Highlights:

Skills:TMF, Trial Master File, Veeva Vault

Lead eTMF Specialist 04/2016 - current
Covance Inc., Mumbai, Maharashtra India
Industry: Clinical Research
Veeva vault
? Handling the highest number of 60 studies (Projects) on global level as a Start-up, Inspection Readiness & Document Management lead, to set-up new studies in veeva vault as per the client requirements. Managing the count of uploads into eTMF and provide the reports to Project Managers. ? To built the study eTMF in veeva system, manage to ensure the addition of sites and to ensure the start-up of the study is moving smoothly. ? Preparing the EDL for each milestones and ensure the timely periodic reviews of eTMF. To ensure eTMF periodic reviews should be initiated on each milestone to the designated fucntional leads and they complete the workflows within the stipulated timelines. ? Responsible for meeting daily, weekly, monthly contractual service levels (Productivity, TAT and Quality) ? Responsible for meeting daily, weekly, monthly internal metrics (AHT, Utilisation, Internal Quality, Retention) ? Responsible for workload balancing and work assignments ? Assess capacity shortages and requirement for overtime ? Review capacity support requests from other teams and support as required ? To provide the trainings on eTMF during the internal core study team meetings. Coaching team members to effectively resolve all issues. ? Ensures individuals and the team meet their performance objectives ? Act as a liaison with the client for any process updates, additional scope, training ? Responsible for coaching and performance improvement of trainees, BQ performers ? Responsible for ensuring SOPs and Training Materials are up-to-date ? Review capacity requirements on an ongoing basis and initiate hiring, redeployment requests as required; Additional focus required for Open Enrollment capacity planning ? During OE assess client requests to support high volume spikes and provide support if possible ? To manage the accesses of study teams in veeva. To upload the documents and initiate the various workflows with-in the sytem such as Deletion workflow, Approval workflow, Authoring, e-signatures workflows and ensure that it gets completed on time and as per compliance. ? During migration of eTMF systems, was in the pilot migration team which was very well appreciated by the global eTMF team. ? Conduct the global team meetings to provide any updates. Any department and system related queries needs to be resolved.--
Sr. Clinical Process Associate 11/2014 - 04/2016
Quintiles Research Pvt. Ltd., Bangalore, Karnataka India
Industry: Clinical Research
? Ensure effective security, storage, and retrieval of all proprietary and client information in accordance with established procedures. Includes usage of scanning equipment, Clients tool
? To process, QC and import the documents belonging to the site as well as study level into client tool ? To conduct Internal Quality Control (IQC) procedures to maintain the quality of team members. ? To collate & maintain daily, weekly and monthly reports for production & quality of data processed by the team members and report to the functional managers. ? 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. ? Conduct imaging/scanning processes and train imaging/scanning processes ? File, maintain and process reports, collections, and validations where applicable. ? 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.--
Clinical Trial Assistant 04/2012 - 11/2012
SP Software Technologies Pvt Ltd, Pune, Maharashtra India
Industry: Clinical Research
Clinical Operations
? To provide general administrative support to the Clinical Operations Department and assistance to Project Manager(s) and Project Director(s). ? To assist the Clinical Operations teams in completion of all required tasks to meet departmental and project goals. ? To support the Clinical Operations teams with ongoing conduct of studies ? To be familiar with the roles of the Clinical Research Associates (CRA) including site visits. ? To assist project teams with study specific documentation and guidelines as appropriate. ? To set up, organize and maintain clinical study documentation (e.g. Main Study Files, CRFs, etc.) including preparation for internal/external audits, final reconciliation and archival. ? To process Data Collection Forms i.e. log in, tracking, quality control as appropriate for the study. ? To assist in quality control audits of clinical study documentation (e.g CRF Files, Monitoring Files, etc.) ? To assist project teams with trial progress tracking by updating the Clinical Trial Management systems. ? To copy and route incoming correspondence, internal documentation, CRFs, etc., as appropriat--
Data Control Centre-Associate 12/2012 - 10/2014
Syntel Ltd., Pune, Maharashtra India
Industry: Clinical Research
Data Control Centre
? Working with the US and India Data Control Centre team to download the document jobpacks from the onsite drives and handling the regular updates. ? To process, QC and import the SAE reports, Regulatory submissions, Study level and site documents recieved directly from onsite through mailbox into first doc. ? Management of clinical data into the trackers of the various jobpacks downloaded and tracker entry. ? To process, QC and import the documents belonging to the site as well as study level into first doc. ? Proof reading the documents so as to deliver an error free final product to be uploaded in repository. ? Review the documents for legibility and completeness. ? Sampling QC of the documents prior to importing into FD. ? Taking update sessions for the onsite updates and provide floor support to the new employees. ? To run the First Doc validation procedures, ? Co-ordinating with the teams with regards to recent updates. ? Split or combine the documents as per the onsite requirements--
CDM - Trainee 11/2011 - 04/2012
SP Software Technologies Pvt Ltd, Pune, Maharashtra India
Industry: Clinical Research
Clinical Data Management
? Designing and review of study specific Case Report Form (CRF) ? Designing of CRF in oracle clinical for all the phases of clinical trials, CRF Annotations ? Performing Effective and consistent Validation Checks to get 100% Valid and Clean Data. ? Preparation of Data cleaning Specifications. ? CRF log in and Tracking ? Data entry ? Running Batch validation for clinical trials--
Regulatory Affairs Assistant 05/2010 - 07/2011
Emcure Pharmaceuticals, Pune, Maharashtra India
Industry: Healthcare - Clinical Research
Regulatory Affairs, NDA, IND licensing
? To ensure the appropriate licensing, marketing and legal compliance of pharmaceutical and Medicinal Products. ? To prepare submissions of licenses variations and renewals to strict deadlines. ? To archive the various licenses acquired from the regulatory agencies. ? Collecting, collating and evaluating scientific data that has been researched by colleagues.--

College of Pharmacy, Ahmednagar Jun/2005 - Jun/2010
Ahmednagar, Maharashtra, India
Degree: Bachelor's Degree
Major:Pharmacy
B. Pharmacy

Yogesh Suryawanshi Resume CV, Resume