Job Role : Associate
Skills Needed
- e-TMF/ Document Specialist
Office timings
General shift (9 am to 6.30 pm) until further notice but candidate needs to fine with 24/7 rotational shift and night shift
Minimum Qualification
Bachelor’s/ Master’s Degree in Life Sciences, Pharma, Clinical Research and/or a Scientific Degree
Responsibilities
- Understanding of clinical documents Trial Master File (TMF)- like, Safety, Submission and R&D related documents
- Ensure the understanding of Clinical Trials in general
- Ensure the identified properties and features from clinical documents are correct
- Have understanding of artifacts and attributes associated with documents
- Conduct Quality Checks involved
Experience
- Clinical document management system
- Clinical research monitoring, pharmaceutical, CRO or healthcare industry
- Knowledge of ICH GCP, 21 CFR part 11 regulations
- Working knowledge of clinical essential documents, including trial master file and clinical submission documents
Location
Kolkata (candidate who is out of transport boundary will have to relocate to Kolkata vicinity as per our transport team guidelines)
