Regulatory Documents Assistant (India)



responsabilities

• Participates in the development of the TMF structure.
• Participates in the development of the electronic TMF (eTMF) Management Plan.
• Files or imports documents in the TMF.
• Performs record review of essential documents for accuracy and quality in the TMF.
• Assigns metadata and maintains trackers for the TMF.
• Sets up the conduct of eTMF quality reviews, performs, and addresses quality reviewfindings.
• Collaborates with the Project Assistant to define project scope and to develop the list ofexpected documents in the TMF.
• Works with the study team to resolve issues with the TMF.
• Receives and reviews regulatory documents from investigative sites for accuracy andcompliance with company SOPs and regulations.
• May assist project managers and coordinators with the creation and maintenance oftracking tools and study material.
• May assist with preparing shipments of study supplies to clinical sites.
• May serve as in-house contact to support Clinical Research Associates (CRAs).
• Participates in various administrative tasks as required to accomplish the goals of theprojects and the needs of the project teams
  

• College degree;
• Knowledge of clinical trial operations;
• Experience in clinical research in the biotechnology, pharmaceutical, and/or CRO industry;
• English (intermediate); French (Asset).
• Computer skills including proficiency in the use of Microsoft Word and Excel;
• Ability to organize own work and prioritize different assignments;
• Attention to detail and accuracy in work;
• Respect established timelines, expectations, priorities, and objectives;
• Versatile and comfortable in a multitasking environment
  

The work environment

• Flexible work schedule
• Permanent full-time position
• Company benefits package
• Ongoing learning and development
  

About Indero

Indero only accepts applicants who can legally work in India.