Job Description

Works highly independent and performs critical assessments to determine best approaches to automate subject data using multiple pathways and systems. 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, 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 RSM-Central 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 RSM-C 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. 

Qualifications and Skills

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.Prior experience of minimum 3 years on data assessments, analytics and 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.Experience with Siebel CTMS and/or multiple data bases with scientific background.

Skills

Proven understanding of relational data base structure and complex data systemsProven understanding and use of Microsoft Excel Capable of effectively capturing and reviewing dataCapable of providing quality control support Good attention to detailGood problem-solving skillsExcellent written and verbal communications skills to effectively interface with teams and clients, including proficiency in the English languageCapable of effectively organizing and managing multiple assignments with challenging timelinesCapable of adapting and adjusting to changing prioritiesPositive attitude and the ability to work well with othersDemonstrate initiative and self-motivation