.Location: Barcelona, SpainJob reference: R-209726Date posted: 09/26/2024This is what you will do:As Senior Clinical Data Lead you are responsible for independently ensuring the accuracy and timely delivery of clinical data for both study and non-study projects. You will also contribute to the development of new concepts, technologies, and standards. Your role involves performing various tasks to guarantee the accuracy, completeness, and compliance of data crucial for publications and regulatory submissions.You will be responsible for:Collaborating with peers across the data management function to identify, design, and deliver appropriate data management solutions.Completing data management tasks and providing technical expertise while overseeing project deliverables from Contract Research Organizations (CROs), Functional Service Providers (FSPs), and vendors promptly.Innovating data collection methods and ensuring the development and delivery of medicines for our patients using strategic thinking, strong collaboration and communication skills, and an entrepreneurial mindset.Participating in or leading study-specific study start-up tasks, including case report form (CRF) design, edit check creation, CRF completion guideline (CCG) creation, user acceptance testing, and the development and maintenance of the Data Management Plan and Data Quality Review Plan.Participating in or leading data validation tasks for various studies during maintenance and close-out, focusing on data integrity and quality metrics.Participating in or leading ongoing operational support for all activities during clinical trial conduct, including database migrations, ad-hoc report creation, maintenance of external data transfer documents, import/export agreements and data specifications, and support for database lock and archiving activities.Ensuring that medical coding is completed for all data cuts and reviewed and approved by medical monitors.Ensuring that user administration in data management-owned systems and Trial Master File document filing are accurate and timely.You will need to have:A bachelor's degree in a scientific discipline or equivalent.Relevant experience in clinical data management for 3 or 4+ years; or equivalent experience at a hospital or research site with knowledge of medical terminology and experience defining, entering, processing, reviewing, and validating clinical data.Knowledge of the clinical data management and clinical development process, including the regulatory submissions for various agencies (FDA, EU, etc.) and knowledge of CDASH, application of FAIR (Findable, Accessible, Interoperable, Reusable) principles, MedDRA/WHO-DD dictionary coding and versioning, with exposure to digital technology, and data visualization technology.Effective written and verbal communication skills to interact professionally with personnel at all levels within and outside of the company
