[ref. j05284216] São Paulo - Clin Ops Delivery Specialist I
Clin Ops Delivery Specialist I - The RSM-C is capable of leading active and challenging interdepartmental discussions to explore best strategies and practices after understanding trial-specific needs and diverse databases that can be used as sources of information.
Reviews subject data from multiple sources with a data analytic mindset, capable of identifying trends, risks, gaps, and areas for optimization as the subject data and the trial develop.Prepares and analyzes clinical trial patient datasets.
Adapts to constant changes as the trial develops.
Capable of providing concise and clear updates to study teams and other key stakeholders after processing and reviewing subject data.
Continually makes efforts to increase knowledge base and professional skills in areas such as programming, technology and techniques, clinical trials, and the pharmaceutical industry by working closely with mentors, attending presentation/teaching events, and contributing to other general department documents and policies by assisting mentors with implementing best practice documents and articles.
The RSM-Central generates a thorough understanding of protocol schedule of events (visits, activities, and procedures), contracts, budgets, and/or payment terms.Escalates performance issues to clinical, site payments, and IT managers and may assist with resolution (follows escalation pathway as applicable).
Leads internal team meetings and provides updates on subject data statuses.
Manages escalations (project team, site, and sponsor) regarding tracking system setup/maintenance issues.
Qualifications and Skills (some of the below are desired): Bachelor's degree in life science-related fields, Engineering, Biostatistics, and/or Programming or related fields/degrees If possible (but not required), prior clinical research experience or related fields of minimum 6 months to 1 year or related experience involving knowledge of clinical trials.
If possible (but not required), prior experience of minimum 6 months to 1 year on process development or process improvement.If possible (but not required), prior experience of minimum 6 months to 1 year on data assessments, analytics, or critical assessments.
Highly independent and capable of leading multidisciplinary discussions as needed.
Comfortable with decision making and proper documentation practices.
Capable of working under continuous pressure and continuously changing challenges adapting to new priorities and needs as they arise.
If possible (but not required), experience with databases with a scientific background.