Dr. Pranali Bhatti
Ahmedabad,India
Summary
Highly experienced with 10+ years of combined experience in managing the project and leading the clinical research team.
Expertise in project planning, risk management, stakeholder engagement, budgeting, and resource allocation.
Project Management Specialist with experience working with teams to accomplish short- and long-term project goals. Managed budgets and monitored project costs. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.
Skilled Lead Clinical Research Associate with a proven track record of success in managing complex clinical trials with a keen eye for detail, I have implemented innovative strategies to identify and mitigate risks, resulting in successful study outcomes.
Effectively led cross-functional teams to ensure studies are conducted in compliance with regulatory requirements and timelines are met. Professional
Overview
10
10
years of professional experience
8
8
years of post-secondary education
Work history
Global Project Manager, Study Delivery Lead
Glaxosmithkline
Mumbai, Maharashtra
2021.09 - Current
- Lead the cross-functional project teams to ensure successful completion of projects within scope, budget, and timeline.
- Develop project plans, including timelines, budgets, and resource allocation, and ensuring adherence to project management methodologies.
- Coordinate project activities with internal and external stakeholders, including clinical research organizations, regulatory bodies, and contract manufacturing organizations.
- Communicate project progress, risks, and issues to senior management and stakeholders, and developing mitigation strategies as needed.
- Monitor project performance and making necessary adjustments to ensure successful project delivery.
- Ensure compliance with regulatory requirements, industry standards, and best practices in project management.
- Lead project meetings, preparing meeting agendas, and documenting meeting minutes.
Global Project Manager
Novo Nordisk Pharmaceuticals
Bengaluru, Karnataka
2019.06 - 2021.09
- Managed end-to-end project execution, presentation and prepared timelines, and budgets to ensure that projects are completed on time and within budget.
- Led the cross-functional teams to achieve project goals, including assigning tasks, monitoring progress, and providing feedback.
- Identified potential project risks and developing contingency plans to mitigate them.
- Ensured that all project activities are in compliance with regulatory requirements, such as FDA guidelines.
- Evaluated project processes and outcomes to identify areas for improvement and implementing changes to increase project efficiency and effectiveness.
- Ensured that all projects have a well-documented project plan according to the project requirements, Stakeholder/matrix team management, Risks and issue management.
Clinical Process Specialist 2
IQVIA
Ahmedabad, Gujarat
2018.04 - 2019.05
- Identified areas for improvement in clinical processes and developing and implementing strategies to optimize workflow, increase efficiency, and reduce costs.
- Participated in quality improvement initiatives to ensure that clinical processes are consistent with quality standards and best practices.
- Maintained documentation related to clinical processes, including policies and procedures, project plans, and audit reports.
- Assisted in the development of iSite Pack template, KDPMP and other tools/templates for DTE studies.
- Closely worked with site monitor and CL during study execution phase with respect to recruitment and compliance to clinical operation plan.
- Performed on-going risk assessment through data trending and analytics and proposes potential mitigating actions in a timely fashion & supports CRA in management of quality issues.
- Reviewed the RM Dashboard and resolve any items that need attention (i.e., Resource Assignment Errors, Queried Requests, and Inactive Resources Still Assigned).
Sr. Clinical Process Specialist
IQVIA
Bengaluru, Karnataka
2015.10 - 2018.03
- Led cross-functional teams in analysing technological changes to understand operational impact.
- Oversaw processes and plans to evaluate impact of potential changes, aiding management to prepare for range of scenarios.
- Performed research to understand departmental and organisational needs, using findings to create tailored solutions.
- Conducted training classes, held personal meetings and led special workshops to improve employee performance.
- Assessed and mitigated potential risk of novel solutions through cost-benefit analysis.
Senior Clinical Research Associate
Lambda Therapeutic Research Ltd.
Ahmedabad, Gujarat
2014.04 - 2015.09
- Led and managed a team of CRAs to ensure timely and quality delivery of clinical trial projects.
- Ensured compliance with regulatory requirements, study protocols, and Good Clinical Practice (GCP) guidelines.
- Developed and reviewed study documents including protocols, informed consent forms, case report forms, and monitoring plans.
- Conducted risk assessments and implement risk mitigation strategies.
- Performed query resolution process with site, CRA and DM, Update CTMS for key trial country and site event dates, Provide input to prepare monitoring plan, eCRF designing & review.
- Assisted in preparation & Submission of Regulatory documents and vendor contracts.
- Trained and mentored junior CRAs and other clinical research staff.
- Performed site monitoring visits, ensuring that data is collected and reported accurately and in a timely manner.
Clinical Research Associate
Intas Pharmaceuticals Ltd.
Ahmedabad, Gujarat
2013.06 - 2014.03
- Drove study recruitment and compliance by developing and maintaining strong relationships with site personnel.
- Maintained site documentation, performing Case Report Forms (CRF) reviews, source document verification and query resolutions.
- Evaluated quality and integrity of study site practices, promptly escalating issues to mangers for resolution.
- Enhanced predictability, liaising with sites to adapt, drive and track subject recruitment plan according to project needs.
- Monitored site practices to guarantee compliance with protocols.
- Consistently met quality targets by monitoring clinical deliverables and promptly addressing quality issues.
- Detected protocol deviations, using appropriate channels to report and escalate incidents.
Education
Doctor of Philosophy - Biosciences
Saurashtra University
Rajkot, Gujarat 2004.05 - 2008.06
Master of Science - Plant Science
Saurashtra University
Rajkot, Gujarat 2002.11 - 2004.05
Bachelor of Science - Microbiology
Virani Science College
Rajkot, Gujarat 2000.05 - 2002.11
Skills
- Strategic planning
- Strategic research
- Operational support
- Financial risk analysis
- Project Management
- Project Planning
- Business Management
- Research & Development
- Continuous Improvement
- Clinical Research Associate
- Clinical Trial Management System (CTMS)
- Clinical Trials
- Budgeting
- Auditing
- Technical Documentation
- FDA , GCP
- Risk Management
- Quality Management
Languages
English
Advanced
Hindi
Fluent
Gujarati
Native
Timeline
Global Project Manager, Study Delivery Lead
Glaxosmithkline
2021.09 - Current
Global Project Manager
Novo Nordisk Pharmaceuticals
2019.06 - 2021.09
Clinical Process Specialist 2
IQVIA
2018.04 - 2019.05
Sr. Clinical Process Specialist
IQVIA
2015.10 - 2018.03
Senior Clinical Research Associate
Lambda Therapeutic Research Ltd.
2014.04 - 2015.09
Clinical Research Associate
Intas Pharmaceuticals Ltd.
2013.06 - 2014.03
Doctor of Philosophy - Biosciences
Saurashtra University
2004.05 - 2008.06
Master of Science - Plant Science
Saurashtra University
2002.11 - 2004.05
Bachelor of Science - Microbiology
Virani Science College
2000.05 - 2002.11