**Descripción breve** --------------------- **Required Qualifications** * **10\+ years of experience in Clinical Data Management**, including roles as CDM, Sr. CDM, and/or Project Manager. * Proven experience in **eClinical and eCOA implementation** across global clinical trials. * Strong command of **EDC systems** such as **Medidata Rave**, **Oracle InForm**, and **Veeva Vault**. * Familiarity with **data standards** (CDISC, SDTM), **medical coding** (MedDRA, WHO Drug), and **regulatory compliance**. * Demonstrated ability to **lead studies independently**, manage complex timelines, and coordinate with global stakeholders. * Experience in **specialty data functions** such as pharmacovigilance, IRT, and lab data oversight. * Excellent **communication, leadership, and problem\-solving skills**. * **PMP certification** is highly desirable. **Key Responsibilities** * **Lead end\-to\-end implementation of eClinical technologies**, with a strong focus on **eCOA platforms**, ensuring alignment with study timelines and regulatory requirements. * **Coordinate cross\-functional teams**, including clinical operations, data management, programming, pharmacovigilance, and external vendors. * **Act as the primary point of contact for sponsors**, overseeing all aspects of study delivery, stakeholder communication, and issue resolution. * **Manage device logistics**, including provisioning, tracking, and troubleshooting of mobile devices used in clinical trials. * **Oversee data integration processes**, ensuring consistency across systems (e.g., EDC, IRT, eCOA, lab platforms). * **Ensure compliance with GCP, ICH, CDISC standards (SDTM), and data privacy regulations** throughout the project lifecycle. * **Identify risks proactively**, propose mitigation strategies, and deliver **executive\-level reporting** on project status, metrics, and budget tracking. * **Support database lock readiness**, including oversight of data cleaning, query resolution, and external data reconciliation (e.g., labs, imaging, SAE). * **Mentor and guide junior CDMs**, fostering team development and ensuring high\-quality deliverables. \#LI\-LM10 **Calificaciones** ------------------ **Responsabilidades del puesto** --------------------------------