When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Parexel are recruiting for multiple Senior Clinical Data Analyst to support our FSP team. This is a remote role, we are open to candidates based anywhere in Argentina, Brazil, Mexico and Colombia.
The Senior Clinical Data Analyst (SCDA) independently performs/lead and/or coordinate all clinical data validation activities on assigned projects, commensurate with experience and/or project role, with high degree of proficiency and autonomy. Further responsibilities shall include providing technical expertise and/or operational leadership regarding all DM operational activities (data cleaning matrices), processes and Data Management documents regarding data validation. All tasks should be performed in accordance to corporate quality standards, SOPs/Work Instructions/Guidelines, ICH-GCP and/or other international regulatory requirements.
SCDA acts as a subject matter expert on DM Systems/processes, providing technical support and expert advice to internal and external sponsors.
The SCDA may act as a back-up to or fulfill the Data Management Lead role where required.
Key Accountabilities:
Accountability
Data Validation (cleaning)
• Lead/Responsible for data validation (cleaning/review/reconciliation) activities during conduct and database lock (Primary CDA), e.g. query management, manual/SAS listing reviews and external vendor data reconciliation.
• Highlight issues/risks to delivery by understanding interdependencies - support mitigations as part of Risk Management Plan.
Data Management Documents/Plans (Trial Master File)
• Perform and/or support the setup of DM documents and ensure proper documentation as per Standard Operating Procedures, ICH/GCP Guidelines.
Study Start-Up Activities and User Acceptance Testing (UAT)
• Lead/perform user acceptance testing on clinical database setups.
• Review protocols and EDC Entry Screens if required.
• Provide input on and tracking the data management timelines and coordinate the DM operational activities during database set up, up to project close out.
Data Tracking and Entry
• Track and review CRFs. Support data entry where required
Project Quality Management & Compliance
• Ensure compliance to Standard Operating Procedures, ICH/GCP Guidelines.
• Perform/Lead functional QC activities on databases and/or patient data, as per business needs.
Training
• Maintain training compliance as per Job Roles assigned, including On-the-Job training.
• Address training needs, as per Development Goal/s identified.
• Provide relevant on-the-job training to staff and project teams as appropriate
• Act as Mentor for other clinical data analysts.
• Act as Subject Matter Expert regarding DM operational tasks/tools/ processes/ systems.
Process/Project Improvement
• Develop, improve and implement project specific tools, including, but not limited to standard project directories and subdirectories, document file names and status reports that result in improved efficiencies.
Project Finance & Resource Support
• Determine root cause of operations-related project variance in a timely manner, based on DM operational metrics/labor hour reports - provide input on Changes in Scope needed.
Skills:
• Written and oral fluency in English.
Knowledge and Experience:
• Advanced technical aptitude with awareness/potential prior experience in Microsoft Office Products (strong computer skills).
• Advanced understanding of data management processes and data validation flow (e.g. Data cleaning, DB lock).
• Good understanding of relevant ICH-GCP Guidelines, local regulatory requirements and PAREXEL SOPs and study specific procedures.
• Advanced knowledge of Clinical Data Management Systems and proficiency in at least one system (e.g. InForm, Rave, Veeva, DataLabs, ClinBase.)
• Good understanding of Clinical Study Team roles within Data Management - awareness of DML activities e.g.: budget reviews, resource forecast, etc.
• Experience in clinical research industry.
• Advanced knowledge of medical terminology and coding dictionaries (e.g. MedDRA & WHODRUG).
• Advanced knowledge of Data Management Operational processes and tasks during study start-up, conduct and close-out.
• Advanced knowledge of Database set-up activities, including but not limited to Database Configuration Specifications and setup of Data Validation.
• Basic knowledge of SAS (programmed listings).
• Basic knowledge of Data standards (CDISC).
• Good understanding of financial principles/drivers for management of DM project financials with regards to forecasting and scope of work.
• Proven experience of leading virtual/global Data Management operational team/s to perform DB set up, data cleaning activities.
Education:
• Bachelor’s degree and / or other medical qualifications or relevant industry experience.
