Senior CDA/ Clin Data Assoc II

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Senior Clinical Data Associate – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our expert team, you’ll have the opportunity to ensure operational excellence that makes a real difference in organizational performance. As a Senior Clinical Data Associate, you will perform all aspects of the data cleaning process, with minimal supervision, in accordance with Good Clinical Practices (GCP) and Standard Operating Procedures/Work Process Documents (SOPs/WPDs), to assess the safety and efficacy of investigational products and/or medical devices. What You’ll Do: • Supports the setup of study activities such as database design, testing of data entry screens, and Data Validation Manual (DVM) creation, as required. • Reviews data listings for accuracy and consistency of data. • Acts as point person and subject matter expert for specialized study-specific processes. • Generates, tracks and resolves data clarifications and queries and makes changes to the clinical database as required. • Contributes to the improvement of data management processes on a global level. • Produces project-specific status reports for management and/or clients on a regular basis. • Provides training and work direction to junior staff as required. Education and Experience Requirements: • Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: • Applies knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, global SOPs and client expectations • Strong attention to detail and skill with numbers • Good written and verbal communication skills • Good analytical/problem-solving skills • Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data • Strong customer focus and excellent interpersonal skills. • Proven flexibility and adaptability • Must be able to set and meet timelines or be able to negotiate schedule changes in response to project demands • Knowledge of medical/clinical terminology • Understands project protocol and DVM • Proven ability in achieving applicable technical competencies per the DM competency grid Working Conditions and Environment: • Work is performed in an office environment with exposure to electrical office equipment. • Occasional drives to site locations • Occasional travel both domestic and international. Why Join Us? When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference. Apply today to help us deliver tomorrow’s breakthroughs.