Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Join Us as RSM (Level I) - C – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our expert team, you’ll have the opportunity to ensure operational excellence that makes a real difference in organizational performance. As RSM (Level I) - C, you will work highly independently and perform critical assessments to determine the best approaches to automate subject data using multiple pathways and systems. You should be 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.
What You’ll Do:
• 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, such as laboratory data, vital signs data, tumor response data, imaging data, quality of life and well-being questionnaire data, or adverse events data, for clinical research purposes.
• Uses and develops tools and applications to provide the outputs or to validate outputs for clinical use.
• Adapts to constant changes as trial develops and multiple factors and inputs developed by internal or external stakeholders impact subject data.
• 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.
• Reviews and clarifies key aspects with stakeholders from multiple departments to obtain a proper understanding of protocols, site contracts and budgets, eCRFs and other electronic data sources, systems setup and structure, in order to define strategies and propose solution to automate subject data.
• The Clinical Operations Delivery Specialist I has thorough understanding of protocol schedule of events (visits, activities and procedures), Contracts, budgets and payment terms to define data points in electronic data systems to automatize subject creation, visit tracking and activities tracking responsible to trigger site payments.
• 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.
• As a subject data analyst and expert of subject data behavior, the Clinical Operations Delivery Specialist I needs to be capable of performing manual adjustments as needed without compromising data integrity and with little guidance for decision making. Assists with additional activities dependent on subject data integrity and flow which impact downstream processes such as invoice discrepancies, overall subject data trends and queries, data correction and its impact on dependencies.
• Assists in ensuring audit ready files and complying with CTMS and eTMF data stewardship. Contributes to company, client, and federal/local regulatory requirements/audit responses.
Education and Experience Requirements:
• Bachelor's degree in life science-related fields, Engineering, Biostatistics and/or Programing.
• Prior clinical research experience of minimum 3 years and/or knowledge of clinical trials and subject study events.
• Prior experience of minimum 3 years on process development, process improvement; data assessments, analytics and critical assessments.
• Strong leadership skills
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
• 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.
• Experience with Siebel CTMS and/or multiple data bases with scientific background.
• Proven understanding of relational 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 and clients, 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
Why Join Us?
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.
Apply today to help us deliver tomorrow’s breakthroughs.
