TCS Hiring for Clinical Operations- eTMF professionals for Mumbai/ Pune location
24 May, 2022
Role: Clinical Operations
Experience: 1 to 6 years
Location : Mumbai/Pune
- Ensure the TMF documents are filed and finalized to meet the required timelines as per study plan and document any deviations if any.
- Keep the TMF inspection ready and in alignment with the study agreed strategy and applicable milestones.
- Generate the TMF completeness metrics, track performance and liaison with relevant stakeholders for closure of actions if any
- Serve as point of contact for the study teams for TMF matters and liaise with TMF Subject Matter Experts (SMEs) and process owners to help their understanding of requirements and associated solutions.
- Conduct analysis and identification of business problems/opportunities that may arise and support the implementation of high quality solutions.
- Ensure the timelines of all the deliverables are met, keeping quality as a priority.
- Understand all aspects of the eTMF system and associated tools.
- Conduct regular teleconference with the client study teams and management and communicate related issues
- Good knowledge of Record management, DIA RM, clinical research, ICH GCP principles and regulatory requirements
- Good interpersonal, verbal and written communication skills
- Effective presentation skills, reports in excel and Story boards
- Experience in Client interactions and effective organization and time management skills
Interested candidates can share their CV to firstname.lastname@example.org