Contact Person : Latha
Contact No: 09980907023
Brief Description about the Job
- Multi-discipline role, with focus on delivering:
- Project leadership of assigned projects and/or
- Line management of assigned personnel and/or
- Technical expertise and leadership in support of project deliveries and training development of department personnel.
- Comprehensive knowledge of clinical and pharmaceutical drug development and associated ICH/GCP guidelines.
- Excellent knowledge of pharmaceutical industry standards
- Provide mentoring, as required.
- Ability to lead teams, as required.
- Ability to work with different functions and across sites as required.
- Ability to review and provide comments on clinical documents, e.g. protocol, CRF and SAP, perform Peer Review and Final Inspection.
- Ability to represent the company at external conferences and forums, from a clinical programming perspective
- Participate in meetings such as recruitment, business development and audits from a clinical programming perspective.
- Follow appropriate Project Management procedures.
- Ability to work independently as a programmer and advise on preferred programming solutions, develop and deliver SAS training and workshops and other programming related training sessions.
- Ability to plan resource requirements and project timelines, and recognise project training needs.
- Pro-actively address changing timelines, priorities and resourcing requirements in line with appropriate issue escalation processes.
- Responsible for the line management of up to 4 programmers.
- Perform an active role in the development of direct reports and/or provide training, mentorship and support for programmers as necessary.
Position Specific Experience
- At least 5-7 years programming experience, preferably within the pharmaceutical industry or medical sector.
- Knowledge and experience on pharmaceutical industry and requirements for delivery of clinical trials.
- Advanced Programming experience covering activities from study set-up to final reporting.
Position Success Factors
- Should have PC skills, excellent knowledge of statistical software packages (particularly SAS), excellent organisational skills, excellent English communication skills (oral and written), and excellent analytical skills.
- Has a proven ability to lead and work with teams.
- Has continuous improvement mentality and an excellent attention to detail.
Brief Description about the Job
Multi-discipline role, with focus on delivering:
- Project leadership of assigned projects and/or
- Line management of assigned personnel and/or
- Technical expertise and leadership in support of project deliveries and training development of department personnel.
- Comprehensive knowledge of clinical and pharmaceutical drug development and associated ICH/GCP guidelines.
- Excellent knowledge of pharmaceutical industry standards
- Provide mentoring, as required.
- Ability to lead teams, as required.
- Ability to work with different functions and across sites as required.
- Ability to review and provide comments on clinical documents, e.g. protocol, CRF and SAP, perform Peer Review and Final Inspection.
- Ability to represent the company at external conferences and forums, from a clinical programming perspective
- Participate in meetings such as recruitment, business development and audits from a clinical programming perspective.
- Follow appropriate Project Management procedures.
- Ability to work independently as a programmer and advise on preferred programming solutions, develop and deliver SAS training and workshops and other programming related training sessions.
- Ability to plan resource requirements and project timelines, and recognise project training needs.
- Pro-actively address changing timelines, priorities and resourcing requirements in line with appropriate issue escalation processes.
- Responsible for the line management of up to 4 programmers.
- Perform an active role in the development of direct reports and/or provide training, mentorship and support for programmers as necessary.
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