Senior CDA, Client Facing – Min 5+ Years Data Management Experience
Posted 12hrs ago
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Job Description
Senior Clinical Data Associate leading data management, testing, reconciliation, and QC for Syneos Health’s global clinical trials. Home-based in Argentina, mentoring CDAs and supporting Project Data Managers.
Responsibilities:
- Lead other Clinical Data Associates in all data management activities for global clinical trials
- Provide support and act as backup for the Project Data Manager as required
- Maintain awareness of contract and scope-of-work requirements and communicate status updates
- Review and adhere to study-specific Data Management Plans
- Create test data and perform User Acceptance Testing for data entry screens, edit checks, listings, study roles, and SDV configurations
- Review discrepancy outputs and validation listings; query discrepancies and apply permitted self-evident corrections
- Resolve and re-query answered queries where appropriate
- Perform quality control checks for paper and EDC studies
- Coordinate paper-study quality control and document filing
- Participate in internal meetings, in-process reviews, audits, and inspections
- Maintain proficiency in data management systems and processes through training
- Perform SAS mapping quality-control checks
- Oversee, train, mentor, and review the work of other Clinical Data Associates
- Reconcile external databases and datasets with clinical database data
- Run data-cleaning and status reports and perform Serious Adverse Event reconciliations
- Liaise with Clinical Programming, Biostatistics, and Clinical Operations
- Create ad-hoc data-cleaning reports and specifications for validated listings
- Perform post-migration testing
- Participate in customer and third-party meetings and distribute accurate meeting minutes
- Review database design specifications and design or review CRFs/eCRFs
- Provide input into Data Validation Specifications and edit checks
- Produce study metrics reports and support Project Data Manager activities
- Create Discoverer, BOXI, and J-Review reports
- Create, update, and review study-specific documents and data-transfer requests
- Review queries and self-evident corrections proposed by less experienced data-management staff
- Provide EDC training to internal and external team members
- Serve as a platform- or process-specific Subject Matter Expert
- Perform quality control of the Data Management Study File during study conduct
- Represent the department at business-development meetings when required
- Perform activities in compliance with corporate practices, SOPs, and work instructions
Requirements:
- Minimum 5+ years of previous data management experience
- BA/BS degree in biological sciences or related natural science/healthcare disciplines
- Advanced English level
- Prior experience in therapeutic area Oncology
- Knowledge of clinical data and ICH/Good Clinical Practices
- Proficiency navigating MS Windows and using MS Word, Excel, and email applications
- Excellent keyboard speed and accuracy
- Familiarity with medical terminology
- Excellent written and spoken communication, presentation, and interpersonal skills
- Good organizational, planning, and time-management skills
- Ability to multitask under tight deadlines with attention to detail
- Ability to work independently and as part of a multidisciplinary team
- Ability to perform a leadership function in data management, including effective mentoring
- Ability to deal effectively with sponsors and internal customers
- Experience with data-management practices and relational database-management software preferred
- Oracle Clinical, Rave, or Inform systems experience preferred
- Work experience in clinical research, drug development, data management, or another healthcare environment preferred
- Ability to be flexible and adapt to change
- Responsible for compliance with applicable corporate business practices, SOPs, and work instructions
Benefits:
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Inclusive culture
- Comprehensive resources including emerging technologies, data, science and knowledge sharing
- Opportunities for specialized therapeutic or functional team collaboration
- Exposure to multiple career paths and employment opportunities
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