Seasoned Clinical Research Professional with 15 years of experience working in clinical research domain with 7 years' experience as a Global Clinical Trial Manager and with 3 years of experience as regional team lead. Seeking an opprtunity to work with an organization with whom I can share my extensive experience in a longterm career capacity. A Manager who leads by example, with positive attitude and versatile skill set, always in pursuit of continuous learning opportunities. Diligent and motivated to improve process, build effective teams, and bring success to the organization.
Serve as primary point-of-contact (POC) for the clinical aspects of designated projects, including smaller or single service projects.
• Responsible for developing successful cross-functional relationships with internal and external stakeholders.
• Responsible for planning, scheduling, and implementing the clinical aspects of projects in line with contract and budget including implementation of protocol and amendments, protocol deviation prevention, tracking and reporting, IP management, and timely investigator payments.
• Responsible for driving enrollment as per contracted timelines.
• Perform oversight of visit report reviews and approvals, including site issue escalation and resolution, direct review/approval of site visit reports and interact with the Central Visit Report Approvers, as appropriate.
Responsible for coordinating, managing, and mentoring the clinical project team to ensure their high performance and productivity ( e.g. days on site for CRA s ), optimal utilization, continuous development, minimal turnover, and that all necessary project training is provided and docum ented.
• Actively involved in clinical risk planni ng and assessment, developing mitigation strategies and associated action plans, and issue escalation and resolution.
• Responsible for the development and maintenance of operational plans for clinical deliverables including CRF completion guideline, Monitoring Plan, Recruitment Plan, Clinical Training Plan, annotated trip report, etc.
Participate in the hiring interview process when applicable.
• Participate in business development activities including bid defense meetings and provide input to the clinical strategy.
As Lead responsible for handling Phase I centers.
Communicationwithclientsonregularbasistoprovide project updates. Report review & finalization, Study set up in CTMS. LiaisingwithContractsdepartments&ensuringtimely payments are made from the clients. Responsible for client specific training requirements for the CRAs involved in these studies
Involvedduringstudystartup,monitoring &studyclose out phases
Monitorthesitesinordertoensurethatstudiesarecarried outaccordingtothestudyprotocol andinaccordancewith ICONSOPs/WPs,applicableregulationsand the principlesof ICHGCP.
Performsourcedocumentverificationaspermonitoring plan andensurethatsourcedocuments&othertrial recordsare accurate,complete,keptup-to-date&maintainedaccording toapplicableSOP'stoavoidincompleterecords.
We have won Clinical Research Team of the Year for this project in 2019.
Through application of extensive therapeutic and operational experience, successfully executed a full-service 9901 patient (Cardiovascular Outcomes Trial) CVOT, delivering enrollment and Database Lock (DBL) significantly ahead of plan and achieving a >99% vital status ascertainment, despite early retention challenges. Creative and proactive retention management, innovative final visit planning, and collaborative CRO/Sponsor communication enabled quality delivery of DBL 9 months earlier than planned.Proactive management and flawless execution resulted in the early announcement of the first T2DM medicine to demonstrate superiority in MACE reduction in a trial including a majority of participants without established CV disease.
Key Team achievements:
● Enrollment achieved one year early
● Exceptional Patient Retention
● >99% Vital Status (VS) Ascertainment
● Trust built through continuity and demonstrated delivery
● 38 day LPV to DBL
● Database Lock (DBL) nine months early
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