Nina Chandra Email & Phone Number

Morrisville, Nc, Us

Oversee site management and clinical monitoring activities, upholding compliance with protocols, GCP, and regulatory requirements throughout the clinical trial lifecycle. Lead cross-functional teams, coordinating CRAs and Central Monitors, providing comprehensive training, and guaranteeing alignment with monitoring strategies and clinical plans. Act as the primary liaison for clients, resolving conflicts and collaborating to address clinical trial risks and ensure timely delivery of all project milestones. Develop clinical study tools and contribute to process improvements. Engage in business development by devising clinical operations strategies, creating budgets, and delivering client presentations.Highlights of accomplishments in this role include:• Mitigated protocol execution risks through strategic use of RACT and operational data, leveraging extensive experience in budget management, negotiation, forecasting, and evaluation to ensure project timelines, quality, and budget adherence.• Facilitated the seamless transition of trial responsibilities by bridging knowledge gaps and integrating extensive industry experience, thereby enhancing team cohesion and trial outcomes.• Mentored clinical trial managers, driving departmental initiatives that improved overall trial management capabilities and supported professional growth within the team.

Durham, North Carolina, Us

Directed all clinical aspects of designated projects, establishing robust cross-functional relationships to facilitate both internal and external stakeholder engagement. Oversaw the strategic planning, implementation, and management of global clinical trials, adhering to timelines, budgets, and quality standards. Served as a key liaison across regional teams, including Clinical Trial Managers (CTMs) and Clinical Research Associates (CRAs), fostering high-performance team dynamics, optimal resource utilization, and minimal turnover through comprehensive training initiatives. Administered vendor relationships while maintaining rigorous compliance with company processes and regulatory standards.Highlights of accomplishments in this role include:• Led a major study spanning 27 countries, monitoring a team of multiple direct reports, which culminated in successful project delivery and enhanced global trial operations.• Played a pivotal role in securing new business and developing clinical operations strategies and budgets that aligned with client expectations, resulting in a major increase in successful presentations and a 50% rise in client satisfaction.• Managed a study from startup to closeout, highlighting strong capabilities in handling complex clinical research processes and achieving rare industry milestones.• Devised and implemented innovative recruitment strategies, aligning study projections with actual performance and optimizing participant enrollment by 60%.

Dublin, Ie

Description: Supervised clinical trial activities for two significant U.S.-based studies, facilitating seamless coordination between project teams and adherence to study protocols, timelines, and regulatory requirements.Highlights of accomplishments in this role include:• Played a key role in driving project success, earning promotion to Senior Clinical Trial Manager due to excellent performance and the ability to lead complex clinical trials effectively.• Maintained high levels of study quality and compliance throughout all trial phases, contributing to the successful execution of clinical research projects.• Provided mentorship and professional development to junior clinical staff, fostering a culture of continuous improvement.

Dublin, Ie

Managed clinical operations project teams, including CRAs, SMAs, and CTAs, safeguarding compliance with ICH/GCP, SOPs, and study requirements. Tracked project deliverables, including enrollment and visit projections, and oversight of budget and finance tracking.Highlights of accomplishments in this role include:• Transitioned from Clinical Research Associate to Clinical Trial Manager, representing leadership in managing pivotal U.S.-based studies.• Cultivated strong working relationships with clients and clinical sites, guaranteeing seamless coordination and adherence to regulatory standards, which contributed to the timely initiation and execution of clinical trials.• Implemented risk mitigation strategies that resolved project-related issues, upheld quality standards, and ensured accurate tracking of study information, resulting in the consistent achievement of study metric requirements.• Offered comprehensive training and mentorship to CRAs and site management associates, enhancing team performance and assuring timely communication of study progress and processes across the clinical team.

Dublin, Ie

Controlled site start-up activities, including regulatory submissions and contract negotiations, while providing oversight for patient recruitment and retention strategies. Coordinated with site staff to confirm accurate and timely data collection, reporting, and resolution of discrepancies, while maintaining strong communication channels with study sponsors and internal teams.Highlights of accomplishments in this role include:• Monitored multiple clinical trial sites, adhering to study protocols and ICH/GCP guidelines, which contributed to the integrity and reliability of study data, resulting in a 50% reduction in data discrepancies and a 50% increase in data accuracy.• Played a key role in site start-up activities, including regulatory submissions and contract negotiations, leading to the timely initiation of clinical trials.• Collaborated and worked closely with site staff to implement effective patient recruitment and retention strategies, which resulted in meeting or exceeding enrollment targets.• Guaranteed accurate data collection and timely resolution of discrepancies while maintaining high data quality and compliance throughout the study.

Durham, North Carolina, Us

Columbia, Md, Us

Marlborough, Massachusetts, Us