Study Support Specialist (GLP studies – Product Safety Labs)

SmartRecruiters, Inc.; Bengaluru; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Eurofins Scientific seeks a Study Support Specialist for GLP studies in Product Safety Labs. In this full-time role, you will assist Study Directors by gathering study requirements, coordinating protocols, and maintaining audit-ready documentation across labs.

Ideal candidates hold a Master’s in a science field and 5–7 years of pre-clinical experience, with strong organizational, analytical, and communication skills to ensure on-time delivery and compliance with GLP.

Qualifications

• Master’s degree in a science-related field with 5–7 years in pre-clinical studies.
• Knowledge of GLP requirements and regulatory guidelines.
• Ability to manage documentation and audit readiness across studies.

Responsibilities

• Collaborate with lab staff to gather study requirements and design details.
• Conduct quality control reviews of study records for accuracy and completeness.
• Monitor milestones and coordinate study protocols and documentation.
• Maintain audit-ready study files and shipping/chain-of-custody records.
• Support with scheduling, logistics, and cross-functional communication.

Skills

Detail Oriented

Strong Organizational Skills

Strong Communication

Self-Management

Mathematical Aptitude

Education

Master's degree in a science-related field

Job description

Study Support Specialist (GLP studies – Product Safety Labs)

• Full-time

ENGLISH

Eurofins Scientific is an international life sciences company, which provides a unique range of analytical testing services to clients across multiple industries. The Group believes it is the world leader in food, environment, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and for supporting clinical studies. In addition, Eurofins is one of the leading global emerging players in specialty clinical diagnostic testing.

In 2020, Eurofins generated 5.4 billion Euro proforma turnover in 800 laboratories across 50 countries, employing about 50.000 staff.

Position Summary

To better support the Study Director function and allow them to focus on scientific oversight and regulatory accountability.

Essential Duties and Responsibilities

• Collaborate with lab staff to gather study requirements, test article information, and study design details necessary for study initiation, laboratory assignment, and resource planning.
• Conduct quality control reviews of laboratory data, worksheets, and study records to ensure accuracy, completeness, consistency, and readiness for Study Director review which will include long-term and complex studies generating extensive datasets.
• Monitor study milestones, deliverables, and critical path activities to proactively identify risks, communicate potential delays, and support on-time completion of client commitments and regulatory deadlines.
• Coordinate the development, review, revision, and issuance of study protocols, amendments, and associated study documentation in accordance with GLP requirements and internal procedures.
• Maintain study documentation and tracking systems, ensuring study files remain audit-ready and compliant with applicable quality standards throughout the study lifecycle.
• Assist with the preparation of shipping documentation and return authorisations for test articles, samples, and retained materials, while obtaining, reviewing, and maintaining chain-of-custody records and shipment tracking information.
• Support Study Directors with scheduling, study logistics, sample management, and cross-functional communication among laboratory, quality assurance, and/or project management.
• Track study-related actions, deviations, data requests, and outstanding documentation to ensure timely resolution and complete study records.
• Assist with the compilation, review, and organization of study data packages for report generation, archival, and regulatory inspection readiness.
• Provide technical writing support for projects which may include generating shell documents and tables of data that was collected over the course of a study.
• Trend study control performance and study outcome.
• Review study data to ensure activities were executed according to protocol requirements, SOP, approved timelines, and GLP expectations.

Basic Minimum Qualifications (BMQ)

To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements below are representative of the knowledge, skill or ability required.

Education/Experience (BMQ)

Master’s degree in a science‑related (Pharmacology / Toxicology would be a best fit) field with 5-7 years of experience in Pre‑clinical studies / trials, IND enabling studies, IND filing and with knowledge of regulatory requirements (GLP).

Abilities and/or Skills

• Honest, Dependable, Demonstrated Ability to Self‑Manage
• Detail Oriented, Accurate, Precise
• Strong Math Skills
• Strong Organizational Skills
• Logical Thinking, Good Reasoning Ability
• Strong communication including verbal, writing, and presentation skills
• Dedication to quality, ethics, and customer service
• Ability to handle personal stress
• Mental and emotional stability and maturity
• Motivation to excel
• Should able to sit for long periods as per role requirement