Clinical Research Projects Specialist

OBJECTIVE OF THE POSITION: Ensure the compliance of deadlines, budgets and quality standards established to ensure excellence in project delivery. Ensure that communication is aligned with regulatory norms and clinical best practices (GCP). Identify and propose strategic solutions, promoting operational efficiency throughout all project phases, acting proactively by identifying risks ahead of time. MAIN ACTIVITIES AND RESPONSIBILITIES: Lead all the activities related to the planning, coordination and execution of clinical research projects, ensuring compliance with regulatory requirements, GCP guidelines and internal procedures. Coordinate and collaborate with cross-functional teams, including researchers, clinicians, statisticians and other stakeholders to ensure project deliverables are met. Develop and maintain relationships with clients, sponsors and partners to ensure successful project outcomes. Ensure the quality and integrity of data collected during clinical research projects, ensuring compliance with regulatory requirements and GCP guidelines. Identify and mitigate risks associated with clinical research projects, ensuring that all necessary measures are taken to prevent or minimize potential issues. Provide guidance and support to team members on clinical research methodologies, protocols and procedures. Develop and implement process improvements to enhance operational efficiency and reduce costs. Ensure the timely and accurate submission of project reports, including study protocols, case report forms, and other relevant documentation. Coordinate and participate in internal and external audits, ensuring compliance with regulatory requirements and GCP guidelines. Provide training and support to team members on clinical research regulations, GCP guidelines and internal procedures. Develop and maintain a comprehensive understanding of clinical research regulations, GCP guidelines and industry best practices.