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Vizeta Shriprakash Tiwari

****, * ****** *******, ***** York, Toronto, ON – M2N5X7, Canada

Phone - +1 – 437-***-****

PROFESSIONAL EXPERIENCE

14+ years of experience as passionate leader including skills of Line Management/Project Management/Change management driving end to end results and success to the project with appropriate results.

SENIOR CLINICAL MANAGER/ CLINICAL MANGER, Clinical Management PPD, Mumbai /New Delhi, India/ Canada - Homebased (Aug 2010 – present)

Communicating/Consulting with bidding teams (Commercial Analysts, Operations Leads and Strategy Analysts). Participating in bidding calls and consults bidding teams on the Risk Based Monitoring approach.

Participates in Business Defence meetings and presents the Risk Based Monitoring Approach to clients

Maintains own operational and financial metrics for the team

Discuss and explain the Client the details of the Risk Based Monitoring when requested ad hoc.

Requests the Synergy specifications which are necessary for the completion of the Risk Based Monitoring bidding tool. Performs the initial risk-assessment of the protocol.

Builds the monitoring strategy and develops SDV and remote sampling rates. Completing the Bidding tool in order to calculate average SDV and allocate appropriate number of onsite and remote IMVs to budget.

Participates in new initiatives and process improvement projects

Discusses with the Lead Strategy Analyst the Risk Based Monitoring section of the proposal text and provides the Risk Based Monitoring text language for companies’ commercial proposals to clients.

Presents the Risk Based Monitoring strategy to all interested parties (Business Development, Project Management and Commercial Finance).

Participates in Business Defence meetings and presents the Risk Based Monitoring Approach to clients.

Focusing on end results to be achieved, using metrics and key performance indicators to manage individual and team performance.

Leading the Clinical Management team for a country as required or contribute to initiatives that enhance Clinical Development/PPD business objectives.

Leading and/or participating in local and regional cross functional initiatives and process improvement projects.

Facilitating regulatory inspections/ audits along with Quality Assurance team.

Representing country/ region in global initiatives for process development & improvement.

Recruitment and selection of new clinical operations staff

Allocation of appropriately qualified/ experienced staff to projects

Mentorship, work direction and coaching of CRAs through activities such as accompanied field visits, file reviews and visit report reviews

Ensure all staff CVs, training records, job descriptions and experience profiles are complete and up to date

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Develop and deliver training on SOPs, WPDs, local requirements and any other subjects that impact on clinical operations

Maintain records of Accompanied Field Visits and certification of individuals monitoring proficiency and ensure required AFV frequency is achieved

Support activities of Project Managers (PMs) and Clinical Team Managers (CTMs) locally to optimize the operational running of projects at local level

Regulatory Compliance Reviewer, performing a final and independent quality control of Essential Documents required for start of a clinical trial in Asia Pacific.

Assist PM/ CTM with any set-up or troubleshooting activities as required

Conduct feasibility studies, provide input into bids and contribute to the procurement of new business where required

Conduct regular performance appraisals/ reviews with reporting staff

Facilitate professional development of staff through encouraging participation in professional meetings and career development programs

Identify and implement process improvements to local systems within the office

Maintain awareness of national legislation affecting clinical research, regulatory and local approval procedures and ensure country flag pages electronic system templates are up to date

Manage and conduct induction programmes for all new employees

Alert management to any serious quality issues that may arise, and request QA audits where necessary

Facilitate client and internal quality assurance audits as required

Promote use and familiarization of electronic SOPs and WPDs, ensure required training is performed before the effective date and train staff in conjunction with Clinical Operations training department

Ensure timesheets are accurate, coded correctly and entered/approved by monthly deadline

Working on RFPs as required and provide details for the save.

Involve in GMQ initiatives as a representative for the APAC region. Also involved in sponsor Franchise, a team created within PPD to ensure projects for particular key sponsors are handled efficiently. Responsibilities include:

Coordinate and attend meetings with the sponsor local representatives – both telecon and face to face meetings.

Interaction with CTMs to discuss project issues and support them as needed.

Attend internal team calls along with CTMs and CRAs to better understand project status and give inputs as needed.

Plan, develop and roll-out initiatives to streamline processes and improve quality. Regulatory Compliance Review (RCR) Coordinator for India Responsibilities include :

Allocate reviewers for studies in India

First point of contact for RCR related queries

Improve overall quality and streamline the review process CLINICAL SITE MANAGER

PPD, Mumbai India (Jan 2009 to Jul 2010)

Involved in line management for 6 -8 employees.

Mentorship, work direction and coaching of CRAs through activities such as accompanied field visit, file reviews and visit reports review.

Ensured all staff CVs, training records, job descriptions and experience profiles are complete and up to date.

Delivered trainings on SOPs, WPDs, local requirements and any other subjects that impact clinical operations

Maintained records of Accompanied Field Visit and certification on individuals monitoring proficiency and to ensure that the required AFV frequency is achieved. 3

Supported activities of Clinical Team Mangers locally to optimize the operational running of projects at local level.

Involved in recruitment and selection of new clinical operation staff.

Regulatory Compliance reviewer, performing a final and independent quality control of essential documents required for start of clinical trial on site.

Assisted CTM for any trouble shooting activities required.

Conducted regular performance review / appraisals with reporting staff.

Facilitated professional development of staff through encouraging participation in professional meetings and career development programs.

Alerted management of any serious quality issues that arose and requested QA audits where necessary.

Facilitated client audits as required.

Ensured timesheets are accurate, coded correctly and entered and approved within the monthly deadline.

Also Involved in sponsor Franchise, a team created within PPD to ensure projects for particular key sponsor are handled efficiently. Responsibilities include:

Coordinated and attended meetings with the sponsor local representatives – both telecon and face to face meetings

Interacted with CTMs to discuss project issues and support them as needed.

Attended internal team calls along with CTM and CRAs to better understand the project status and give inputs as needed.

Planned and developed roll –out initiatives to streamline on processes so as to improve on quality. Project responsibilities:

Was responsible for managing sites within geographical area specified, to meet contractual obligations and project guidance such as Monitoring Plan, DVM, SMMP etc.

Mentored new CRAs as directed by various Line Managers

Generated appropriate agenda and led in CRA team calls.

Generated tools & guidance for project activities with CTM support and direction e.g. MVR generation guidelines; project-specific SIV guidance.

Reviewed Monitoring Plan and possessed the ability to appraise documents received from Client. Worked closely with CTM with regards to attendance of Client Calls or Global Internal Management Calls to develop customer management and leadership skills.

Assisted with resource management and forecasting activities as supervised by CTM.

Was responsible for conducting report review and project specific report related training within CRA team. Contributed to overall management of MVRs and clinical deliverables-i.e. coordinated report reviewer activity within team in line with business needs.

Was responsible for reporting any identified or perceived risk and suggested strategies for contingency planning.

SENIOR CLINICAL RESEARCH ASSOCIATE

PPD, Mumbai, India (Jan 2008 – Dec 2008)

Performed all duties of a CRA as listed below, serving as the primary contact with individual investigative sites that conduct clinical research for PPD

Tracked enrollment status reports to ensure study stayed on track to meet enrollment goals

Tracked study-specific status reports to ensure all required information regarding site issues, deviations, and CRF status were kept current by the monitoring team

Conducted routine performance assessment visits for less experienced CRAs to ensure monitoring met PPD standards

Served as mentor/trainer for less experienced CRAs to assist with general and study-specific monitoring issues

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As an approved accompanier, conduct sign-off authorization visits for new CRAs on pre-study, initiation, interim and close-out visits

Provided direct support to the Clinical Team Manager by assisting with monitoring visit report review and other managerial tasks

Performed study-specific training with project team

Developed study-specific monitoring tools and forms for use by monitoring team to assist in efficient review of study data

Performed Serious Adverse Event reconciliation and worked with sponsor, study sites and CRAs to resolve discrepancies

Reviewed outstanding data reports and worked with CRAs to ensure data collection was met per contractual guidelines

Assisted sponsor, study sites, and CRAs with audit preparation/responses and quality issues CLINICAL RESEARCH ASSOCIATE

PPD, Mumbai, India (Oct 2006 – Dec 2007)

Attended sponsor calls to stay informed of current study status

Performed and coordinated assigned aspects of the clinical monitoring process in accordance with GCPs and global SOPs to assess the safety and efficacy of investigational products and/or medical devices.

Conducted site visits to determine protocol and regulatory compliance, and prepared required documentation

Developed collaborative relationships with investigative sites and client company personnel.

Clinical Research Associate on phase II global trial on HIV infected treatment naïve subjects with a treatment of subjects with 84 week extension period. Involved in performing Interim Monitoring visits at the site follow up with the coordinators, resolving DCFs and involved in 3 interim data base lock for the study. Line listing review and mentoring and trained new CRAs and PAs for the study. Coordinated and communicated with the SMO involved as appropriate for the study related updates.

Clinical Research Associate on phase II b, randomized, double-blind, placebo-controlled, dose and dose regimen-ranging study of the safety and efficacy of study drug in serologically-positive systemic lupus erythematosus patients with active disease and its extension study. Involved in site selections and interacting with investigators.

Clinical Research Associate on phase III global trial on atrial fibrillation. Involved in conducting feasibilities and site selection visits for the sites.

Clinical Research Associate on phase III global trial on Elective Hip replacement. Involved in conducting feasibilities and site selection visits for the sites

Performed interim monitoring visit for database lock for a phase III study to assess the safety, tolerability and efficacy of the study drug as an adjunct to concurrent anticonvulsant therapy for infants with refractory and partial-onset of seizures.

Clinical Research Associate on a phase II study for nonvalvular atrial fibrillation. Involved in site assessment visits and feasibility. Document management and tracking, EC submission and regulatory submissions.

Clinical Research Associate on phase III global trial on atrial fibrillation. Involved in all in-house activities like site follow ups, feasibility conduct, document management, ethics committee submissions.

Clinical Research Associate on multicentric phase IV global trial on hepatitis B virus. Involved in In- house activities for start up. Document management, EC submission to sites, document tracking and RCR compilation.

Clinical Research Associate on multicentric randomized, double blind Type 2 Diabetes Mellitus study Involved in feasibility study and was point of contact with Investigators CLINICAL RESEARCH ASSOCIATE

Clininvent Research Pvt. Ltd, Mumbai, India (Dec 2005 – Oct 2006) 5

Clinical Research Associate on multicentric phase III global chronic renal failure trial. Performed interim monitoring and site initiation visit. During this trial mentored 2 CRAs new to the team and took the lead in creating monitoring tools for the team. Performed in house CRF review and maintained the in house file for the study.

Clinical Research Associate on multicentric phase III cardiovascular and cerebrovascular disease trial. Performed Site Initiation and Interim Monitoring visit. Was involved in maintenance of in house files for the study.

Clinical Research Associate on multicentric phase III diabetes (Type II) trial. Involved in conduction of feasibility study and contacting investigators.

Clinical Research Associate on multicentric global phase III malaria trial. Involved in conduction of feasibility study and contacting investigators.

Clinical Research Associate on multicentric phase III febrile neutropenia and systemic fungal Infection trial. Involved in file maintenance and preparing presentations for IM. Also presented CRF completion guidelines and instructions for the study in the IM.

Clinical Research Associate on multicentric phase III asthma trial. Involved in-house review of the CRFs, maintained study files and CRF transmittal. For this trial performed secondary CRF review on 100% of the data and assisted in training CRAs on CRF guidelines. EDUCATION

M.Sc., Clinical Research, 2006

Dr. MGR University, Chennai, India

MBA, Marketing, 2007

GJU University, Hissar, India

B.S., Microbiology, 2004

University of Mumbai, Mumbai, India

PROFESSIONAL DEVELOPMENT

Lean Six Sigma Trained

Leadership trainings on Strategical Thinking, Decision Making, Employee Engagement, Coaching

International Conference on “India’s Emergence as Hub for Clinical Research”

National Conference on “Clinical research – Challenges & Opportunites in India” COMPUTER EXPERIENCE

Windows OS, MS Office, MS Outlook, Electronic Data Capture, CTMS, Organization’s electronic systems THERAPEUTIC EXPERIENCE

Infections/Parasitic Diseases: Malaria, Systemic fungal Infections, Chronic HBV infection, HIV Endocrine/Metabolic: Diabetes

Hematology: Febrile Neutropenia

Nervous System/Sense Organs: Infant Epilepsy

Circulatory: Cardiovascular Cerebrovascular Diseases, Venous Thrombosis Embolism, Non valvular Atrial Fibrillation

Respiratory: Asthma

Genitourinary: Chronic renal failure

Musculoskeletal: Prevention of VTE in patients undergoing Elective Hip replacement 6

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