PRR Project

Summary

FMUP is seeking a dedicated individual to join the RISE team as a Clinical Research Program Manager, specializing in Cardiovascular Sciences and Clinical Research. This pivotal role involves overseeing the management of clinical research projects, leading a team of Health Technicians/research members, and ensuring the successful execution of clinical research activities. Key responsibilities includeLead and coordinate clinical research programs in cardiovascular sciences, ensuring alignment with strategic objectives, adherence to timelines, and achievement of milestones.Serve as a motivational leader for a team of Health Technicians, providing guidance, support, and mentorship to optimize team performance and productivity.Develop, monitor, and manage program budgets, including resource allocation and overseeing procurement processes for goods and services acquisition.Recruit, allocate, and manage human resources for cardiovascular research programs, ensuring optimal utilization of personnel.Navigate ethical issues specific to clinical research, including submission to local or national ethics committees. Proficient with the Clinical Trials Information System from the European Medicines Agency (CTIS/EMA) platform for regulatory compliance in case of randomized clinical trials using medicines or devices.Implement strategies for data protection, risk assessment, safeguarding participant confidentiality and integrity, and project quality.Oversee the management of study materials and dossiers for clinical research projects, ensuring accurate documentation and compliance with regulatory requirements.Coordinate the preparation, review, and dissemination of scientific reports and documents pertaining to cardiovascular research, including study protocols, informed consent forms, other patients’ material, progress reports, including safety, and regulatory submissions.Develop plans for program outcomes and monitor progress towards research deliverables, adjusting as necessary to ensure program success.Engage with key stakeholders in the cardiovascular research community, including industry sponsors, hospital centers (administration council and research team), finance departments, insurance companies, regulators and ethics, patients, technology/devices companies, contract research organizations, pharmacovigilance departments, study monitors and other researchers to foster collaboration and to ensure alignment with program/research objectives.Provide lectures and supervise students, including overseeing last year´s projects, theses, and dissertations. Scientific ProfileThe candidate for this position should possess the following qualifications:Ph.D. degree in Cardiovascular Sciences with Health Sciences background and specialization in Clinical ResearchProven experience in program management and leadership roles within cardiovascular research settings, with a track record of successful project delivery.Understanding ethical considerations and regulatory requirements specific to cardiovascular research, with experience using CTIS/EMA for clinical trials submission according to Clinical Trials Regulation (EU No 536/2014).Strong organizational skills and attention to detail, with the ability to manage complex/ multi-center cardiovascular research programs and multidisciplinary teams effectively.Excellent communication and interpersonal skills, with the ability to engage with diverse stakeholders and foster collaboration within the cardiovascular research community.Proficiency in data management, biostatistics, and scientific/medical writing, with a focus on cardiovascular research methodologies and analysis techniques.Experience in lecturing and mentoring/supervising integrated masters, 2nd and 3rd cycle theses. RationaleCardiovascular diseases represent a significant burden on global health, constituting one of the leading causes of morbidity and mortality worldwide. Hiring a Clinical Research Program Manager specialized in Cardiovascular Sciences will enable FMUP to address critical health challenges and contribute to improved cardiovascular outcomes driven by research of excellence and innovation. His/her expertise in study design, protocol development, and logistical coordination ensures the seamless execution of research studies, maximizing the potential for meaningful discoveries with real-world implications. The translation of research ideas and questions to a real, practical, and well-designed research study, including all logistic aspects, is crucial, and the candidate will play a central role in ensuring that research endeavors are not only scientifically rigorous but also practically relevant and feasible. By fostering synergy between clinicians, basic scientists, epidemiologists, and other stakeholders, the candidate will amplify the impact of research efforts and accelerate progress toward improved cardiovascular health outcomes.