Vivek Kumar Email & Phone Number

Bengaluru, Karnataka, India

Leading the development of the company’s short- and long-term strategyCreating and implementing the company or organization’s vision and missionEvaluating the work of other executive leaders within the company, including directors, vice presidents, and presidentsMaintaining awareness of the competitive market landscape, expansion opportunities, industry developments, etc.Ensuring that the company maintains high social responsibility wherever it does businessAssessing risks to the company and ensuring they are monitored and minimizedSetting strategic goals and making sure they are measurable and describable

Bengaluru, Karnataka, India

• Ensure quality, speed, value and compliance throughout the Customer Information Materials Lifecycle• Coordinating the projects with project manager and the team• Creating project, tasks, assigning roles, maintaining procurement details using project management software • Convert text to columns in a worksheet• Work on VeevavaultPromoMats Application and Wrike• Advocate for each brand’s unique character, and ensure tactic quality and readiness for the promotional materialapproval process• Ensure quality, speed, value and compliance throughout the Customer Information Materials Lifecycle• Work with brands/Multi Channel Engagement (MCE) to understand needs, goals and objectives for insourced tactics and define outcomes• Add value when attending critical brand or MCE planning meetings with agency to ensure tactics are able to meet marketers’ expectations and timelines Troubleshoot barriers and provide solutions to deliver insourced projects on time• Identify ways to continuously improve processes by exploring opportunities to reduce costs and by documenting the rationale behind tactic decisions.• Actively participate in deviation investigations, and contribute to continuous improvement efforts as role dictates• Bring accurate and compliant insourced marketing tactics to market quickly, efficiently and on schedule • Develop detailed timelines/chronologies for insourced tactics• Manage and track timelines for insourced tactics and key milestones• Collaborate with Marketing Integration Associate (MIA) to schedule reviewers of insourced tactics Check work thoroughly between document approval system handoffs for insourced tactics(e.g., changes by IT, Creative Services, or proofreading are made before uploading)• Partner with MIA on promotional material approval process• Lead annual claims review/assessment• Support the MIA and marketer during the label change process and resulting actions

Bengaluru, Karnataka, India

• Act as an SME for the file management process & all RIM Global department initiatives• Work on VeevavaultPromoMats Application• Steering quality check of the clinical documents that are part of regulatory submission that include protocol, clinical study report, clinical trial registry summary, clinical summary of safety and clinical summary of efficacy• 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• Review Protocols to ensure database feasibility • Develop/build, review, and maintain a clinical database and supporting specifications documentation • Develop/build, document and perform validation of database structure, data capture screens, code lists, edit checks, reports and other functions in EDC (e.g. User Acceptance Testing) • Develop data transfer agreements and specifications with various vendors • Write, review and maintain eCRF completion guidelines, data management plan (DMP), data validation plan (DVP, e.g. edit checks), and other DM related documentation • Perform all aspects of DM process as related to processing and QC of the data • Manage reconciliation with any external data (e.g. SAE, lab) • Monitor study status (e.g. enrollment, CRFs, etc.) and provide status reports to the team • Clean data for study close out and perform all database lock procedures • Mentor junior level staff on database management tasks and processes

Pune

• Maintaining tracker records of the employee on a daily basis• Generating different reports on the basis of trackers on CITRIX.• Reconciliation and data validation through MYSQL , JAVA and Excel• Troubleshooting users technical issue (Tickets) which they raise on I-Man application• Attributing in the mapping of the documents, TMF entry, DCC mail box and QC of documents before submitting them to Quality Analyst Team• Updating MIS, QC report, Tally work and submitting completed work daily• Working on various activities like split/combine, execution, QC of bulk loaded documents, MIS & deletion activity• Reporting any issues (behavioral/performance) immediately to Team Leader• Developed complex SQL queries, using various joins and sub-queries Steering quality check of the clinical documents that are part of regulatory submission that include protocol, clinical study report, clinical trial registry summary, clinical summary of safety and clinical summary of efficacy• 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. • Write, review and maintain eCRF completion guidelines, data management plan (DMP), data validation plan (DVP, e.g. edit checks), and other DM related documentation • Perform all aspects of DM process as related to processing and QC of the data • Manage reconciliation with any external data (e.g. SAE, lab) • Monitor study status (e.g. enrollment, CRFs, etc.) and provide status reports to the team • Clean data for study close out and perform all database lock procedures • Mentor junior level staff on database management tasks and processes

Bengaluru, Karnataka, India

• Identifying/selecting an investigator who will be responsible for the conduct of the trial at the trial site.• Liaising with doctors/consultants or investigators on conducting the trial.• Setting up the trial sites, which includes ensuring each centre has the trial materials, including the trial drug often known as the investigational medicinal product. Training the study staff in standard operating procedure for the clinical trials as per applicable regulatory requirements.• Verify that investigator and investigator’s team are adequately trained and comply with the protocol.• Verify that IRB/IEC operates and complies as per GCP, SOP and applicable regulatory requirements.• Monitoring the trial throughout specified duration involving monitoring visit to the trial sites.• Source data verification• Informed consent form review, case report form review, investigational drug accountability, and adverse event review.• Ensuring all unused trial supplies are accounted for.• Writing visit reports, filing and collecting trial documentation and reports.

Pune, Maharashtra, India

• Identifying/selecting an investigator who will be responsible for the conduct of the trial at the trial site.• Liaising with doctors/consultants or investigators on conducting the trial.• Setting up the trial sites, which includes ensuring each centre has the trial materials, including the trial drug often known as the investigational medicinal product. Training the study staff in standard operating procedure for the clinical trials as per applicable regulatory requirements.• Verify that investigator and investigator’s team are adequately trained and comply with the protocol.• Verify that IRB/IEC operates and complies as per GCP, SOP and applicable regulatory requirements.• Monitoring the trial throughout specified duration involving monitoring visit to the trial sites.• Source data verification• Informed consent form review, case report form review, investigational drug accountability, and adverse event review.• Ensuring all unused trial supplies are accounted for.• Writing visit reports, filing and collecting trial documentation and reports.

Pune, Maharashtra, India

• Identifying/selecting an investigator who will be responsible for the conduct of the trial at the trial site.• Liaising with doctors/consultants or investigators on conducting the trial.• Setting up the trial sites, which includes ensuring each centre has the trial materials, including the trial drug often known as the investigational medicinal product. Training the study staff in standard operating procedure for the clinical trials as per applicable regulatory requirements.• Verify that investigator and investigator’s team are adequately trained and comply with the protocol.• Verify that IRB/IEC operates and complies as per GCP, SOP and applicable regulatory requirements.• Monitoring the trial throughout specified duration involving monitoring visit to the trial sites.• Source data verification• Informed consent form review, case report form review, investigational drug accountability, and adverse event review.• Ensuring all unused trial supplies are accounted for.• Writing visit reports, filing and collecting trial documentation and reports.

Bengaluru, Karnataka, India

• Maintain database of Rotarians• Data Validation and QC Check

P.G Diploma, Bioinformatics

B.Sc, Microbiology, General

10+2, Pcb

Education record