Leader of SDTM (Study Data Tabulation Model) Standards
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Do you have a strong background in clinical trial conduct and data standards development within the pharmaceutical industry? Are you passionate about leading teams, developing experts and about data? Do you know how to broaden awareness of your department’s responsibilities and have a gut feeling on when to promote the achievements and cool releases? If yes, we want you to lead our SDTM Standards department! Apply today for a life-changing career. The position As a Leader for the SDTM (Study Data Tabulation Model) Standards department, you will have the following key responsibilities: Ensure continued development of Clinical Data Standards in collaboration with Clinical Data Operations & Insights (CDOI), Biostatistics, Trial Management, Medical & Science, Clinical Pharmacology and Global Safety Functionally responsible for the programming framework utilised to transform all clinical data into the SDTM data model, Define-XML and Study Data Reviewers Guides on all clinical trials and submissions in Global responsibility enabling the SDTM Programming departments in delivering data in the SDTM data model on all Clinical Trials and submissions in collaboration with the Standard Developer departments In collaboration with the leadership team: Enforce global Clinical Data Standards in line with global regulatory requirements Compliance with global data standard requirements is a prerequisite for to submit new drug applications and supplementary applications such as clinical label updates and label expansions Securing retrospective ad hoc solutions for clinical trials and submissions and legacy data Lead the Data Standards & Outreach (DSO) team of 13 people in accordance with the Way including developing the employees to meet the current and future DaMaSyS and ’s business needs Manage the DSO team and ensure that budgets and business targets are met Contribute to cross-functional and cross-project standardisation and process optimisation Represent DSO, Data Management Systems & Standards (DaMaSyS), CDOI, Data Science (DS), Development internally and externally The job is based in Søborg Denmark, however, travelling to Bengaluru and Functional Suppliers 1-2 times per year may be a part of the job. Qualifications To be successful in this role, we are looking for candidates with the following qualifications: University degree in natural sciences or computer sciences Minimum 5 years of experience with clinical trial conduct and/or clinical data standards governance, hereof 3 years within the pharmaceutical industry. Preferably with a minimum 2 years of leadership experience. Profound knowledge of drug development and basic medical terminology. In-depth knowledge of computer systems, and programming/software development. Knowledge of the data structures in CDISC controlled data models (SDTM, ADaM), concepts of metadata, automation and/or data warehouse systems. Experience with development of clinical standards and knowledge of external standards (e.g. CDISC) Experience with collaboration across professional and regional borders. Regular experience with communication and presentations. In-depth knowledge of GxP and guidelines within drug development. Experience working under quality requirements such as GCP and ISO. About the department In Development, we are responsible for managing clinical drug development worldwide, ensuring that the process lives up to uniform global standards, regulations and business ethics while delivering viable products that make a difference to patients and ultimately benefit society. The department, Data Standards and Outreach, is a part of Data Science and consists of 13 enthusiastic and highly engaged people with both broad and specialist knowledge. The composition of industry acknowledged Subject Matter Experts and innovative mindsets provides optimal training grounds for anyone with a desire to boost their pharma industry knowledge to the highest level. The main responsibility is to enable the delivery of world class quality SDTM data on all clinical trials, keeping our submissions in compliance with regulatory requirements. We do this partly by controlling and developing SDTM Standards and via development and development/maintenance of an automated SDTM Standard programming framework, and partly by keeping our fingers on the pulse of the regulatory agencies’ submission requirements as well as on the direction of the pharma industry. 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 Should you wish to learn more about this unique position, please feel welcome to contact Martin Lindhard, Director, Data Standards & Outreach at Deadline April 7th, 2024 Please note, we will invite candidates for interviews on an ongoing basis and conclude the recruitment process when the right candidate has been found. We kindly suggest that you do not attach a photo of yourself to your application or resume, as it helps us be fairer in our selection process. 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 Søborg.
Jobbet er oprettet på vores service den 4.3.2024, 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.
- Softwareudvikler
- Søborg
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