Senior CDA

<p></p><p>Join Us as a Senior Clinical Data Associate – Make an Impact at the Forefront of Innovation<br />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.<br /><br />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.<br />What You’ll Do:<br />• Supports the setup of study activities such as database design, testing of data entry screens, and Data Validation Manual (DVM) creation, as required.<br />• Reviews data listings for accuracy and consistency of data.<br />• Acts as point person and subject matter expert for specialized study-specific processes.<br />• Generates, tracks and resolves data clarifications and queries and makes changes to the clinical database as required.<br />• Contributes to the improvement of data management processes on a global level.<br />• Produces project-specific status reports for management and/or clients on a regular basis.<br />• Provides training and work direction to junior staff as required.<br /><br />Education and Experience Requirements:<br />• Bachelor's degree or equivalent and relevant formal academic / vocational qualification<br />• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years).<br />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.<br /><br />Knowledge, Skills and Abilities:<br />• Applies knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, global SOPs and client expectations<br />• Strong attention to detail and skill with numbers<br />• Good written and verbal communication skills<br />• Good analytical/problem-solving skills<br />• Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data<br />• Strong customer focus and excellent interpersonal skills.<br />• Proven flexibility and adaptability<br />• Must be able to set and meet timelines or be able to negotiate schedule changes in response to project demands<br />• Knowledge of medical/clinical terminology<br />• Understands project protocol and DVM<br />• Proven ability in achieving applicable technical competencies per the DM competency grid<br /><br /><br />Working Conditions and Environment:<br />• Work is performed in an office environment with exposure to electrical office equipment.<br />• Occasional drives to site locations<br />• Occasional travel both domestic and international.<br /><br />Why Join Us?<br /><br />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.<br /><br /></p>