RAKSHATHA P.C.

Centralised Study Specialist * (eTMF Specialist)

CONTACT:

admuqk@r.postjobfree.com

+91-990**-*****

“Prithvi” House,

Sampaje High School road,

Kallugundi, Sullia Taluk D.K.

Karnataka-India 574239

EDUCATION:

M.Sc. Biotechnology

St.Aloysius College

(Autonomous), Mangalore

University (2009-2011)

Diploma in Bioinformatics

St.Aloysius College Mangalore

Mangalore University (2007)

ACHIEVEMENTS:

• Received twice WWD (Work

Worth Doing) Triumph award for

quality of work by processing

<5000 documents in one quarter

with <95% quality.

• Received appreciation for team

work and working on priority

tasks with maintaining the

quality of work.

• Received appreciation from

Sponsor for quality of work and

received “People Excellence”

award from PM and LM.

KEY SKILLS:

• TMF

• ICH-GCP

• VEEVA Vault

• Inspection Readiness

• Document Management

• CTMS

• Team work

• Quality Control

• Records Management

• Mentoring

• Microsoft Office

CAREER OBJECTIVE:

To be in an integral part of a result-oriented company that seeks an ambitious, dynamic and career conscious person where acquired skills and education will be utilized towards continuous growth and advancement.

SUMMARY:

As a dependable and dedicated individual, I have depth knowledge of clinical trial documentation and the process in which a clinical trial TMF is managed and handled, from TMF-set-up to TMF finalization for reconciliation to the Sponsor. I have attained my knowledge and experience through working on all phases of a clinical trial and have vast experience in all aspect of the TMF, from managing customers, coordinating and completing file reviews, QC and document processing, supporting all functional leads and through TMF oversight activities. I currently work within TMF Master File Delivery Center as Centralised Study Specialist 1 for a world leading CRO. While working within this industry I have developed my leadership skills, improved my capability to work as part of a dynamic team, managed workloads and people relations and met deadline and objectives. I am a highly ambitious person who seeks to rapidly grow my potential and to further develop and progress through a company.

PROFESSIONAL EXPERIENCE:

COVANCE Clinical Developmental Service, Bengaluru, Karnataka-India Centralised Study Specialist 1/ March 2020 - Present

• Manage the activities associated with ensuring file reviews are being conducted as per sponsor requirements. They are being properly documented, actions followed-up, and evidence of such activities are visible to the customer.

• Perform quality control on all documents received per In-line QC checklist and other reference documents.

• Demonstrate understanding on document type, properties and indexing requirements.

• Ensure overall TMF quality by checking document completeness, indexing and scanning accuracy.

• Process documents in the TMF system within specified timelines, based on document criticality / priority.

• Communicate document inquires with responsible users as needed.

• Liaise with document owners, TMF study owners and/or other end users to resolve document related discrepancies and issues.

• Communicate and escalate issues to the Lead TMF Document Specialist and TMF Quality Project Manager

• Ensure that documents are transferred correctly within the TMF system per SOP and TMF related reference documents.

RAKSHATHA P.C.

Centralised Study Specialist 1 (eTMF Specialist)

IQVIA (IMS Health and Quintiles together) - Human Data Science Bengaluru, Karnataka-India

TMF Quality Project Manager / August 2015-February 2020

• Manage the activities associated with ensuring file reviews are being conducted as per sponsor requirements. They are being properly documented, actions followed-up, and evidence of such activities are visible to the customer.

• Support project teams with the use of eTMF to ensure compliance of TMF documents (file location, naming conventions, reporting, file review)

• Ensure that teams are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by records management.

• Evaluating the issues identified in TMF filing activities and processes from a quality management standpoint and proposes operational solutions when applicable.

• Implementing, executing and improving TMF QC process, performing logic checks of trial documents with a moderate level of complexity. Molecular Connections Pvt. Ltd. Bengalore, Karnataka-India Scientific Analyst / February 2012 – November 2015

• Utilized bioinformatics tools, methods, and databases such as Genbank, Pubmed, Mesh, Gene, MGI, UNIPROT, NEXTPROT

• Conducted research to collect and assemble data for databases. I was responsible for development of relational databases for collecting data.

• Maintained the data integrity during extraction, manipulation, processing, analysis and storage.

• Carried out research article indexing with ontology enhancements and semantic tagging, for scientific research articles.

• Semantic tagging using automatic, manual and semi-automatic approaches.

• Handled Quality Assurance checking for all the curated articles by the team.

• Managed the Quality Assurance testing and daily performance MIS of all employees in the project.

CERTIFICATION:

Clinical Research Training: Good

Clinical Practices (BARNET GCP)

Training Course, 2018.

PER'SONAL DETAILS:

Gender :Female

Age :33

Nationality :India

Marital status : Married

DOB : 25-June-1988

LINGUISTIC ABILITIES:

English, kannada, Hindi

HOBBIES:

Reading Books, Drawing,

Painting, Calligraphy, Arts and

Crafts

DECLARATION:

I hereby declare that, the above information is true and correct to the best of my knowledge. Place: Bangalore-India

D Date: (Rakshatha P.C.)

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