Sagar Kedar

About Sagar Kedar

Provide project related assistance for assigned complex project(s), sites and project teams. Ensure all work is conducted in accordance with SOPs, policies and practices, good clinical practices and applicable regulatory requirements and meets quality and timeline metrics Perform complex processes and tasks that eventually result in high quality deliverables that are completed according to service level agreements (SLAs) and within project timelines. Establish and maintain effective project/ site communications Create and maintain relevant project documents, Metrics. Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information Participate in document management (creation, review, maintenance, storage, as applicable) Review the documents before they are uploaded to repository in Review QC. Working as TMF Specialist and for File review. Follow-up with project team for Closing Action items.Handling of following Documents:o Clinical documents (Product specific, Site specific, Study specific) CTMS.o Safety documents: SUSAR, PSUR, CSR, SAE reporting forms, End point reporting, safety trackers.o Subject Specific: Case Report Form, Subject Diaries, Source documents etc.o Regulatory: Regulatory submission checklist, internal and external link for Clinical study report, publishing and formatting the documents checking orientation, split and combine documents as per submission, update tracker, Verification of all submission ids, Ensure the documents are correctly categorised in repository.o Knowledge about Clinical data Management: Start-up, Conduct- Query management, Discrepancy management. Learnt about Inform system during learning course of clinical research.

Experience

1. Etmf Specialist

   Fortrea

   Aug 2018 — Present · Bengaluru, IN

   Conduct imaging/scanning and train on imaging/scanning processes• Provide reference services to internal clients in accordance to SOPs and by maintaining accurate charge-out systems.• Sort and classify coded material for filing. Create files according to established classification system.• Maintain log and enter metadata in database to track status and facilitate accurate retrieval of information.• Coordinate work flow through assignment of tasks and establishment of procedures.• File, maintain and process reports, collections, and validations.• Maintain logs and indexes to provide status of information and assist in the collection of data for preparation of monthly metric reports.• Assist in the training of new team members on departmental procedures. perform Review QC of indexed documents as per standard operating procedures.

Education

• Paranjape School ,Nagpur

  Msc microbiology, Microbiology and Immunology

  2009 — 2011

• laxminarayan institute of technology ,IGNOU

  post graduate diploma in food saftey and quality management, Food Science and Technology

  2012 — 2013

• Advanced Diploma in Clinical Research,Clini India Bangalore.

  Associate’s Degree, Clinical research

  2014 — 2015

• Nagpur University

  Bachelor of Science (BS), Microbiology, General

  1987 — 2001

Skills

• Pcr
• Biopharmaceuticals
• Biotechnology
• Downstream Processing
• Lifesciences
• Microbiology
• Ich-Gcp
• Molecular Biology
• Cell Culture
• Biochemistry
• Dna
• Elisa
• Chromatography
• Fermentation
• Hplc
• Radioimmunoassay
• Cell