Daveline Nyaenya

Principal Clinical Team Manager | April 2024 – Present

Senior Clinical Team Manager | April 2021 – March 2024

Clinical Team Manager (CTM) | November 2017 – March 2021

• Served as Clinical Site Manager ( combined role as Project Lead and Team Manager) on two projects from 2019 to present), overseeing end-to-end project execution, budget management (including invoice review and approval), and deliverable oversight.
• facilitated monthly client meetings and submitted comprehensive summaries, ensuring consistent communication and project alignment.
• Influenced cross-functional strategic decision-making by preparing and presenting critical program updates to senior leadership and external stakeholders, securing buy-in for key development milestones.
• Proactively identified and mitigated strategic and operational risks across the global portfolio, preventing [X] potential critical delays and ensuring continuity of key programs.
• Led in the review and revision of the DAIDS Score Manual.
• Contributed directly to new business generation through bid defense
• Orchestrated and facilitated monthly team meetings. Managed a team of over 70 CRAs, 3 clinical research coordinators and 6 Clinical Team Managers.
• Led in initiatives to scale up revenue and growth for the company by close project analysis and proposition to the client for budget adjustment commensurate to project work at hand.
• Piloted and implemented an innovative process improvement for remote pharmacy assessments in Haiti, enabling complete assessments virtually and receiving positive feedback from DAIDS' Pharmacy Affairs Branch, now incorporated into the NCSM project.
• Developed and managed comprehensive risk mitigation strategies through RACT (Risk Assessment and Control Tool)
• Led routine client meetings
• Proactively reviewed and strategized on addressing monitoring backlogs
• Coordinated global resourcing efforts working closely with regional leads
• Generated quarterly and annual technical progress reports Highlighting project progress and performance.
• Led quality improvement initiatives, identifying areas for improvement and implementing strategic action plans to address deficiencies.
• Enhanced teamwork and collaboration among staff members by implementing regular team meetings and open communication channels.
• Fostered a culture of accountability by setting clear performance expectations and providing constructive feedback to team members.
• Monitored key performance indicators, utilizing data-driven decision-making to optimize clinic performance.
• Promoted a culture of continuous learning through professional development opportunities for all team members.
• Implemented evidence-based practices into clinical workflows to improve overall patient outcomes.
• Facilitated seamless transitions of care for patients by establishing strong relationships with external healthcare providers.
• Provided expert guidance on complex cases, offering consultative support to clinicians during difficult decision-making processes.
• Managed financial resources prudently, optimizing budgets while maintaining high-quality project deliverable standards.
• Boosted staff morale, promoting a positive work environment through recognition programs and ongoing support.

Principal Clinical Research Associate | April 2017 - October 2017

Senior Clinical Research Associate | April 2014 - March 2017

Clinical Research Associate | November 2011 - March 2014

• Maintained site monitoring schedules to facilitate effective communication with members of clinical team.
• Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
• Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
• Implemented electronic data capturing systems to adhere with clinical research guidelines.
• Collaborated with cross-functional teams to successfully meet project timelines and deliverables.
• Conducted clinical trial in accordance with protocol and recorded and monitored progress.
• Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
• Enhanced data quality by closely monitoring study progress and ensuring accurate data collection.
• Supported the successful completion of clinical trials by proactively managing risks and addressing challenges throughout all stages of the study process.
• Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations.
• Facilitated timely resolution of issues through effective communication with investigators, sponsors, and other stakeholders.
• Liaised with clinical project leader to effectively resolve study-related issues.
• Maintained comprehensive knowledge of applicable regulations and guidelines, ensuring full compliance throughout all stages of clinical trials.
• Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
• Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
• Facilitated quality of clinical trials by establishing project schedules and monitoring support to encourage accuracy and efficiency.
• Maintained awareness of industry trends by attending conferences and participating in relevant professional development opportunities.
• Reviewed data queries and listings and worked with study centers to resolve data discrepancies.
• Managed multiple projects simultaneously while maintaining a high level of attention to detail and meeting deadlines.
• Mentored team members by sharing suggestions and encouraging ideas to deliver successful studies.
• Developed strong relationships with investigators and site personnel to ensure ongoing compliance with study requirements.

• Strategic Oversight: Spearheaded a multi-country reciprocal monitoring initiative across 5 East African nations, funded by EDCTP, driving substantial improvements in regional clinical trial monitoring capacity.
• Financial Stewardship: Expertly managed and reconciled budgets for this international program, ensuring optimal resource allocation and financial efficiency.
• Capacity Building: Fostered collaboration and knowledge sharing among diverse teams, enhancing the overall effectiveness and sustainability of clinical trial monitoring efforts.
• Regularly reported on monitoring progress and results to senior management, ensuring transparency and accountability within the team.
• Developed strong relationships with external partners, facilitating smooth coordination during collaborative monitoring efforts.
• Implemented risk mitigation strategies throughout the project lifecycle to minimize potential disruptions or delays in achieving desired outcomes.

• Quality Branch Leadership: Directed quality management processes across multiple research units at the CDC Campus, including Demographics and Surveillance, Malaria, International Emerging Infections Program (IEIP), HIV, Tuberculosis, accredited Laboratories, and Research Clinics.
• Regulatory Excellence: Established and maintained robust quality assurance frameworks, ensuring full IRB/ERC regulatory approvals and compliance for numerous Malaria and HIV studies.
• Training and Development: Organized and delivered comprehensive GCP training programs for study staff, significantly enhancing adherence to international standards and reducing protocol deviations by 70%.
• Managed root cause analysis investigations, determining underlying issues in product failures and implementing corrective actions as necessary.
• Managed and archived quality documentation and participated in internal and external quality audits.