDM team members to negotiate timelines, responsibilities, and deliverables.
Education, Experience and skills
· Bachelor’s degree (or equivalent) work Experience and 2-5 years clinical database programming experience or equivalent combination of education, training and experience
· Attention to detail and quality of documentation
· Good interpersonal skills
· Effective oral and written communication skills
· Excellent decision making, organizational and planning skills
· Ability to work independently
· Work effectively in a quality-focused environment. Experience in at least one programming environment (e.g. SAS, CDMS, EDC, SQL, VB, Java).
· Analytical and investigative skills
· Knowledge of SOPs/Guidelines/Work Instructions/System Life Cycle methodologies, ICHGCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application.
· Ability to act as liaison with other project members, and in particular with the Lead Clinical Data Managers
Technical knowledge :
· Microsoft OfficePostuler