Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Works independently and performs critical assessments in collaboration with study teams or other departments to determine best approaches to manipulate subject data. The RSM-C is capable of leading 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 develops. 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, programming, or related fields/degrees.
Prior clinical research experience or related fields of minimum 6 months to 1 year is preferred.
Prior experience of minimum 6 months to 1 year in process development or process improvement is preferred.
Prior experience of minimum 6 months to 1 year in data assessments, analytics, or critical assessments is preferred.
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 adapting to new priorities and needs as they arise.
Experience with databases with a scientific background is preferred.
Skills:
Understanding of database structure and complex data systems.
Proven understanding and use of Microsoft Excel.
Capable of effectively capturing and reviewing data.
Capable of providing quality control support.
Good attention to detail.
Good problem-solving skills.
Excellent written and verbal communication skills to effectively interface with teams, including proficiency in the English language.
Capable of effectively organizing and managing multiple assignments with challenging timelines.
Capable of adapting and adjusting to changing priorities.
Positive attitude and the ability to work well with others.
Demonstrate initiative and self-motivation.
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