Senior Clinical Data Manager

The role We are looking for an experienced Senior Clinical Data Manager to join our Clinical Data Management team. In this role, you will coordinate and lead data management activities for complex clinical trials, ensuring the delivery of high-quality data in compliance with protocol requirements, applicable regulations, and established timelines. You will work closely with multidisciplinary teams, sponsors, and external vendors to develop and implement effective data management strategies throughout the entire study lifecycle, from start-up through database lock and study close-out. Depending on your experience and interests, you will have the opportunity to mentor and coordinate more junior team members, contribute to process optimization initiatives, and participate in business development and client relationship activities. This position can be performed remotely or in a hybrid work environment in Romania. Key Responsibilities Lead Clinical Data Management activities for assigned studies. Develop and maintain study-specific documentation. Coordinate database design, configuration, and testing processes. Oversee data review, validation, and cleaning activities. Manage the integration and reconciliation of data from external sources. Monitor study quality metrics and progress indicators. Identify and manage risks that may impact data quality or project timelines. Participate in and lead meetings with internal teams, sponsors, and vendors. Ensure readiness for audits and inspections. Provide mentoring and support to less experienced team members. Contribute to continuous improvement initiatives for departmental processes and standards. This role may be a good fit for you if you: Have at least 5 years of experience in Clinical Data Management and international clinical trials. Have successfully led data management activities for Phase I-IV clinical trials in a CRO, biotechnology, or pharmaceutical environment for at least 2 years . Have hands-on experience across all stages of data management, including: Database design and setup; User Acceptance Testing (UAT); Data review and cleaning; Data reconciliation; Database lock and study close-out activities. Have experience managing multiple data sources and external vendors, including central laboratories, eCOA/ePRO, eDiary, ECG, imaging, and IxRS/IRT systems. Have knowledge of CDISC standards , including CDASH and SDTM . Have experience developing data management documentation such as Data Management Plans , Edit Check Specifications , and Completion Guidelines . Have worked with EDC systems and clinical data monitoring and analysis tools (preferably Viedoc, Veeva, or Medidata Rave ). Understand clinical trial methodology, medical terminology, and ICH-GCP requirements . Have experience collaborating with global and cross-functional teams. Communicate effectively and have experience interacting directly with sponsors and vendors. Are organized, detail-oriented, and able to manage multiple projects and priorities simultaneously. Nice to Have Experience in oncology clinical trials . Experience with complex global Phase II and Phase III studies. Knowledge of Centralized Monitoring or Risk-Based Monitoring (RBM) . Familiar with data reporting, analytics, and visualization tools. What we offer: · A dynamic and innovative workplace that embraces new ideas. · The chance to be part of an effective, dynamic, friendly, and supportive team. · Work with new and exciting technologies. · Development opportunities. For more information about HiRO Company, please visit our page : https://harvestiro.com/