Management Analyst Refining
Resume:
Yashaswini B N
#*, ********** ***** ****** ******,
1st Cross Cottonpet Main Road,
Bangalore - 560053
Mobile: +91-973*******
Email: **************@*****.***
OVERVIEW:
To take up a challenging career, which would enable me to utilize my skills to the fullest potential by carrying out the best management practices and thereby ensure to deliver the organization goals along with the personal growth.
SUMMARY:
eTMF Analyst/Lead with 6 years of experience in Project Support Services with responsibilities including of complete e-TMF management of a project and providing support to the Clients. PROFESSIONAL EXPERIENCE:
1. Working as a Records Management Analyst 1 at IQVIA, Bangalore, Karnataka since May 2015 till date.
Responsibilities -
Function as team leader for records management projects. Ensure project deadlines, commitments, and goals are met by monitoring team’s daily outputs.
Coordinate the retrieval of records requested by users and prepare closed studies for transfer to clients.
Train team members on records management tasks, policies, and procedures.
Monitor filing accuracy and compliance to IQVIA or customer file plans and SOPs.
Monitor and assist in the preparation of closed studies for transfer to clients per agreed due dates.
Interface with departments to support retrieval projects and ensure information needs are met. Serve as primary contact for clients.
Recommend changes or revisions to records retention schedules. Maintain accurate indices and databases to control inventory.
Collect data and assist in the preparation of statistical reports for management on all phases of record management operations.
Design and administer records management systems
Identify the document based on the class such as Site/Country/Core and assign the metadata to the respective document with reference to PSMT/QSMT /SSMT as per project specific guidelines.
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Ensure the documents are placed in correct artifact, delete document if found for incorrect pagination/poor image quality/ improper rotation/incomplete document/insufficient language description for non-English document.
To perform all duties associated with the Batch registration & complete the process end to end with tasks that eventually result in high quality deliverables that are completed according to service level agreements (SLAs) and within project timelines
Adhere to the PSMT for eTMF document processing, ensuring that it is referenced every time a document is processed.
To perform 100% Pre QC. If applicable, perform remediation of documents.
Action on Priority requests received from Mailbox regarding audits/ inspections, study close outs & other study specific milestones.
Proactively address issues and escalations conveyed by project team and suggest process improvements.
To perform document Deletion accurately by initiating the ELVIS DIA Delete Workflow and inform Document Submitter accordingly
Process documents from the TMF Drop Area in a sequential order on a basis of First in First out.
Develop an understanding of the role which records management plays in managing TMF documents for sponsors at quintiles.
Involve in query resolution process of fellow team members.
Participate in process improvement/Contribution to Organizational Initiatives that lead to better PDQ
Imbibe Quality & Risk Management techniques for all project deliverables. 2. Worked as Process Associate at Infocon International Ltd, Bangalore, Karnataka since August 2014 till April 2015
Responsibilities -
● Work for Scopus database. It is a bibliographic database containing abstracts and citations for academic scientific journals, articles. It is the world’s largest abstracts and citations database of peer reviewed literature.
● Access Scopus and connect to database
● Entering terms for author search, document search, affiliation search
● Refining the search results by using various filtration options EDUCATION:
Master of Science - Biotechnology
MS Ramaiah College of Arts, Science and Commerce, 2014 Page 3 of 4
Bachelor of Science - Microbiology
BMS College for Women, 2012
ACHIVEMENTS:
Received thrice WWD (Work Worth Doing)
Shout Out, Bravo, Applause and Ovation award, appreciation for team work and working on priority tasks with maintaining the quality of work.
KEY SKILLS:
● TMF
● CRO
● ICH-GCP
● Document Management
● Pharmaceutical Industry
● SOPs
● Team work
● Documentation
● Quality Control
● Records Management
● Mentoring
● TMF Quality Oversight
CERTIFICATION:
Clinical Research Training: Good Clinical Practices (BARNET GCP) Training Course. PERSONAL DETAILS:
Date of Birth 07 Dec 1991
Age 29
Gender Female
Nationality Indian
Marital status Single
Linguistic Abilities English, Hindi, Kannada
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DECLARATION:
I hereby declare that the above-mentioned information is correct and up to my knowledge and I bear the responsibility for the correctness of the above mentioned particulars. Place: Bangalore Yashaswini B N
Date:
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