Clinical data associate 1 (thermofisher)

Roles and Responsibilities

Job Description

CDA I:

Join Us as a Clinical Data Associate I – Make an Impact at the Forefront of Innovation. We have successfully supported the top 50 pharmaceutical companies and more than 750 Bio-techs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

Role Overview:

This role is responsible for entry-level clinical data cleaning and reconciliation activities performed with high accuracy and in accordance with GCP, SOPs/WPDs, and study protocols. You will collaborate with cross-functional study teams to ensure data integrity, timely issue resolution, and inspection-readiness of study data throughout the study lifecycle.

What You’ll Do:

• Identifies, resolves, and updates data discrepancies. Makes changes to the data management database as required.

• Generates, tracks and resolves data clarifications and queries.

• May implement CRF design in identified graphic design package.
  

Education and Experience Requirements:

• Bachelor's degree or equivalent and relevant formal academic

• Previous experience (Min 1 to 1.6 Years) that provides the knowledge, skills, and abilities to perform the job

• Should have experience in RAVE / Veeva EDC

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
• Ability to use interactive computer programs
• Good written and verbal communication skills and a strong command of English language and grammar
• Good analytical /problem-solving skills
• Ability to work productively with direct supervision
• Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data
• Proven flexibility and adaptability
• Ability to work in a team environment and independently as needed
• Must demonstrate good judgment in making decisions
• Understands project protocol and Data Validation Manual


Working Conditions and Environment:
• Work is performed in an office or clinical environment with exposure to electrical office equipment.
• Occasional drives to site locations. Potential Occasional travel required.