Rakhi C. S
Data Operation Associate
- Role
- Data Operation Associate at IQVIA
- Location
- Kottayam, IN
- LinkedIn followers
- 500 followers
About Rakhi C. S
Experienced Data Operations associate in eTMF team skilled in applying metadata, conducting file reviews and perform indexing and QC of Clinical research documents in eTMF. Strong attention to detail and independent thinking to meet client requirements and project timelines. Proficient in indexing of migrated clinical research documents. Extensive clinical trial background including informed consent, data analysis and record management. Expertise in study documentation in accordance with SOP, work instructions, ICH-GCP Guidelines and study specific TMF plans. Coordinate with Clinical document team leads for project related queries. Seven months experience as a Clinical research coordinator having skills include maintaining the source documents, CRF\'s, Investigator Site File and other study related documents according to ICH-GCP guideline, Completing the eCRF, Maintenance of IP according to the specific temperature. Preparing for site qualification visits, initiation visits, monitoring visits and site close out visits, submitting all study related documents to EC, coordinating with the local labs, central labs, assistance in Safety Reporting within the required timelines, assistance in patient selection and recruitment. Three years worked as a Project coordinator (DST project) in an NGO to design, write and execute project plans. Responsible for overall supervision of project activities, submit narrative and financial reports monthly.
Experience
Data Operation Associate
Feb 2022 — Present · Kochi, IN
Delivery capabilities (Indexing, Quality check, Meeting SLAs) Raise issues/ queries- send it to SPOC (via email) and follow up for resolution, Engagement/ training (Compliance with all mandatory trainings- departmental and role specific), Attend weekly/ biweekly calls with team, Administrative concerns communication with manager
Education
Mar Augusthinose College, Ramapuram Bazar P.O., Kottayam-686 576
Bachelor's degree, Biotechnology
Vellore Institute of Technology
M.Sc, Applied microbiology
2015 — 2017
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