CDA II

<p style="text-align:left"><b>Work Schedule</b></p>Standard (Mon-Fri)<p style="text-align:inherit"></p><p style="text-align:left"><b>Environmental Conditions</b></p>Office<p style="text-align:inherit"></p><p style="text-align:left"><b><u>Job Description</u></b></p><p style="text-align:inherit"></p>Join Us as a Clinical Data Assoc II – 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 Clinical Data Assoc II, you will perform advanced aspects of the data cleaning process with a high level of accuracy and in accordance with Good Clinical Practices (GCPs) and Standard Operating Procedures/Work Process Documents (SOPs/WPDs), to assess the safety and efficacy of investigational products and/or medical devices.<br/><br/>What You’ll Do:<br/><br/>• Identify, resolve, and update data discrepancies. Make changes to the data management database as required. <br/>• Generate, track and resolve data clarifications and queries. May implement CRF design in identified graphic design package. <br/>• Review data listings for accuracy and consistency of data. Analyze and resolve data validation and other data management reports. <br/>• Produce project-specific status reports for CDM management and for clients on a regular basis. <br/>• Perform data management activities such as Serious Adverse Event and Third Party Vendor reconciliations as well as Data Listing reviews.<br/><br/>Education and Experience Requirements:<br/>• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification <br/>• Technical positions may require a certificate <br/>• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 6 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 and ability to use interactive computer programs <br/>• Good written and verbal communication skills and a strong command of English language and grammar <br/>• Good organizational and analytical/problem-solving skills <br/>• Ability to work productively with moderate supervision <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, adaptability and ability to work in a team environment or independently as needed <br/>• Must demonstrate good judgment in making decisions <br/>• Knowledge of medical/clinical trial terminology <br/>• Understands project protocol and Data Validation Manual<br/><br/><br/>Working Conditions and Environment: <br/>• Work is performed in an office or clinical environment with exposure to electrical office equipment. <br/>• Occasional drives to site locations. Potential Occasional travel required.<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/>Apply today to help us deliver tomorrow’s breakthroughs.<p></p><p></p><p></p><p></p>