As a Clinical Project Manager, my role is pivotal in ensuring the successful planning, execution, and completion of clinical trials. I am responsible for overseeing the entire lifecycle of clinical projects, from protocol development to closeout activities. This includes coordinating and managing cross-functional teams, ensuring compliance with regulatory requirements, and maintaining a focus on patient safety and data integrity. I play a crucial role in budget management, resource allocation, and timeline adherence to meet project milestones effectively. My responsibilities also involve risk assessment and mitigation, as well as effective communication with internal and external stakeholders. Overall, as a Clinical Project Manager at Compass, I am dedicated to driving excellence in clinical trial execution and contributing to the advancement of healthcare and medical research.

Led the successful management of global Phase II and Phase III oncology trials, providing strategic leadership and guidance to CROs and clinical site management teams throughout the trial lifecycle, from inception to completion. Directed feasibility activities critical to trial planning and execution.
Served as the Regulatory Manager and Safety Manager for assigned clinical trials, ensuring adherence to regulatory requirements and prioritizing patient safety. Managed global investigational sites to guarantee protocol compliance and overall alignment with clinical objectives.

Pioneered the development of Clinical Department SOPs and study guidelines/plans, actively contributing to the creation of essential study documents such as Protocols, ICFs, and other study materials. Oversaw strict compliance with the Clinical Monitoring Plan, including conducting site visits, reviewing and finalizing visit reports, and promptly addressing Protocol deviations as necessary.

Dedicatedly trained CRAs and PMs in the implementation of study protocols and Clinical operations SOPs, fostering operational excellence. Stepped in to provide crucial support to CRAs as a co-monitor at sites whenever required, ensuring the seamless execution of clinical trials.

Supported the study team by managing ClinTrak modules, assisting with feasibility, and overseeing study supply distribution. I ensured TMF integrity, generated study documents, and collaborated effectively with Medpace and Sponsor teams.

As a Clinical Research Associate (CRA) with experience in various Phase 1 to 3 studies, including medical device trials, I managed pre-study, initiation, monitoring, and close-out visits according to SOPs and GCP. I oversaw site management, scheduled monitoring visits, and maintained study databases. My role included Phase II and III Study Site management, ensuring subject safety, and conducting adverse event reporting. I also handled investigative site file reconciliation and maintained accurate Investigator Site Files (ISF) aligned with the Trial Master File (TMF).

As an Assistant Professor, I instructed undergraduate and postgraduate courses in Molecular Biology and Recombinant DNA technology. I assessed and guided student activities, delivering comprehensive reports on their academic progress. I provided personalized assistance to students facing challenges, regularly monitoring their progress.

I employed innovative teaching techniques to enhance student learning outcomes, administered exams, and facilitated remediation to help students achieve their educational goals. Additionally, I played a pivotal role in supporting weekly lab sessions in Genetic Engineering, Biochemistry, Molecular Biology, and Recombinant DNA technology, fostering student engagement, comprehension, and the attainment of learning objectives.