Clinical Data Coordinator

Thermo Fisher Scientific • Austin, TX

2d • Onsite

About The Position

Join Us as a Clinical Data Coordinator – 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 Clinical Data Coordinator, 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.

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.
• 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

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level