Chandrakant Naik

Act as an SME for the file management process & all RIM Global department initiatives
Provide support & mentor/training to coworkers within RIM
Serve as TMF contact for documentation to Project team, cross functional departments to ensure high quality TMF deliverables are met on time.
Follow processes for set up, maintenance, and support for assigned TMF projects.
Monitor TMF throughout the study duration, identify and record quality problems, suggest, initiate, recommend or provide solutions as appropriate.

Report TMF metrics trending and analysis as appropriate with resolution plans to proactively identify & avoid future issues
Facilitate collecting, processing and disposition of various project-related records for paper & electronic documents to sponsor
Follow applicable SOP’s to ensure completeness & accuracy of TMF
Prepare/present TMF related information at internal meetings in a Globally consistent format
Provide support & involvement with internal quality or audit process’s as relevant
Accountable for delivery of assigned TMF activities in accordance with project requirements & SLA’s
Manage documentation associated with assigned clinical trials
Follow records management tasks, policies, and procedures
Conduct review documents with compliance to Quintiles or customer file plans and SOPs
SME on all designated Sponsor-specific TMF requirements (e.g. file format, process, export/shipping requirements)
Collaborates on TMF Health for assigned sponsor trial reports TMF health findings at required frequency
Alert Project team and TMF Quality PM to any potential TMF Health issues
Provide regular updates on performance to SLAs
Act as a trainer/Mentor to provide the training and guidance related to process.

Worked on platforms like ELVIS, Wingspan tool.

TMF importer

• Performed QC and Importing of the essential /clinical documents in repository center with respect to the filing location through eTMF tool.
• Conduct review documents with compliance to GCP and SOPs.
• Act as trainer/Mentor to provide the training and guidance related to process.
• Met month-end reporting objectives and deadlines.
• Participated in special projects to increase productivity and make meaningful impact on company and mission.
• Performed reconciliations to drive accuracy and validity of financial information.
• Performed quality assurance checks on transactions and account actions to assess compliance with GCP regulations.

Document Analyst

• Performed technical quality check of clinical regulatory submission ready documents in central repository using Docheck tool and ISI adobe tool.
• Documents reviewed and checked e.g.: Protocol, Clinical study report, Narratives, protocol synopsis, ICF, DSUR listings,
• Aided the medical writers to edit regulatory documents with respect to the submission regulatory.
• QC of Standalone and Published documents ready to regulatory submission according to their required sections, Novartis standards format, Doctype, eCTD naming convention, PDF properties, Document life cycle,
• Published documents: Clinical study report, PSUR, DSUR,
• Standalone documents: Protocol, IB, ICF, Clinical overview, Patient narrative, Risk Management Plan, Synopsis
• Worked on Acrobat ISI tool box for creating Bookmarks, Hyperlinks, TOC, Version change, Add and remove pages in PDF format.

ACROBAT ISI Tool box

· Creating Bookmarks

· Creating Hyperlinks

· Creating TOC

Clinical Data Management-

• DCF Drafting
• DCF Verification
• DCF Entry
• CRF electronic data entry
• CRF electronic data verification
• Generate data queries based on validation checks and omissions identified during data entry
• Maintain the integrity of data, data system, project requiring data harvest, ensuring timely, relevant, accurate and consistent information use.
• Accountable for delivery of assigned TMF activities in accordance with project requirements and SLA's.
• Collaborated with team to define business requirements for organizational processes, achieve productivity standards, and adhere to accuracy standards.
• Performed quality assurance checks on transactions and account actions to assess compliance with state and federal regulations.
• Identified and resolved process issues to drive optimal workflow and business growth.
• Partnered with cross-functional teams to conduct thorough discovery and due diligence on existing processes.