Clinical Trial Manager

12/2014 – 6/2020

• Lead for the Clinical Operations and project management for global studies.
• Experienced in therapeutic areas like Oncology, Neurology, Ophthalmology, Vaccination, Hematology and Dermatology.
• Previous proven success in working in a CRO environment
• Responsible for successful execution of projects in line with project specifications: timelines, budget, quality and resources - Key tasks include leading the project team, finalization of project plans including training plans, tracking of project metrics and KPIs
• Overall responsibility for the performance and progress of each functional area (Data Management, Pharmacovigilance, Clinical Trial supplies ).
• Working closely with project teams to determine appropriate milestones with in timelines.
• Project financial control and liaison with finance, contracts and billing team to ensure adherence to contract, budget and invoicing requirements
• Management of third-party vendors: strategic partners, central laboratories, central imaging, randomization systems, drug depots, training vendors
• Experience in clinical trial design and global drug development process.
• Handling and mentoring the reporting team as per the protocol and study requirements.
• Experienced in studies with ePRO and other health data technologies used for recruitment of the patients

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