Aboli Kulkarni Email & Phone Number

Born and Brought up in India, an expat to Canada as a Permanent Resident; I am a Clinical Trials Professional with 8 years of experience and a strong regulatory foundation (Master’s in Pharmacy with Regulatory Affairs Specialization). Developed expertise in clinical trials submissions to regulatory authorities (Health Canada, MHRA, Bulgarian Drug Agency, CTIS applications) as well as to central Institutional Review Boards (Advarra and WCG (Canada)), Global Site Management, Site Budgets, Vendor Management, Review Labels and Subject-Facing Materials as per Health Canada and US FDA guidelines, preparing clinical trial documents – ICFs, Protocols, Reviewing documents in eTMF and, Updating CTMS, NARA, and company database.I believe that I have developed the capability to identify and manage risks involved in conducting clinical trials and I hold strong interpersonal skills to enable cross functional activities to resolve escalations and achieve business goals in accordance with compliance guidelines and allocated budget. My education curriculum and professional experience has helped me to learn prioritization of work, time management, ability to work in a fast-paced environment, eye for details as well as effective verbal and written communication with internal and external stakeholders. I also hold experience in literature review, pharmaceutical product launch activities, conducting scientific trainings sessions of the field force, round table conferences with KOLs and, executing cadaver workshops, training sessions for junior healthcare fraternity.

Listed skills include Microsoft Office, English, Teamwork, Photoshop, and 13 others.