Group Leader – Study Support Specialist (GLP studies – Product Safety Labs)

Eurofins; Bengaluru; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

Eurofins Bengaluru is seeking a Study Director leader with a toxicology/preclinical background to oversee a team providing GLP-regulated study support. The role emphasizes quality, regulatory compliance, and cross‑functional collaboration across laboratory, QA, and project management.

The ideal candidate has 12–15 years in pre‑clinical studies, IND enabling work, and GLP knowledge. Strong leadership, communication, and organizational skills are essential for ensuring timely delivery and audit

Qualifications

• MS or M.Pharm or PhD with toxicology or preclinical safety
• 12–15 years in pre-clinical studies; IND enabling studies and IND filings
• Knowledge of regulatory requirements (GLP)

Responsibilities

• Lead a team of 4–5 staff; oversee study support activities.
• Collaborate with lab staff to gather study requirements and design details.
• Perform QA reviews of laboratory data, worksheets, and study records for accuracy and audit readiness.
• Monitor milestones, deliverables, and risks to ensure on-time client commitments.
• Coordinate development, review, and issuance of GLP study protocols and amendments.
• Maintain study documentation and tracking for audit readiness and quality standards.
• Assist with shipping documentation and chain-of-custody records.
• Support Study Directors with scheduling, logistics, and cross‑functional communication.
• Track actions and data requests to ensure timely resolution and complete records.
• Provide technical writing support and generate shell documents/tables.
• Suggest process improvements to enhance study execution and data quality.

Skills

Self-management

Detail-oriented

Mathematical ability

Organizational skills

Communication skills

Quality & ethics

Education

MS in Toxicology

M.Pharm

PhD / DABT-equivalent

Job description

Company Description

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.

Job Description

Position Summary:

To better support the Study Director function and allow them to focus on scientific oversight and regulatory accountability. A dedicated leader, ideally a toxicologist, who would oversee a group of support staff responsible for providing the following services:

• Team leadership qualities (coaching and mentoring of staff)
• Managing 4-5 team members along with assigned duties
• 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 authorizations 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, organization of study data packages for report generation, archival, and regulatory inspection readiness.
• Trend study control performance and study outcome.
• 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.
• Review study data to ensure activities were executed according to protocol requirements, SOP, approved timelines, and GLP expectations.
• Participate in process improvement initiatives aimed at enhancing study execution efficiency, data quality, compliance, and client satisfaction.

Qualifications

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)

• Preferred education: M.S., M.Pharm, Ph.D., DABT-equivalent background, or other advanced degree/training relevant to toxicology or preclinical safety assessment. At least 10 years of experience in Pre‑clinical studies / trials, IND enabling studies, IND filing and with knowledge of regulatory requirements (GLP).
• At a minimum, master’s degree in a science‑related (Toxicology would be a best fit) field. 12‑15 years of experience in Pre‑clinical studies / trials, IND enabling studies, IND filing and with knowledge of regulatory requirements (GLP).

Additional Information

Abilities And/||? 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

All candidate CV's and cover letter's will be reviewed, however please note that we are not always able to respond to every expression of interest submitted. Â