Senior CDA/ Clin Data Assoc II

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 3 to 7 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.