Date: 10 Aug 2024Location: SFEL - R&D; SANT FELIU DE LLOBR, ES, ES - SpainCompany: AlmirallMission: Based on best international practices, capture, integrate and store clinical trials information (data and documents) to allow ongoing data analysis and results reporting to access efficiently to clinical data of our medicinal products and to allow a shorter decision-making process.Tasks and Responsibilities Responsible for performing the necessary internal processes and overseeing CRO activities for adherence to the applicable data standards, quality, and timelines, following Good Clinical Data Management Practices and applicable Clinical Trials Regulations, like FDA, EMA, ICH.Review the protocol for adherence to Almirall Data Management processes and Data Standards.Lead the review and approval of electronic Case Report Form (eCRF), electronic Patient Reporting Outcomes (ePRO), and its corresponding completion guidelines.Management of any data findings or processes during trial conduction that implies changes in the standards/processes in alignment with the responsible lead of coordinating these standards.Set-up: Review annotated documents, Data Management Plan (coding, validation plan, SAE reconciliation between safety and clinical databases), vendor's technical specifications (from DM perspective).Conduct: Manage with the CRO to have data available for data visualization and analysis at the agreed milestones established at contract level. Assessment of the database structure and study documentation review, evaluation of the data quality on an ongoing basis.Coordination of Almirall data review activities and follow-up or finding resolution with CRO.Closure: Management of the database lock processes, review related database lock documentation (including approval of coding and SAE reconciliation), evaluation of the database quality (minimum requirements) before database lock approval to warrant Almirall requirements.Provision to CROs of the necessary documentation to perform the outsourced activities according to Almirall standards processes and expectations.Follow-up on target and metrics indicators for overseeing quality and deliverables of CRO Data Management activities.Participation together with the Q&A department in the inspections derived from the clinical trial.Provide technical advice on Data Management methodologies and processes to other departments or areas of R&D and the company who requires it.Analysis and assessment of new standards, systems, and processes. Collaboration in the implementation and development of new technologies.Meeting with external assessors & regulatory authorities when required.Participation in Data Management Associations, trainings, and Congresses, national and international, related to Data Management and Clinical Development methodology and techniques, with the objective of warranting the continuous training and regular update of the required knowledge.#J-18808-Ljbffr
