Senior CDA

Job Description :

Work Schedule

Environmental Conditions

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.