Payal Deshpande
Campbell
Summary
7 years of project management experience in the Medical Device industry Highly motivated individual with excitement for new challenges and passion to learn. Strong individual contributor as well as a good team player
Overview
18
18
years of professional experience
Work History
Senior Clinical Evaluation Project Manager
Abbott Vascular
Santa Clara
01.2021 - Current
- Provides scientific expertise throughout the development and implementation of clinical evaluations.
- Manages clinical evaluation plans and reports (CEP, CER), writes Periodic Safety Update Reports (PSURs), Summary of Safety and Clinical Performance (SSCP), Canada Summary Reports (CASR), protocol amendments and clinical study project timelines.
- Identify appropriate scope for state-of-the-art analyses, establish safety and performance objectives and acceptance criteria.
- Provide strategic guidance on regulatory requirements pertaining to clinical data and clinical evaluation for new product development and legacy devices.
- Responsible for drafting regulatory responses for questions raised by the Notified body.
- Interacts with various study support groups cross-functional teams in order to assist in clinical strategy, the development of plans, reports and project deliverables.
- Collaborate with internal cross-functional stakeholders (like R&D, Clinical R&D, Regulatory Affairs, Library Services, Product Performance Group, Quality Engineering, Clinical Affairs or Clinical Science, Risk Management, Clinical Project Management) and external CROs or Medical Writers, to conduct continuous clinical evaluation activities.
- Identify potential gaps or risks to existing data and work with stakeholders to assess options.
- Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process.
- Ensure compliance with regulatory standards, guidelines, directives and regulations, and internal procedures.
- Review clinical-related deliverables (post-market clinical follow up plans and reports, risk evaluation files, instructions for use, patient guides, etc.)
- Manage project schedules to ensure timely execution for submissions and annual updates.
- Conducts team meetings, drafting and sending routine correspondence (e.g., newsletters) and/or by presenting regular updates to senior staff.
Clinical Evaluation Project Manager
Abbott Vascular
Santa Clara
01.2019 - 12.2020
- Support EU MDR related activities and development of clinical evaluations plans and reports of vascular devices.
- Develop post-market hospital data collection plans, reports and product analysis report as per requirement.
- Request missing documents from the corresponding departments.
- Work closely with cross functional teams involved in international regulatory submissions.
- Review critical documents and reports for completeness and suitability for submission.
- Provide support to the manager for various other clinical documents.
Clinical Research Associate
Vibrant Genomics (Vibrant America)
San Carlos
09.2017 - 09.2018
- Develop protocols, case report forms and informed consent forms for diagnostic evaluation studies.
- Develop marketing material for the products and documents for FDA submission (510k).
- Collaborate with external stakeholders for study purposes.
- Interact effectively with members of the product development and with other lab personnel to plan product and diagnostic studies.
- Generate data & summarizing results in technical reports and scientific papers.
- Work with internal teams to obtain an in depth understanding of the product and the documentation requirements.
- Co-ordinate with external research labs for sample sourcing for clinical diagnostic studies.
Scientific Program Manager
GlaxoSmithKline Pharmaceuticals
Mumbai
01.2014 - 02.2015
- Plan & execute of Epidemiological (Epi) studies.
- Perform supervisory duties and serve as the chief communication contact between Principal Investigator, Investigator and GlaxoSmithKline Pharmaceuticals Ltd.
- Monitor finances of the study (sanctioned vs spent budget, vendor negotiations, record & track unseen expenditure).
- Collaborate with cross functional teams (legal, regulatory, marketing, finance) for study activities and project communications.
- Engage key opinion leaders (physicians, pathologists, healthcare professionals) for collaborations on various ongoing & upcoming epidemiological studies and evaluating emerging diseases.
- Document clinical adverse events & pregnancies. Also assist in follow ups and update the monthly pharmacovigilance tracker.
- Provide responses to safety requests for vaccines from the field (marketing team/ physicians).
- Conduct in house audits and inspections.
- Provide recent scientific information related to therapy area.
- Organize conferences.
Clinical Research Coordinator
GlaxoSmithKline Pharmaceuticals
Mumbai
08.2011 - 12.2013
- Coordinate the epidemiology study in assigned cities with Investigator, Local and Central Laboratory.
- Responsible for the efficiency of workflow in study activities.
- Update study files for investigators, sponsors & for audit purposes.
- Support the preparation & maintenance of Adverse events documents.
- Organize regular meetings for project communications & project update.
- Prepare literature / case study research to identify disease burden.
- Prepare newsletters, medical affairs slide decks, investigators brochure, author write-ups and articles on vaccine preventable diseases & other related documents for in-house research and study purposes.
Research Fellow
P. D. Hinduja National Hospital & MRC
Mumbai
07.2007 - 07.2011
- Screening of NDM-1 organisms in health-checkup executives.
- Patient characteristics and treatment outcomes associated with complicated community acquired Intra-Abdominal Infections (IAI) in which Extended Spectrum Beta-Lactamase (ESBL) –producing Enterobacteriaceae are isolated (SMART study).
- Early Detection of Invasive Fungal Infections in immunocompromised patients (Thesis topic).
- Compromising all treatment options- the new endemic: New Delhi Metallo-1 (NDM-1) in Enterobacteriaceae in a tertiary care center, India.
- To monitor, globally and longitudinally the in vitro susceptibility of bacterial isolates from intra-abdominal infected sites to Ertapenem and other antimicrobials. (SMART -Study & Monitoring of Antimicrobial Resistance Trends).
- Hospital Acquired Pneumonia (HAP) including Ventilator Associated Pneumonia (VAP) in adults: Etiology clinical outcome and antibiotic susceptibility pattern.
- ESBL (Extended Spectrum of Beta Lactamases) Time Study Case.
Education
International Course in Applied Epidemiology -
Rollins School of Public Health, Emory University
Atlanta, GA01.2014
Master of Science - Applied Biology – Thesis
University of Mumbai
India01.2010
Bachelor of Science - Microbiology
University of Mumbai
India01.2006
Skills
- Clinical Strategy
- Project management
- Multi-tasking
- Collaboration with external vendors and internal cross functional teams
- Cost and time management
- Critical thinking and resolution
- Organizational skills
Research Publications
- High Frequency of Extractable Nuclear Autoantibodies in Wheat-Related Disorders, Yang Y, Krishna K, Deshpande P, et al., Biomarker Insights, 2018, 13, 1177271918782893
- Alliance for surveillance of invasive pneumococcal disease in India – The ASIP Study: Design and methodology, Anand Manoharan, Jyotsana Singh, Payal Deshpande. ASIP Study Group., Pediatric Infectious Disease, 2016, 8, 2, 58–63
- New Delhi Metallo-β Lactamase (NDM-1) in Enterobacteriaceae: Treatment options with Carbapenems Compromised, Payal Deshpande, Camilla Rodrigues, Anjali Shetty, Farhad Kapadia, Ashit Hedge, Rajeev Soman., Journal of Associations of Physicians of India, 2010, 58, 147-149
- New Delhi Metallo-1: Have carbapenems met their doom?, Payal Deshpande, Anjali Shetty, Farhad Kapadia, Ashit Hedge, Rajeev Soman, Camilla Rodrigues., Clinical Infectious Diseases, 2010, 51, 10, 1222
- Standardization of Fungal PCR for the early diagnosis of Invasive Fungal Infection, Payal Deshpande, Anjali Shetty, Ajita Mehta, Farhad Kapadia, Ashit Hedge, Rajeev Soman, Camilla Rodrigues., Indian Journal of Medical Microbiology, 2011, 29, 4, 406-410
- No NDM-1 carriage in healthy persons from Mumbai: reassuring for now, Payal Deshpande, Viral Vadwai, Anjali Shetty, Reeta Dalal, Rajeev Soman, Camilla Rodrigues., J Antimicrob Chemother, 2012, January 11
- Triple-disk assay for phenotypic detection of predominant carbapenemases, Preeti Pillai, Viral Vadwai, Payal Deshpande, Mehul Panchal, Anjali Shetty, Rajeev Soman, Camilla Rodrigues., Indian J Med Res, 2013, 138, December, 1025-1026
Timeline
Senior Clinical Evaluation Project Manager
Abbott Vascular
01.2021 - Current
Clinical Evaluation Project Manager
Abbott Vascular
01.2019 - 12.2020
Clinical Research Associate
Vibrant Genomics (Vibrant America)
09.2017 - 09.2018
Scientific Program Manager
GlaxoSmithKline Pharmaceuticals
01.2014 - 02.2015
Clinical Research Coordinator
GlaxoSmithKline Pharmaceuticals
08.2011 - 12.2013
Research Fellow
P. D. Hinduja National Hospital & MRC
07.2007 - 07.2011
International Course in Applied Epidemiology -
Rollins School of Public Health, Emory University
Master of Science - Applied Biology – Thesis
University of Mumbai
Bachelor of Science - Microbiology
University of Mumbai