Inde 13.02.2020

Senior Clinical Database programmer in RAVE - Pune (India)

Tasks

Aixial India is recruiting a Senior Clinical Database programmer in RAVE :

 

  1. Provide leadership to the Clinical System’s department in the area of technical expertise.
  2. Plan and coordinate database design, development, implementation, maintenance, and user support of clinical systems.
  3. Program, test, and document databases in accordance with programming standards and validation procedures.
  4. Mentor other team members and Lead Programmers in training and developing technical and/or database expertise.
  5. Independently bring project solutions to the CDP teams and the Clinical Data Programming department.
  6. Collaborate with IT in evaluating and/or developing and implementing new technologies.
  7. If required, act as an internal subject matter expert in specific areas providing technical support and expert advice.
  8. To work independently to support various programming activities related to clinical systems.
  9. If required, the Senior Database Programmer can assist the Database Primary or Technical Lead role on projects, and liaise with sponsors, Data Management Lead and other functional areas.
  10. General areas of responsibility also includes: eCRF design, edit check programming and integration of third-party systems with the EDC databases.
  11. Need to abide by corporate quality standards, SOPs/Work Instructions/Guidelines, ICH-GCP and/or other international regulatory requirements.
  12. Develop, revise, and maintain core operating procedures and working instructions with CDP management.
  13. Meet milestones as assigned, and interact with the project team to organize timelines, responsibilities and deliverables.
  14. May interact with corporate team and CDM team members to negotiate timelines, responsibilities, and deliverables.

Requirements

Education, Experience and skills

  • Bachelor’s degree (or equivalent) work Experience and 8+ years clinical database programming experience or equivalent combination of education, training and experience
  • Project management knowledge 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
  • Excellent negotiation 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

 

Permanent contract  

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