Syneos Health
10,000+ employees
🏥 Healthcare
💼 Consulting
📦 Logistics
Healthcare • Consulting • Logistics
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.
Senior CDA, Client Facing – Min 5+ Years Data Management Experience
🔥 0 minutes ago
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Syneos Health
10,000+ employees
🏥 Healthcare
💼 Consulting
📦 Logistics
Healthcare • Consulting • Logistics
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.
📋 Description
• 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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