Senior Clinical Database programmer - Pune (India)
Aixial India is recruiting a Senior Clinical Database programmer :
- Provide leadership to the Clinical System’s department in the area of technical expertise.
- Plan and coordinate database design, development, implementation, maintenance, and user support of clinical systems.
- Program, test, and document databases in accordance with programming standards and validation procedures.
- Mentor other team members and Lead Programmers in training and developing technical and/or database expertise.
- Independently bring project solutions to the CDP teams and the Clinical Data Programming department.
- Collaborate with IT in evaluating and/or developing and implementing new technologies.
- If required, act as an internal subject matter expert in specific areas providing technical support and expert advice.
- To work independently to support various programming activities related to clinical systems.
- 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.
- General areas of responsibility also includes: eCRF design, edit check programming and integration of third-party systems with the EDC databases.
- Need to abide by corporate quality standards, SOPs/Work Instructions/Guidelines, ICH-GCP and/or other international regulatory requirements.
- Develop, revise, and maintain core operating procedures and working instructions with CDP management.
- Meet milestones as assigned, and interact with the project team to organize timelines, responsibilities and deliverables.
- 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 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