Principal Standards Specialist
- Research & Development
- Denmark - Søborg
Are you an expert in clinical standards and data management? We are looking for a Principal Specialist to join our team of Standards Supporters who are supporting standardised trial set-up across Data Management systems in Novo Nordisk. We are part of the Global Development organisation responsible for transforming promising new drug candidates into effective treatments for patients.
About the Department
Data Management Standards & Support is situated in Søborg and currently employs 22 people working in various roles to support standard ways of handling data across Novo Nordisk clinical trials. You will be part of a team that supports the use and governance of our clinical data standards across multiple systems used for data collection and reporting of our clinical trials. We work closely with multi-functional and international teams on a variety of clinical and technical projects in a pleasant and informal atmosphere.
The job
The Principal Standards Specialist is an expert in supporting clinical trial teams during the set-up phase of their trials, and acts as a mentor for Standards Supporters in technical problem-solving as well as process support The Principal Standards Specialist is a role model in stakeholder management and is able to communicate effectively with diverse and sometimes challenging stakeholders, which includes Data Managers, Biostatisticians, Statistical Programmers, Trial Managers and others within clinical development.
The Principal Standards Specialist’s primary focus will be to provide technical expertise in Novo Nordisk’s Data Management systems (with focus on Oracle Clinical) and especially the handling of lab data. The Principal Standard Specialist will participate in improvement projects related to standards, including a newly established initiative to implement CDISC controlled terminology. The Principal Standards Specialist will also suggest process improvements, give input to the prioritisation of improvements, and lead teams of cross-functional colleagues to implement improvements, both large and small.
The Principal Standards Specialist will actively share best practices across the organisation and provide training in areas of expertise, as well as maintain system related documentation and provide business support.
Qualifications
You have in-depth experience working with standards in clinical IT systems, especially EDC (Oracle Inform), CDMS (Oracle Clinical), and Clinical Data Warehouse solutions. You have deep knowledge of relational databases and standards governance and extensive experience working with laboratory or genetic data in clinical trials. You have a proven ability to understand and communicate with stakeholders in Data Management, Biostatistics, and Trial Management, including the ability to provide targeted training in our systems and processes. Knowledge of CRF design, SAS programming, and CDISC is also beneficial. You show initiative, work independently, seek guidance when needed, and take responsibility for delivering high-quality results on time and on budget.
Furthermore, you are comfortable working in English on a daily basis (both spoken and written) in a global organisation. You have very strong cooperative and analytical skills, excellent coordination skills, and excel when performing detailed work. We expect you to be able to maintain an overview of several tasks in parallel without compromising the quality of your work and that you remain high spirited, also when things are moving fast.
In return we offer an interesting and challenging job with a high degree of individual responsibility and good personal development opportunities in an international atmosphere.
In Novo Nordisk is your skills, your commitment and your ambitions, which helps us to improve many people's lives. In return we offer you the opportunity to work with exceptionally talented colleagues, and we offer you a wide range of opportunities for professional and personal development.
Contact
For further information, please contact Dorte Straarup +45 3079 5986 or Heather Brage +45 3075 0076.
Deadline
21 August 2013.
- Research & Development
- Denmark - Søborg
Are you an expert in clinical standards and data management? We are looking for a Principal Specialist to join our team of Standards Supporters who are supporting standardised trial set-up across Data Management systems in Novo Nordisk. We are part of the Global Development organisation responsible for transforming promising new drug candidates into effective treatments for patients.
About the Department
Data Management Standards & Support is situated in Søborg and currently employs 22 people working in various roles to support standard ways of handling data across Novo Nordisk clinical trials. You will be part of a team that supports the use and governance of our clinical data standards across multiple systems used for data collection and reporting of our clinical trials. We work closely with multi-functional and international teams on a variety of clinical and technical projects in a pleasant and informal atmosphere.
The job
The Principal Standards Specialist is an expert in supporting clinical trial teams during the set-up phase of their trials, and acts as a mentor for Standards Supporters in technical problem-solving as well as process support The Principal Standards Specialist is a role model in stakeholder management and is able to communicate effectively with diverse and sometimes challenging stakeholders, which includes Data Managers, Biostatisticians, Statistical Programmers, Trial Managers and others within clinical development.
The Principal Standards Specialist’s primary focus will be to provide technical expertise in Novo Nordisk’s Data Management systems (with focus on Oracle Clinical) and especially the handling of lab data. The Principal Standard Specialist will participate in improvement projects related to standards, including a newly established initiative to implement CDISC controlled terminology. The Principal Standards Specialist will also suggest process improvements, give input to the prioritisation of improvements, and lead teams of cross-functional colleagues to implement improvements, both large and small.
The Principal Standards Specialist will actively share best practices across the organisation and provide training in areas of expertise, as well as maintain system related documentation and provide business support.
Qualifications
You have in-depth experience working with standards in clinical IT systems, especially EDC (Oracle Inform), CDMS (Oracle Clinical), and Clinical Data Warehouse solutions. You have deep knowledge of relational databases and standards governance and extensive experience working with laboratory or genetic data in clinical trials. You have a proven ability to understand and communicate with stakeholders in Data Management, Biostatistics, and Trial Management, including the ability to provide targeted training in our systems and processes. Knowledge of CRF design, SAS programming, and CDISC is also beneficial. You show initiative, work independently, seek guidance when needed, and take responsibility for delivering high-quality results on time and on budget.
Furthermore, you are comfortable working in English on a daily basis (both spoken and written) in a global organisation. You have very strong cooperative and analytical skills, excellent coordination skills, and excel when performing detailed work. We expect you to be able to maintain an overview of several tasks in parallel without compromising the quality of your work and that you remain high spirited, also when things are moving fast.
In return we offer an interesting and challenging job with a high degree of individual responsibility and good personal development opportunities in an international atmosphere.
In Novo Nordisk is your skills, your commitment and your ambitions, which helps us to improve many people's lives. In return we offer you the opportunity to work with exceptionally talented colleagues, and we offer you a wide range of opportunities for professional and personal development.
Contact
For further information, please contact Dorte Straarup +45 3079 5986 or Heather Brage +45 3075 0076.
Deadline
21 August 2013.