Ashna Aby

I am eager to become an integral part of a prestigious and forward-thinking organization, where I can apply my extensive expertise and knowledge to enhance client satisfaction, ultimately contributing to the mutual advancement of both the company and myself.

• Team Management
• Daily Operations: Ensure daily functioning of offshore team.
• Forecasting and projections of headcount, utilization of resources, allocation of resources to studies.
• E TMF Specialist skilled in Project Management, ICH GCP and Clinical Trials, support and collaborate with stakeholders for TMF related activities.
• Does eTMF Quality Control and metadata check for maintaining 100% clean and complete TMF.
• Expertise knowledge in QC of clinical trial documents including various approvals and submissions, monitoring reports and CRFs, SOPs and protocols, subject recruitment materials, training certificates etc.
• Perform documentation and clinical data capturing in IQVIA's eTMF product on behalf of end clients.
• Participates in assessment and management of trial documents by rectifying and proofing data to maintain quality standards.
• Submit monthly reports commenting on deviations from Business Plan and intended actions to align performance with objectives.
• Ensure punctual delivery of reports and daily synchronization of ETMF/ ETMS Veeva.
• Monitor and assess documents to identify potential irregular patterns.
• Act as a mentor/buddy and provide training to junior teammates using expertise knowledge on clinical trial activities.
• Recording and distributing meeting minutes within onshore/offshore team.
• Communicate client specific decisions and changes to current process or guidelines.
• Lead and attend weekly-biweekly calls with onshore team to discuss issues/concerns.
• Communicate administrative concerns to manager.
• Update status and collate data for WSR as required in accordance to expectations to onshore counterparts weekly.
• Deliver the output within agreed SLAs from resources.
• Work independently with minimal direction and be team oriented with ability to work in an onshore/offshore model.
• Focused, detail oriented.
• Follow "first time right" approach.
• Have flexible approach to adjust working hours to support deliverables and to coordinate with the team.

Worked for clients Otsuka, Biogen and Taiho

As a driven and diligent Pharm D graduate, I bring a robust three-year background in Clinical Research. My unwavering commitment to excellence propels me to continually challenge myself and strive for the pinnacle of performance. With a keen focus on enhancing global patient safety and fostering organizational growth, I am poised to make a significant impact in my future endeavors.