Vishalraj Saxena
Hyderabad
Summary
To secure a challenging position that leverages my extensive expertise and skills in clinical trial budget and contract negotiation. I aim to contribute significantly to an innovative organization's success by applying my in-depth knowledge and experience to drive operational efficiencies and financial optimization. My goal is to foster organizational growth while simultaneously pursuing opportunities for continuous professional development in the dynamic field of clinical research management.
Overview
9
9
years of professional experience
9
9
years of post-secondary education
2
2
Certifications
Work History
STUDY GRANTS ANALYST II
Parexel International Pvt Ltd.
11.2021 - Current
- Customizing country specific budget in accordance with protocol and parallelly coordinating with sponsors on site escalations
- Strategy management in GrantManager analyses and Grantplan FMV tools
- Develop and implement standardized QC procedures, resulting in reduction in budget errors and increase in review efficiency
- Conduct regular audits of budget processes and systems, identifying areas for improvement and implementing corrective actions
- Timely preparation of accurate and competitive Clinical Study grants (Phases I - IV for all clinical indications) via proficient usage of any Clinical Study Pricing Tool that PAREXEL is required to use to support our client's needs
- Liaison with internal stakeholders and sponsors to address budget-related queries and provide guidance on quality control best practices
- Ensure that all Clinical Study grant information is performed in full compliance with Fair Market Value (FMV) principles and the Physician Payments Sunshine Act
- Collaborate to prepare competitive budget concepts for Pre-sales business Proposals in conjunction with other members of the Proposal team while remaining compliant with the Request for Proposal (RFP) and PAREXEL internal policies
- Spearhead contract negotiations and budget development for several global trials, across diverse therapeutic areas including oncology, neurology, and rare diseases
- Subject Matter Expert and Lead on the creation, revision, escalation, and approval process of Clinical Study grants for awarded Projects with the assigned Site Contracts Leader and Study Project Leader and Project Director, as appropriate
- Participation in strategy sessions and budget reviews when requested to develop win themes, identify, and assess competitor’s benchmarks and discuss client needs
- Display good knowledge sharing capabilities, share lessons learned and new scenarios with the team
- Deliver and maintain client-focused Grants analysis to measure performance and proactively identify issues for resolution
- Study Grant Tool Vendor Management – Contact, expectation management, KPI’s, Governance Meeting agenda and conduct, reduced downtimes and ensuring business continuity
- Grants estimates delivery of respective portfolio of client partners and ensuring alignment to delivery of commitments, within the agreed expectations, including alignment to operational processes.
STUDY GRANT ANALYST I
Parexel International Pvt Ltd.
12.2018 - 11.2021
- Timely preparation of accurate and competitive Clinical Study grants (Phases I - IV for all clinical indications) via proficient usage of any Clinical Study Pricing Tool that PAREXEL is required to use to support our client's needs
- The default, currently licensed tool in this regard is GrantPlan and Grant Manager
- Augmented clinical expertise to define & validate specifications and expectations regarding Grants build and scenario planning
- Collaborate to prepare competitive budget concepts for Pre-sales business Proposals in conjunction with other members of the Proposal team while remaining compliant with the Request for Proposal (RFP) and PAREXEL internal policies
- Subject Matter Expert and Lead on the creation, revision, escalation, and approval process of Clinical Study grants for awarded Projects with the assigned Site Contracts Leader and Study Project Leader and Project Director, as appropriate
- Preparation of additional Post Award Clinical Study grant analyses for the assigned Site Contracts Leader and Study Project Leader and Project Director, as appropriate
- Participation in strategy sessions and budget reviews when requested to develop win themes, identify, and assess competitor’s benchmarks and discuss client needs
- Ensure that all Clinical Study grant information is performed in full compliance with Fair Market Value (FMV) principles and the Physician Payments Sunshine Act
- Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc)
- Display good knowledge sharing capabilities, share lessons learned and new scenarios with the team
- Deliver and maintain client-focused Grants analysis to measure performance and proactively identify issues for resolution
- Support & build departmental or functional training plans, content & delivery
- Study Grant Tool Vendor Management – Contact, expectation management, KPI’s, Governance Meeting agenda and conduct, reduced downtimes and ensuring business continuity
- Grants estimates delivery of respective portfolio of client partners and ensuring alignment to delivery of commitments, within the agreed expectations, including alignment to operational processes.
JUNIOR RESEARCH ANALYST
Excelra Knowledge Solutions (GVK Informatics)
02.2016 - 12.2018
- Gathering and recording clinical trial related data from external sources (PUBMED, EMBASE, COCHRANE, and Clinicaltrials.gov etc.) in specified format
- Support clinical trials for clients by providing meticulous data management
- Design and maintain databases, queries, reports, and data-analysis tools
- Interpret, synthesize, and present technical information to CRO management and pharmaceutical clients
- Encapsulation of clinical trial outcomes data collected and consolidated valuable information from published medical literature in a controlled and standardized fashion that can be efficiently used to support meta-analysis-based modeling and simulation activities for key decision making at various phases of drug development
- Creating reliable high-quality data that can be readily used for analysis.
Education
Pharm. D Internship -
Aware Global Hospitals
Hyderabad, Telangana 01.2016 - 05.2017
Doctor of Pharmacy (Pharm. D) - undefined
Sree Dattha Institute of Pharmacy
Hyderabad, Telangana 01.2011 - 05.2016
Intermediate - undefined
Sri Chaitanya Junior College
Hyderabad, Telangana 01.2009 - 05.2011
Skills
Maintaining a working knowledge of, and ensuring compliance with, applicable ICH Guidelines, Good Clinical Practices, and Regulatory Agency requirements
Demonstrating a thorough understanding of terminologies, methods, regulations, and protocols relating to clinical trials
Possessing strong knowledge of legal and organizational policies, protocols, and safety measures pertaining to research activities
Familiarity with standard business and eClinical systems used in clinical research
Completion of training at Clini India institute in Pharmacovigilance, Medical Writing, Clinical Research, and Clinical Data Management
Certification
Stood at 2nd in Seminar presentation on “IS IODIZED SALT NECESSARY IN OUR DAILY LIFE” at G. Pulla Reddy College of Pharmacy, Mehdipatnam, Hyderabad.
Languages
English
Hindi
Telugu
Urdu
Disclaimer
I hereby declare that the above furnished information is correct to the best of my knowledge, and I bear the responsibility for the correctness of the above-mentioned particulars.
Timeline
STUDY GRANTS ANALYST II
Parexel International Pvt Ltd.
11.2021 - Current
STUDY GRANT ANALYST I
Parexel International Pvt Ltd.
12.2018 - 11.2021
JUNIOR RESEARCH ANALYST
Excelra Knowledge Solutions (GVK Informatics)
02.2016 - 12.2018
Pharm. D Internship -
Aware Global Hospitals
01.2016 - 05.2017
Doctor of Pharmacy (Pharm. D) - undefined
Sree Dattha Institute of Pharmacy
01.2011 - 05.2016
Intermediate - undefined
Sri Chaitanya Junior College
01.2009 - 05.2011
Stood at 2nd in Seminar presentation on “IS IODIZED SALT NECESSARY IN OUR DAILY LIFE” at G. Pulla Reddy College of Pharmacy, Mehdipatnam, Hyderabad.
Attended a National Conference on “LEUKEMIA AND ITS POSSIBLE TREATMENTS AND MODALITIES” at VELS University, Chennai
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