CDA II - Veeva
Full-time
Description
<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><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:</p><p></p><ul><li>• Life Science Graduation in Preferred</li><li>Should have 4+ Yers of experience in Clinical Data Manager role</li><li>Should have experience in Veeva EDC</li></ul><p></p><p>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></p>
Pipeline
Retrospective Cohort EnrollmentN/A
Technical Evaluation of Brahms PCT DirectN/A
Blood sample collectionN/A
Blood samplingN/A
RimegepantN/A