Job Description
Company Description
Eurofins Advinus is a premier preclinical and early development CRO offering drug discovery, preclinical and development stage contract research services in the areas of discovery services, regulatory Toxicology (Safety Assessment), DMPK, Analytical R&D Services and API CDMO. Eurofins Advinus manufactures drug substances to support Toxicology and early clinical studies.
With over 30 years of GLP compliance and certification, Eurofins Advinus serves diverse industries such as Biotech, Pharmaceutical, Biological, Agrochemical, Nutraceutical and Cosmetic. Eurofins Advinus is the only contract research organization (CRO) in India to have developed data in support of 90+ end-to-end IND enabling packages to be submitted to global regulators such as USFDA, EMA, MHRA, Health Canada and others.
Job Description
- To perform the duties of a Study Director for studies allocated by Management.
- Prepare and ensure that a study plan is conforming with the intentions of the study design agreed with the sponsor.
- Ensuring studies are performed to agreed timelines.
- To hold meetings with all key staff before study start ensuring all concerned are conversant with all aspects of the study.
- Monitor the status of study and ensure that all data are fully documented.
- To review all data to ensure its accurate and represent the actual observations.
- To ensure that the study is compliant with Good Laboratory Practice.
- To communicate with the Sponsor and Project Management as required with regard to problem areas which may affect completion date or content of the study.
- To prepare draft and final reports ensuring the report is concisely and accurately written, reflects the raw data and includes all relevant information. Archive all study related data in a timely manner after study completion as per SOPs.
Qualifications
- Master's degree in Zoology/ecotoxicology/ecology or related field), preferably with PhD.
- Experience in conduct of GLP ecotoxicological studies including study design and data analysis, for at least 5 years.
- expertise in a specific area of ecotoxicology or risk assessment is beneficial. Additionally, any certifications in research compliance, environmental safety, or toxicology are advantageous.
Additional Information
- Understanding of the regulatory requirements and the scientific methods adopted in Ecotoxicology testing.
- Skills related to analytical and problem-solving.
- Skills related to communication in English both written and verbal.
- Good understanding in statistical tools, software and data analysis.
- Skilled data interpretation and report writing experience.
- Working knowledge of software like MS Word, Excel, powerpoint and general IT skills.
