Study Director or Study Personnel

Drlogy; Vadodara; On-site; INR 1,000,000 - 1,500,000; Full time

Job summary

Drlogy is seeking a Study Director / Study Personnel for DMPK studies in Vadodara, India. The role involves planning, coordinating, and executing studies related to drug metabolism and pharmacokinetics, ensuring compliance with regulatory standards.

The ideal candidate must possess a strong background in pharmacology and biotechnology. Responsibilities include supervising sample management, data review, training personnel, and maintaining study documentation.

Qualifications

• Strong knowledge of drug metabolism and pharmacokinetics.
• Experience with compliance to GLP and regulations.
• Ability to manage biological samples and data review.

Responsibilities

• Plan and coordinate DMPK studies per protocols.
• Review raw data and study documentation.
• Train junior study personnel on compliance and procedures.

Skills

Knowledge of pharmacology

Biotechnology

Preclinical research

Regulatory expectations

Good Laboratory Practices

Job description

The Study Director / Study Personnel – DMPK Study will be responsible for planning, coordinating, and supporting drug metabolism and pharmacokinetic research studies. This involves study protocol execution, biological sample management, data review, scientific documentation, and cross‑functional coordination. The ideal candidate should have strong knowledge of pharmacology, biotechnology, preclinical research, regulatory expectations, and Good Laboratory Practices to ensure accurate and compliant study delivery.

Responsibilities

• Plan and coordinate DMPK studies in accordance with approved protocols and timelines.
• Support study design for pharmacokinetic, bioavailability, metabolism, and distribution studies.
• Supervise or assist in dosing, sample collection, processing, storage, and shipment activities.
• Review raw data, study observations, analytical results, and supporting documentation.
• Ensure study activities are performed in compliance with GLP, SOPs, and regulatory standards.
• Coordinate with bioanalytical, toxicology, animal facility, QA, and project management teams.
• Prepare or support preparation of study protocols, amendments, reports, and summaries.
• Monitor study progress and resolve operational or scientific issues during execution.
• Ensure proper labeling, tracking, and chain of custody for biological samples.
• Interpret DMPK data and support scientific evaluation of study outcomes.
• Maintain complete study files, raw data, logbooks, and communication records.
• Participate in internal audits and respond to QA observations or documentation queries.
• Train junior study personnel on study procedures, documentation, and compliance requirements.
• Communicate study updates, risks, and timelines to internal stakeholders.
• Ensure confidentiality, data integrity, and ethical conduct throughout the study lifecycle.