Sr Clin Data Assoc

ThermoFisher Scientific; Buenos Aires; Presencial; ARS 57.911.000 - 70.103.000; Jornada completa

Descripción de la vacante

Thermo Fisher Scientific in Buenos Aires, Argentina is seeking a Senior Clinical Data Associate to ensure clinical data quality and integrity across trials. You will perform data cleaning with minimal supervision, adhering to GCP and SOPs, and support data validation activities to assess safety and efficacy of investigational products.

The role involves setting up study activities, reviewing data listings, and acting as SME for study-specific processes.

Formación

• Bachelor's degree or equivalent in a life sciences field.
• 0-2 years of relevant clinical data management experience.
• Equivalency considered with education, training, or related experience.

Responsabilidades

• 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.

Conocimientos

Attention to detail

Written and verbal communication

Analytical/problem-solving

Regulatory compliance

Data management

Confidentiality handling

Educación

Bachelor's degree or equivalent in a life sciences field

Descripción del empleo

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 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.

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.