***** Remote Only *****Over 15 years of extensive clinical-trial experience, a working knowledge of data management and GCP and ICH guidelines, as well as excellent teamwork skills. I have proven ability to combine the leadership skills of a line manager with the data expertise and discipline of a clinical data manager. As such, I oversee the activities of direct reports and serve as a mentor. I am also responsible for creating the CRFs and ensuring that all protocol required assessments are being collected and the database is built according to specifications. Key qualifications:• Excellent attention to detail, and strong analytical and problem solving skills. • Proven leadership skills • Knowledge of relational databases and database design. • Understanding of clinical research processes, ICH and GCP guidelines• Strong knowledge of CRF design and relation to the protocol and clinical trial database. • Excellent organizational skills to meet timelines and handle multiple projects. • Ability to work both independently and as a team member. • Effective interpersonal and communications skills.SPECIALTIES: leadership and coaching skills, matrix organization, project management skills, GCP/ICH guidelines, CRF Design, DB development, tables and listings, validations, derivations, database, SAE reconciliation, discrepancy management