Skills

Professional Summary:
• Clinical Research Professional with 9 years of industry experience in the fields of clinical trials with academic trainings in clinical research and biotechnology.
• Thorough knowledge and experience on ICH GCP R2 (Barnet Certified), Health Canada, US FDA, schedule Y and other regulatory requirements.
• Commendable Leadership skills in clinical project management, vendor management and team management with multi-tasking capabilities.
• Experienced in regulatory and IRB submissions, site feasibility, investigator meetings, kick-off meetings, audits/inspections, site selection visits, site initiation, on-site monitoring visits, site management through remote monitoring, site close out visits and data base lock.
• Experienced in usage and navigation of electronic database captures (eCRF), electronic trial master files, clinical trial management system, share point, people soft and other tools and systems used under various organizations
• Effective project management through strategic planning and review enabling milestone achievements
• Expert knowledge and experience in Clinical monitoring
• Well-versed with Risk based approach and resolutions applying quality control and quality assurance
• Proficient in using Internet, Microsoft office tools and applications (word, excel, PPT)

AREAS OF EXPERTISE
• Leadership skills and team work
• Project and team management
• Strong analytical skills • Mentoring and training • Convincing oral and
written communications
• Task prioritization
• Conflict resolution
• System administration

Refrences

RELEVANT EXPERIENCE
Centralized Monitoring Lead
2016-2019
IQVIA Mumbai, India
• Trained new employees and project team on operational requirements and project related work instructions
to support team efficiency
• Management of projects from kick of meetings to regulatory submissions till closeout phase in coordination
with project managers and other cross-functional leads ensuring milestones are achieved meeting the
timelines.
• Development of clinical study documents, protocol, eCRF guidelines, clinical operational plans, monitoring
plans and work instructions.
• Conducted regular project health checks ensuring completion, accuracy, resolving discrepancies by
preparing corrective and preventive action plans to ensure audit readiness
• Coordinated with internal departments to maximize operational efficiency across production and
administrative areas
• Organized and prioritized project tasks, optimizing team workflows and resources to handle dynamic
demands
• Integrated process improvements to increase overall workflow
• Global resource management of central monitors, project assistants, CRAs and CTAs for assigned projects
• Supervised team of 5-8 members cultivating productive atmosphere

Senior Central Monitor 2014-2016
IQVIA Bangalore, India
• Managed site by regular health checks and data analysis providing central support for site management.
• Ensured timely inflow of quality data through strong interpersonal communication skills with investigator
sites and CRAs.
• eTMF health check and document management.
• Proactive leadership in developing innovative work instructions and data analysis increasing productivity.
• Promoted to leadership position in recognition of strong work ethic and demonstrated ability to provide exceptional customer service.

Clinical Research Associate 2012-2014
SIRO ClinPharm Mumbai, India
• Managed and lead multiple projects with multiple sites with effective planning skills that lead to completion
of monitoring visits and visit report submissions ahead of timelines, leading to recognitions and awards for
conducting maximum monitoring visits without any deviations to monitoring visit plans.
• Conducted site feasibility, regulatory and IRB submissions, site qualification and selection visits, site
initiation visits, on-site monitoring visits and site close out visits meeting set milestones for assigned
projects.
• Reviewed clinical study documents (ICF, protocol, paper CRF, eCRF, site documents) on regular intervals to
ensure site’s compliance with ICH GCP, Protocol, IRB and other regulatory requirements.
• Organized and presented in Investigators Meetings, kick-off meetings, trained sites regularly to avoid major
protocol deviations or violations and minimize audit risks.
• Proactive data check for quality

Time and Spatial Flexiblity

Toronto, Canada

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