Clinical Trial Operations and Affairs Manager

KAJAL R DESAI, MPH

*************@*****.*** +1-201-***-**** linkedin.com/kajaldesaimph

Slack, Problem-solving, Project management, CRM, decision-making, problem-solving, Good Clinical Practice, Communication skills, Attention to detail, Operations, Planning, Cross-functional, Project manager, organizational skills, team player, process improvement, performance management, Monday.com, technical support,

Quality Assurance, Cross-functional,

Problem-solving, Effective

Communication, Interpersonal skills,

coaching, mentoring, database, change

management, transformation, process

improvement, process optimization, risk

management, detail-oriented, decision-

making, agile, PMP, Excel, Word,

Smartsheet, Relationship management,

Presentation skills, problem-solving,

contractual obligations, delegations,

independent travel, diverse groups,

clinical trials, Pharmaceutical research,

cross- functional, innovative thinking,

innovative mindset, problem-solving,

analytical thinking, business strategy

Objective_Results-trial with execution, KOLs driven and ensuring Clinical _regulatory Affairs __adherence __compliance, and Operations _to FDA, _and stakeholder HIPAA, Manager IRB and _with engagement. GCP _7+ years regulations Adept _of experience at _to __leading _support in cross-clinical _clinical functional __research, _trial success. teams, _specializing collaborating in __clinical Experience Synchron Clinical · · · · · Momentis Led commercial Managed Developed Oversaw Built execution Affairs and Surgical: study maintained IRB clinical and expansion. and of management, Operations clinical contract Surgical research relationships trial processes Manager Robot strategy studies, monitoring, Technologies with and for including Investigators, US study CRF and development, protocols pilot international and strategic validation in alignment protocol clinical clinical studies, training studies. with development regulatory supporting and site partners, requirements. relationships. regulatory and approvals KOLs. Dec Fort 2021 and Lauderdale, Brooklyn, - Dec 2022 NY FL Clinical · · · FirstThought Research Led Collaborated Provided clinical Research Associate scientific trial and Manager execution, strengthened leadership for in a relationships study robotic protocol surgical with development, system, research ensuring and data development compliance analysis, and partners, with publication FDA global and strategies. GCP stakeholders guidelines. Sept Mar 2020 2021- and New KOLs. – Sept Mar York, 2021 2021 NY

· · Designed Conducted research data-driven methodologies analysis to and support developed decision-evidence making strategies for preclinical to support and clinical new medical study designs. innovations. NYU Biostatistical Consulting New York, NY

Senior Data Analyst Consultant Jan 2020 – May 2020

· · Conducted healthcare Developed and data analysis strategies a detailed study to framework analyses capture and patient and on focused sleep interpret management apnea on success critical and approaches. PAP variables. factors adherence, for underrepresented uncovering impactful students, data leveraging insights that survey informed tools in Tableau Memorial Sloan Kettering Cancer Center New York, NY Research Study Assistant – Clinical Research Coordinator Feb 2018 – June 2019

· · · Led Managed Compiled site operations IRB and submissions, analyzed for multiple study site data feasibility oncology for research clinical assessments, presentations trials, and ensuring investigator and compliance regulatory engagement with reporting. GCP, for FDA, study and start-ICH up guidelines. and execution. Education New Master Rutgers Bachelor York of University of Public University Arts and Health - Science New (MPH)Brunswick (BS), Biostatistics, Public Health and Psychology 2017 2012 – – 2020 2016 Skills

· Clinical site selection, Trial Management: contract negotiation, Study start-patient up, trial recruitment, execution, protocol regulatory adherence, compliance trial and execution. IRB/FDA submissions, monitoring,

· Core management, Competencies: real world Clinical evidence & preclinical and data research analysis leadership, robotics & medical device development, global study

· · Project management, Technical Management: Proficiencies: budget oversight. Risk CTMS/mitigation, eTMF, EPIC, stakeholder EDC, Veeva engagement, Vault, Monday.cross-functional com, STATA, team R, SPSS, leadership, Tableau, vendor/Microsoft CRO Office

· · Soft Languages: Skills: Effective English (communication, Native), Gujarati problem-(Native), solving, Spanish leadership, (Intermediate)negotiation,, Hindi (Intermediate)process improvement, Italian (Elementary)

· Certifications: GCP certified (renewed Oct 2024)

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