Job Description:
The Genentech Global Data Standards Manager (GDSM) Intern Program is an intensive 12 month opportunity introducing Interns to the dynamic, exciting world of Clinical Data Standards. On 17 December 2014, the Food and Drug Administration (FDA) released a binding guidance for industry that mandates the use of Industry clinical data standards (e.g.: CDISC standards (Clinical Data Interchange Standards Consortium) for electronic submissions of clinical trial data. The mandate became effective on 17 December 2016, hence the increasing need for our company to support various functions in our organization with the adoption and implementation of these standards. As an intern, you will be joining the Data Standards Office (DSO) group, which is part of the Product Development Biometrics group. DSO is a small global group (<20 representatives) responsible for the design, management and maintenance of clinical trial data standards from protocol to submission aligned with the CDISC industry standards. The Data Standards Office plays a pivotal role in ensuring our Company complies with the new FDA requirement for electronic submissions. In addition to meeting regulatory requirements, our CDISC-aligned clinical data standards make it possible to collect data consistently across our clinical trial which accelerates data analysis, greatly facilitates the pooling of data across trials, and makes it easier to share data in a seamless and transparent way for both internal and external use. Bringing new drugs to market with the potential of making a significant improvement in patient’s lives is contingent on the outcome of controlled human clinical trials that statistically prove both the safety and efficacy of new drug candidates. It is also contingent on our ability to comply with new regulatory requirements. As a Global Data Standards Manager in the DSO, you will contribute to the design, management and maintenance of clinical trial data standards with a focus on electronic lab and biomarkers data standards. You will support cross-functional representatives in the Product Development organization with the adoption and implementation of the lab and biomarker standards in their clinical trials. You will also help maintain the standards in a metadata repository to ensure it continuously reflects latest approved data standards. You may serve as a Global Data Standards expert resource in lab/biomarker implementation projects/initiatives. Genentech GDSM Interns may be considered for full-time employment in the Data Standards Office as opportunities present. Target start date: Jun-201712 months full time internship. Who You Are: -Must be a recent graduate - Master’s degree, preferably in Biochemistry and/or Bioinformatics. -Candidates must have a strong knowledge of laboratory and biomarkers data. -Excellent verbal and written communication skills. -Demonstrated leadership skills and experience. -Good organizational skills. -High attention to detail.
Additional Info:
NOTE: As part of the application process candidates are requested to submit a 350-500 word cover letter on why they should be selected for the program and what they hope to learn as a result of their participation. Who We Are: A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work. The next step is yours. To apply today, click on the "Apply online" button below. Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.[Click Here to Access the Original Job Post]
The Genentech Global Data Standards Manager (GDSM) Intern Program is an intensive 12 month opportunity introducing Interns to the dynamic, exciting world of Clinical Data Standards. On 17 December 2014, the Food and Drug Administration (FDA) released a binding guidance for industry that mandates the use of Industry clinical data standards (e.g.: CDISC standards (Clinical Data Interchange Standards Consortium) for electronic submissions of clinical trial data. The mandate became effective on 17 December 2016, hence the increasing need for our company to support various functions in our organization with the adoption and implementation of these standards. As an intern, you will be joining the Data Standards Office (DSO) group, which is part of the Product Development Biometrics group. DSO is a small global group (<20 representatives) responsible for the design, management and maintenance of clinical trial data standards from protocol to submission aligned with the CDISC industry standards. The Data Standards Office plays a pivotal role in ensuring our Company complies with the new FDA requirement for electronic submissions. In addition to meeting regulatory requirements, our CDISC-aligned clinical data standards make it possible to collect data consistently across our clinical trial which accelerates data analysis, greatly facilitates the pooling of data across trials, and makes it easier to share data in a seamless and transparent way for both internal and external use. Bringing new drugs to market with the potential of making a significant improvement in patient’s lives is contingent on the outcome of controlled human clinical trials that statistically prove both the safety and efficacy of new drug candidates. It is also contingent on our ability to comply with new regulatory requirements. As a Global Data Standards Manager in the DSO, you will contribute to the design, management and maintenance of clinical trial data standards with a focus on electronic lab and biomarkers data standards. You will support cross-functional representatives in the Product Development organization with the adoption and implementation of the lab and biomarker standards in their clinical trials. You will also help maintain the standards in a metadata repository to ensure it continuously reflects latest approved data standards. You may serve as a Global Data Standards expert resource in lab/biomarker implementation projects/initiatives. Genentech GDSM Interns may be considered for full-time employment in the Data Standards Office as opportunities present. Target start date: Jun-201712 months full time internship. Who You Are: -Must be a recent graduate - Master’s degree, preferably in Biochemistry and/or Bioinformatics. -Candidates must have a strong knowledge of laboratory and biomarkers data. -Excellent verbal and written communication skills. -Demonstrated leadership skills and experience. -Good organizational skills. -High attention to detail.
Requeriments :
Skills :
Additional Info:
NOTE: As part of the application process candidates are requested to submit a 350-500 word cover letter on why they should be selected for the program and what they hope to learn as a result of their participation. Who We Are: A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work. The next step is yours. To apply today, click on the "Apply online" button below. Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.[Click Here to Access the Original Job Post]