Leenet Vinita
Upperhutt,Wellington
Summary
Dynamic professional with extensive experience at IQVIA, excelling in project coordination and strategic thinking. Proven track record in patient recruitment and compliance, successfully managing safety operations and enhancing quality systems. Adept at fostering team collaboration and delivering results, ensuring regulatory adherence while driving operational excellence.
Overview
17
17
years of professional experience
1
1
Certification
Work History
Administrative Officer/Clinical Study Coordinator
Lakeland clinical trials
Upper Hutt , Wellington
05.2024 - Current
- Compiled trial related documents into a master file as required by sponsor or regulatory agency.
- Monitored patient safety during clinical trials according to established guidelines.
- Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
- Maintained accurate up-to-date tracking logs for all aspects of clinical research activities including but not limited to adverse events, serious adverse events, concomitant medications, lab results .
- Developed and maintained accurate and timely study databases.
- Kept patient care protocols and clinical trial operations in compliance.
- Provided guidance on Good Clinical Practice regulations and other applicable regulatory standards.
- Monitored subject enrollment and tracked dropout details.
- Reviewed CRFs for completeness and accuracy before database entry.
- Organized investigator meetings; developed meeting agendas; created presentations; tracked action items from meetings; coordinated follow-up communications after meetings.
- Performed patient assessments, collected and analyzed data, and prepared reports.
- Educated participants on studies and anticipated outcomes.
- Conducted screening interviews to determine eligibility of possible subjects.
- Reviewed medical records for accuracy of source documentation prior to database lock.
- Collaborated closely with team members to achieve project objectives and meet deadlines.
- Provided support and guidance to colleagues to maintain a collaborative work environment.
- Managed time effectively to ensure tasks were completed on schedule and deadlines were met.
- Developed and implemented strategic recruitment plans to meet study objectives.
- Maintained records of participant information in database system.
Senior Manager, Operations Team, Pharmacovigilance
IQVIA
09.2021 - 10.2023
- Oversee medical devices and drug safety operations including all case management activities in both clinical and post marketing settings
- Contribute to a full range of pharmacovigilance (PV) activities for investigational product and marketed products, including cross functional operational activities, process improvement initiatives, quality systems, audits and inspections
- Manage relationships with safety vendors, business partners and functions as the first point of escalation in case of issues and take appropriate action
- Lead study start-up activities for safety operations including overseeing the set-up and implementation of safety systems and processes
- Partner with the PV case management lead and training Lead
- Collaborate with other departments for Service Level Agreement activities
- Collection and reporting of KPIs with staff, contracts and deliverables to senior management
- Contribute to department budgeting, forecasting and reviewing of invoices
- Manage safety audits and inspections; assume the role of SME, ensure inspection readiness by developing and contributing to quality management plans and a compliance program
- Oversee safety database related projects including system implementation, UAT, validation, configurations, and report generation
- Provide expert guidance on global regulations, and industry guidelines and their impact on Safety management processes and procedures
- Recruit, hire, mentor and manage direct reports, with responsibility for employee performance evaluations
Manager, Operations Team
IQVIA
06.2018 - 08.2021
- Managing Medical Device and Drug PV operations: Looking after overall Project compliance and training requirement
Associate Manager
IQVIA
10.2016 - 05.2018
- Led and managed a team of 20 PV specialists and senior specialists/team leads that handled hundreds of AE reports a week in global clinical safety & post marketing projects
- Tracked financial status of assigned projects and provided regular reports to senior management on status of projects and interactions with clients
- Established and maintained a thorough understanding of project protocol, budget and scope of work for assigned projects; set up and maintained project materials
- Handled AE/SAE reports from multiple CTs & PMS for submission to worldwide regulatory authorities according to applicable regulations and guidelines, standard operating procedures (SOPs), and project requirements
- SME on Product Quality Complaint, Complaint Vigilance reconciliation, Regulatory relevance determination and medication errors
Assistant Manager
IQVIA
10.2014 - 09.2016
- PV Subject Matter Expert
- Quality review
- Training and mentoring new joiners
- Case allocation
- Metrics management
- Acting Team Leader
Senior Operation Specialist
IQVIA
04.2013 - 10.2014
- Medical device case processing
- To Prepare & update Safety & Complaint Plan on a timely basis, Work allocation, tracking, & workflow management within the team, to participate in CRF and CSR review for safety related issues, to review and collaborate with client for regulatory/ ethics committee reports
Operation Specialist
IQVIA
09.2011 - 03.2013
- Medical device case processing
- Receive, triage, review, and process data from various sources on time, and meet quality standards
Drug Safety Associate 2
IQVIA
04.2010 - 09.2011
- Handling ICSR
- Registration/Initiation/Book-In
- Triage
- Causality assessment
- Narrative writing
- Inactivation/deletion SME
- Quality review of the spontaneous cases (serious and non-serious cases), clinical trial cases, literature cases, recall cases prior to reporting to the regulatory abiding the SOP's and timelines
Drug Safety Associate 1
IQVIA
09.2008 - 04.2010
- Handling ICSR
- Registration/Initiation/Book-In
- Triage
- Causality assessment
- Narrative writing
- Inactivation/deletion SME
Education
Master of Microbiology -
St Joseph's college
Bangalore, India01.2008
Bachelor of Science - Microbiology
St Joseph's College
Bangalore, India01.2006
Skills
- Strategic thinking
- Patient recruitment
- Project coordination
- Results orientation
- Attention to detail
- Multitasking
- Decision making
- Team collaboration
- Interpersonal skills
- Resource planning and scheduling
- Communication skills
Certification
- ICH GCP Certification
- Lean Practitioner MOOC
- Barnett Accreditation - Fundamentals GCP
- Barnett Certification: Good Clinical Practice for Clinical Trials
- Fundamental GCP Accreditation Exam
Accomplishments
- Several Impact Awards: Silver, Bronze
Affiliations
- Participated in a risk-based monitoring kickoff meeting for a new project held in Minnesota in May 2016.
- Participated in the Europe Investigators meeting held in Germany in December 2016
- Participated in the USA/Canada Investigators meeting held in Texas-Jan2017.
- Participated in a Risk based monitoring kick off meeting for new project held in BostonMar-2017.
- Participated in a Risk based monitoring kick off meeting for new study held in MinnesotaSep-2017.
- Participated in a Risk based planning for the completion of the Clinical Study Report and to deliver to the Regulatory Authority held in Miami- Jun-2018
Timeline
Administrative Officer/Clinical Study Coordinator
Lakeland clinical trials
05.2024 - Current
Senior Manager, Operations Team, Pharmacovigilance
IQVIA
09.2021 - 10.2023
Manager, Operations Team
IQVIA
06.2018 - 08.2021
Associate Manager
IQVIA
10.2016 - 05.2018
Assistant Manager
IQVIA
10.2014 - 09.2016
Senior Operation Specialist
IQVIA
04.2013 - 10.2014
Operation Specialist
IQVIA
09.2011 - 03.2013
Drug Safety Associate 2
IQVIA
04.2010 - 09.2011
Drug Safety Associate 1
IQVIA
09.2008 - 04.2010
Master of Microbiology -
St Joseph's college
Bachelor of Science - Microbiology
St Joseph's College
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