Senior Data Manager
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Måløv
Do you want to be a key player in the drug development process ensuring future submissions, and are you passionate about data management? Are you motivated by handling multiple stakeholders and several tasks at the same time? Then you may be the next member of our team. Take the next step in your life-changing career and join us in Non-clinical Data Management.
The position As a Senior Data Manager, you will be responsible for the non-clinical data flow through the systems we use for collecting data in-house and for the reception of data from contract research organisations (CROs) to our non-clinical data repository. You will work closely with internal as well as external partners and hence, having broad and daily contact with colleagues and partners within different non-clinical disciplines.
You will coordinate and implement timely set-up of data management systems and handle all non-clinical study related documentation.
Your areas of responsibility will be: Responsible for timely delivery of high-quality project deliverables and coordination of data management processes in designated non-clinical study and submission sections. Ensure all tasks performed are given priority, conducted, and reported according to customer needs. Provide project activity overview to line of business. Prepare and review reports and ensure that validation and study data activities are properly finalized and reported. Ensure compliance with current GxP (GLP and GCP) regulations, and the necessary innovative approaches are established for the team, to become a centre of excellence meeting regulatory requirements for handling study data. Continuously ensure that processes and programming used in the department always are state-of-the-art and that new approaches are implemented to meet current and future demands. Interact with members from external organizations, e.g. CDISC.
Qualifications
To thrive and succeed in this position we would expect you to have: A PhD, MSc or BSc in computer science, information technology or natural sciences. A minimum of 3 years of experience as Data Manager. Preferably experience in the pharmaceutical industry, including GxP knowledge. Experience with SAS and implementation of SEND (Standard for Exchange of Nonclinical Data), SDTM (Study Data Tabulation Model), or with running CDISC clinical studies is considered an advantage. Likewise, R and AWS infrastructure experience would be an advantage. On a personal level, you possess strong cooperation skills while being able to work independently. You are a strong coordinator, who is good at keeping an overview of several processes at once. You take on responsibility and show initiative to drive new successes. Furthermore, you are a strong communicator, who speaks and writes English fluently.
About the department
Digital Science & Innovation (DSI) is supporting the digital journey across all our therapy areas in R&ED. In DSI, we work in multidisciplinary teams – in strong collaboration with all areas across R&ED and DD&IT R&ED. We participate in drug development projects across the value chain, from early discovery to pre-clinical development. We engage in external collaborations to ensure access to the latest research and technology enablers, and we automate our labs and processes, and we focus on developing and retaining top talent.
Located in Måløv, Non-clinical Data Management is a part of Research Data Management in R&ED Digital Science & Innovation. Our main task is to handle data management activities in GLP or GCP regulated areas working with standardised data.
The implementation of SEND (Standard for Exchange of Nonclinical Data) requirements is anchored in our department where we have built a simple and effective SAS solution to meet the requirements and support the involved processes. Our department consists of ten data management colleagues and now we are looking forward to welcoming a new and ambitious colleague to our team.
Working at
At , we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care. Contact
For further information, please contact Pia Jellinggaard, Director Non-clinical Data Management, at Deadline
28 October 2024. Interviews will be held continuously, so please do not hesitate to submit your application at your earliest convenience. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment pro-cess, please refrain from adding a photo in your CV.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
The position As a Senior Data Manager, you will be responsible for the non-clinical data flow through the systems we use for collecting data in-house and for the reception of data from contract research organisations (CROs) to our non-clinical data repository. You will work closely with internal as well as external partners and hence, having broad and daily contact with colleagues and partners within different non-clinical disciplines.
You will coordinate and implement timely set-up of data management systems and handle all non-clinical study related documentation.
Your areas of responsibility will be:
Qualifications
To thrive and succeed in this position we would expect you to have:
About the department
Digital Science & Innovation (DSI) is supporting the digital journey across all our therapy areas in R&ED. In DSI, we work in multidisciplinary teams – in strong collaboration with all areas across R&ED and DD&IT R&ED. We participate in drug development projects across the value chain, from early discovery to pre-clinical development. We engage in external collaborations to ensure access to the latest research and technology enablers, and we automate our labs and processes, and we focus on developing and retaining top talent.
Located in Måløv, Non-clinical Data Management is a part of Research Data Management in R&ED Digital Science & Innovation. Our main task is to handle data management activities in GLP or GCP regulated areas working with standardised data.
The implementation of SEND (Standard for Exchange of Nonclinical Data) requirements is anchored in our department where we have built a simple and effective SAS solution to meet the requirements and support the involved processes. Our department consists of ten data management colleagues and now we are looking forward to welcoming a new and ambitious colleague to our team.
Working at
At , we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care. Contact
For further information, please contact Pia Jellinggaard, Director Non-clinical Data Management, at Deadline
28 October 2024. Interviews will be held continuously, so please do not hesitate to submit your application at your earliest convenience. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment pro-cess, please refrain from adding a photo in your CV.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
Information og data
Denne ledige stilling har jobtypen "Softwareudvikler", og befinder sig i kategorien "Informationsteknologi".
Arbejdsstedet er beliggende i Måløv.
Jobbet er oprettet på vores service den 14.10.2024, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
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