Work Schedule

Environmental Conditions

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 Patient Data Specialist 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.

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 Patient Data Specialist generates a thorough understanding of protocol schedule of events (visits, activities and procedures), EDC, Systems, Contracts, budgets and/or payment terms. 

The Patient Data Specialist is able to understand target systems requirements to define a study specific setup. Similarly, the Patient Data Specialist is capable to lead discussions with Contracts teams and Data Management teams to facilitate the optimal design of budgets and Data bases which will be compatible with the tools and target systems managed by the Patient Data Team.

During the maintenance phase, the Patient Data Specialist may be responsible of highly complex studies that may not be compatible with our standard data processing tools and may lead efforts to define a case specific approach to process data to feed downstream systems. These efforts may require constant manual checks and manipulations to guarantee a proper processing.

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. Continuously monitors proactively and independently the performance of a project and adjusts systems setups as needed. 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
• Prior clinical research experience or related fields of minimum 1 year or related experience involving knowledge of clinical trials.
• Prior experience of minimum 6 months to 1 year on process development or process improvement.
• 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 continuous changing challenges adapting to new priorities and needs as they arise.
• 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