Job Title: Study Director

Experience: 4+ Years

Qualification: M.V.Sc / M.Pharm / M.Sc (Life Sciences)

Job Summary:

We are looking for a Study Director with 4+ years of experience in conducting GLP studies in compliance with OECD Principles of GLP & CCSEA guidelines.

Key Responsibilities:

- Overall conduct and management of GLP studies as Study Director.
- Preparation, review and approval of Study Plan, Amendments & Final Reports with dated signatures.
- Ensure study is conducted as per Study Plan, SOPs and GLP requirements, with complete documentation of raw data & deviations.
- Coordinate with QAU for timely submission of Study Plan/Amendments and ensure QAU statement in final report.
- Ensure availability of validated systems, calibrated instruments, adequate resources, test systems & test materials.
- Responsible for multi-site study coordination,



defining roles of PI and test sites.
- Preparation and approval of Form-B before study initiation and maintenance of Form-D register as per CCSEA.
- Preparation of SOPs, training of study personnel and maintenance of personnel files.
- Ensure proper archiving of Study Plan, Raw Data, Reports & supporting materials after study completion.
- Handle any other responsibilities assigned by TFM.

Required Skills: OECD GLP, CCSEA Guidelines, Study Plan & Report Preparation, SOP, QAU Coordination, Form-B/Form-D

Pay: ₹20,000.00 - ₹55,000.00 per month

Advantages

- Commuter assistance
- Paid time off
- Provident Fund

Work Location: In person

📌 Study Director - Toxicology (Barwala)
🏢 Aal Biosciences Research
📍 Barwala