Senior CDA/ Clin Data Assoc II

ThermoFisher Scientific; Bengaluru; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Senior Clinical Data Associate in Bengaluru to ensure data integrity and regulatory compliance across clinical trials. You will oversee data cleaning, validation, and database updates with limited supervision, aligning with GCP and SOPs/WPDs. The role supports global data management improvements and client reporting.

Qualifications include a bachelor’s degree and 3–7 years of relevant experience. Occasional travel may be required to site locations.

Qualifications

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
• 3–7 years of relevant experience.
• Equivalency may be accepted where appropriate.

Responsibilities

• Supports study setup including database design, testing entry screens and DVM creation.
• Reviews data listings for accuracy and consistency.
• Acts as SME for specialized study-specific processes.
• Generates and resolves data clarifications and modifies clinical database as required.
• Contributes to improvement of data management processes globally.
• Produces project status reports for management/clients.
• Provides training and work direction to junior staff as required.

Skills

Attention to detail

Communication skills

Analytical thinking

Data management

Clinical terminology

Confidentiality

Time management

Interpersonal skills

Education

Bachelor's degree or equivalent

Job description

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.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.