 
The Senior Clinical Data Analyst (SCDA) independently performs, leads, and coordinates all clinical data validation activities on assigned projects with a high degree of proficiency and autonomy. Responsibilities include providing technical expertise and operational leadership for all DM operational activities (data cleaning matrices), processes, and Data Management documents regarding data validation. Tasks should be performed according to corporate quality standards, SOPs/Work Instructions/Guidelines, ICH-GCP, and/or other international regulatory requirements. The 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 also fulfill the Data Management Lead role where required.
Accountabilities:
- Data Validation (Cleaning): Lead data validation activities during conduct and database lock, including query management, manual/SAS listing reviews, and external vendor data reconciliation. Highlight issues/risks to delivery and support mitigations as part of the Risk Management Plan.
- Data Management Documents/Plans (Trial Master File): Setup and ensure proper documentation as per SOPs, ICH/GCP Guidelines.
- Study Start-Up Activities and User Acceptance Testing (UAT): Lead/perform UAT on clinical database setups. Review protocols and EDC Entry Screens if required. Provide input on data management timelines and coordinate DM operational activities during database setup, up to project close-out.
- Data Tracking and Entry: Track and review CRFs. Support data entry where required.
- Project Quality Management & Compliance: Ensure compliance with SOPs, ICH/GCP Guidelines. Perform/lead functional QC activities on databases and/or patient data as needed.
- Training: Maintain training compliance, address training needs, provide relevant on-the-job training, act as a mentor, and serve as a Subject Matter Expert regarding DM operational tasks/tools/processes/systems.
- Process/Project Improvement: Develop, improve, and implement project-specific tools for improved efficiencies.
- Project Finance & Resource Support: Determine root cause of operations-related project variance and provide input on scope changes as needed.
Skills:
- Proven leadership and collaboration with global and cross-functional teams
- Ability to coordinate and prioritize tasks
- Strong negotiation, problem-solving, and logical reasoning skills
- Commitment to first-time quality with a methodical, analytical approach
- Advanced interpersonal, oral, and written communication skills
- Good presentation skills
- Proven learning ability and knowledge-sharing approach
- Flexibility with respect to work assignments and new learning
- Strong sense of accountability and innovative approach
Knowledge and Experience:
- Advanced technical aptitude and experience with Microsoft Office Products
- Advanced understanding of data management processes and data validation flow
- Good understanding of relevant ICH-GCP Guidelines, local regulatory requirements, Parexel SOPs, and study-specific procedures
- Advanced knowledge of Clinical Data Management Systems (e.g., InForm, Rave, Veeva, DataLabs, ClinBase)
- Good understanding of Clinical Study Team roles within Data Management
- Experience in the clinical research industry
- Advanced knowledge of medical terminology and coding dictionaries (e.g., MedDRA & WHODRUG)
- Advanced knowledge of Database setup activities and Data Management Operational processes
- Basic knowledge of SAS and Data standards (CDISC)
- Good understanding of financial principles for managing DM project financials
- Proven experience in leading virtual/global Data Management operational teams
