Job Description
Job Description
Works highly independent 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 active and challenging interdepartmental discussions to explore best strategies and practices after understanding trial specific needs and diverse data bases that can be used as source 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 trial develops. Capable of providing concise and clear updates to study teams and other key stakeholders after processing and reviewing subject data.
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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). Lead internal team meetings and provide updates on subject data statuses. Manage 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 Programing 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 1year on process development or process improvement.
- If possible (but not required), prior experience of minimum 6 months to 1year 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 continuous changing challenges adapting to new priorities and needs as they arise.
- If possible (but not required), experience with data bases with scientific background.
Skills
- Understanding of data base 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 communications 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