Clinical Data Associate

Thermo Fisher Scientific India Pvt Ltd; Bengaluru; Hybrid; INR 350,000 - 600,000; Full time

Job summary

Thermo Fisher Scientific India Pvt Ltd is seeking a Clinical Data Associate I to support data cleaning and validation activities within GMP-compliant processes. The role involves ensuring data accuracy and timely resolution of data queries in an office environment and may include limited site travel.

Responsibilities include identifying discrepancies, tracking clarifications, and potentially contributing to CRF design documentation as part of the data management workflow.

Qualifications

• High or secondary diploma or equivalent with relevant formal qualification.
• Technical positions may require a certificate.
• Equivalent education/experience considered acceptable.

Responsibilities

• Identify, resolve, and update data discrepancies in the database.
• Generate, track, and resolve data clarifications and queries.
• May implement CRF design in identified graphic design package.

Skills

Data accuracy

Data management

Attention to detail

English proficiency

Regulatory compliance

Education

High/Secondary diploma

Technical certificate (optional)

Job description

CDA I Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description 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 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our global team, you’ll have the opportunity to perform entry-level aspects of the data cleaning process with a high level of accuracy and in accordance with GCPs and SOPs/WPDs to assess the safety and efficacy of investigational products and/or medical devices.

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:

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
• Technical positions may require a certificate
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 4 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
• 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.