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Insud Pharma

Junior Data Manager

hace 23 días

Madrid

In few wordss 📌 Position: Junior Data Manager Location: Madrid (onsite) Experience: 2-3 years of experience in data management. Extensive experience in clinical trial project data management and coordination. 👇Global Responsibility The Junior Data Manager will support the execution and monitoring of operational activities related to data management in clinical trials, working under direct supervision. They will collaborate with the study team to ensure quality and compliance of data management processes, contributing to the successful conduct of clinical projects. Specific Responsibilities • Assist all data management aspects of a clinical study with minimal oversight, including study start-up activities, and guide the study team through change orders and protocol amendments, • Assist in the development of DM documents including, but not limited to, Data Management Plans, CRFs, CRF Completion Guidelines, Edit Checks, UAT specifications, centralized monitoring plans, data flow and integrity plans, blinding plans, and data review plans. Utilize templates and standard guidelines to initiate documents, but exercise critical thinking and discretion to tailor documents to study needs, • Support to data cleaning activites such as, but not limited to, study team data reviews, Non-system Edit Check Output review, SAE reconciliation and non-CRF data reconciliation. Gather cross-functional input to create custom data review plans. Evaluate options and exercise discretion to choose efficient and effective issues resolution paths, • Demonstrate collaboration and relationship-building with all study team representatives (e.g. Biostatisticians, Statistical Programmers, Medical Monitors, Clinical Project Managers, Clinical Trial Managers, CRAs, Clinical Pharmacologists, Biomarker/Bioinformatics scientists, Medical Writers, Regulatory representatives, etc.), • Assist in manage data deliverables processes, including database locks, • Ensure data management deliverables are met on time. Utilize communication, available metrics reports, experience, knowledge, and other resources to efficiently lead and coordinate all data management activities. Ensure study team members from different functional areas understand and deliver components affecting data to ensure successful execution of deliverables. Provide solutions for data management issues that arise during study conduct, • Support on the coordination on work performed by vendors/CROs as appropriate to ensure quality of product 🤓 Competencies/Career level Innovation, customer orientation, communication, teamwork, adaptability/flexibility, productivity, Self-development, sense of urgency, initiative. Technologically savvy; quickly picks up new information Accountabilities KPI related to the job. 🕵️Requirements and personal skills • Education: Degree in Engineering, Health data or similar., • Languages: Fluent English, knowledge of other languages will be an asset., • Experience (years/area): 2-3 years of experience in data management. Extensive experience in clinical trial project data management and coordination., • Specific Knowledge: Extensive knowledge of data management and tools., • Travels: Willingness to travel occasionally., • Personal skills: Strong communication and leadership skills. Strong negotiation skills as well as excellent influencing and training/mentoring skills. Ability to focus on multiple deliverables and protocols simultaneously.

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