Clinical Monitoring Team

At Xcene Research, the Clinical Monitoring Team ensures that every trial conducted across Sub-Saharan Africa upholds the highest standards of quality, compliance, and patient safety.

Our monitoring professionals work collaboratively to maintain scientific integrity, regulatory adherence, and operational excellence across all sites, whether on-site, remote, or decentralized.

The team includes Clinical Research Associates (CRAs), Remote CRAs, and Decentralized CRAs each playing a vital role in ensuring data accuracy, ethical conduct, and study continuity

Clinical Research Associate

Xcene Research Clinical Research Associates (CRAs) play a critical role in ensuring the integrity and success of clinical trials across Sub-Saharan Africa. CRAs oversee multiple investigator sites, monitoring compliance with study protocols, Good Clinical Practice (GCP), and sponsor requirements.

They are responsible for site management, trial monitoring, data verification, documentation review, and process improvement, while also supporting site selection, investigator training, and mentorship of junior CRAs.

Remote Clinical Research Associate (Remote CRA)

Remote CRAs at Xcene Research provide centralized monitoring support for clinical trials across Sub-Saharan Africa. Working within our digital trial environment, they review eSource and EDC data, verify site documentation, track enrollment and protocol adherence, and maintain continuous communication with on-site teams.

They ensure that studies remain compliant with ICH-GCP, sponsor protocols, and regulatory standards driving quality oversight through technology-enabled, risk-based monitoring.

Decentralized Clinical Research Associate (CMA)

Decentralized CRAs (Clinical Monitoring Associates) support hybrid and virtual trial models using digital and mobile-health platforms. They coordinate remote patient follow-up, eConsent verification, and data collection through tele-engagement tools. By bridging patients, investigators, and digital systems, they enhance recruitment, retention, and real-time oversight helping Xcene Research expand access to high-quality, inclusive clinical research across Africa’s diverse populations.

These roles demand strong organizational, communication, and relationship-management skills, as well as proficiency in digital monitoring systems and time and budget control. A bachelor’s degree in life sciences, pharmacy, nursing, or a related field (or equivalent experience) is required.

Project Management Team

At Xcene Research, the Project Management Team integrates both Study Management and Laboratory Management functions, working collaboratively to ensure the seamless execution and integrity of every clinical and laboratory study.

The Laboratory Management Team serves as a unique bridge between clinical operations and scientific data management. This group plays a critical role in safeguarding laboratory data integrity, ensuring that all sample handling, analysis, and reporting adhere to GCP, GLP, and ISO 15189 standards.

Together, the Project Management Team orchestrates Xcene’s research operations with precision delivering studies that are scientifically robust, operationally efficient, and globally compliant.

The Project Management Division at Xcene Research encompasses specialized roles that work collaboratively to ensure operational excellence, scientific rigor, and data integrity across all studies. Key roles within the PM function include:

  • Project Manager 
    At Xcene Research, project managers are the maestros conducting the symphony of clinical trials. They oversee the entire project lifecycle, from study start-up to successful completion and reporting. Their role involves meticulously crafting the project plan and budget, leading and motivating the cross-functional clinical research team, and fostering clear communication with sponsors and internal stakeholders. Proactive risk management and meticulous adherence to regulations and Xcene’s SOPs are crucial aspects of their work. By diligently documenting progress and ensuring all reporting requirements are met, Xcene’s project managers play a pivotal role in delivering high-quality, compliant research.
  • Clinical Trial Lead 
    At Xcene Research, the Clinical Trial Lead spearheads clinical monitoring and site management for assigned studies, guiding the team to deliver high-quality results while staying on budget. They collaborate with clients and internal departments, contribute to business development, and ensure compliance with strict protocols and deadlines.
  • Clinical Project Specialist 
    The Clinical Project Specialist (CPS) is crucial for coordinating and supporting Clinical Operations and Project Managers. Responsibilities include ensuring compliance with contracts, SOPs, and policies, managing the clinical trial system, optimizing budgets, acting as a subject matter expert, and maintaining project data. Strong communication, organization, and knowledge of clinical research concepts are essential. A bachelor’s degree in life sciences or related fields is preferred. Up to 30% travel may be required.
  • Clinical Laboratory Manager 
    The Clinical Laboratory Manager (CLM) ensures accurate data delivery in clinical trials, acting as the main contact for lab data management. They oversee sample processing, monitor operations, and ensure efficiency and compliance. The ideal candidate holds a bachelor’s degree in medical laboratory science, with strong lab test knowledge and teamwork skills.
  • Clinical Laboratory Specialist
    The Clinical Laboratory Specialist (CLS) at Xcene Research ensures accurate data production and delivery across clinical trial phases. They manage lab data, oversee sample processing, lead cross-functional teams, and coordinate logistical aspects of trials. Responsible for project management, regulatory compliance, and vendor management, the CLS maintains quality projects and addresses issues promptly.
  • Medical Monitoring & Pharmacovigilance Team
    At Xcene Research, the Medical Monitoring and Pharmacovigilance Team ensures that participant safety and data integrity remain at the heart of every study. This team provides continuous medical oversight and safety management across all clinical programs, supporting both interventional and observational studies throughout Sub-Saharan Africa. Our Medical Monitors and Safety Specialists collaborate closely with investigators, sponsors, and regulatory authorities to evaluate adverse events, manage safety reporting, and ensure full compliance with ICH-GCP, FDA, EMA, and local regulatory requirements. Using advanced safety databases, signal-detection tools, and real-time analytics, the team proactively identifies, assesses, and mitigates potential risks throughout the trial lifecycle. Their medical insight ensures the accuracy, consistency, and clinical relevance of all safety data generated. A medical degree (MD, MBBS, or equivalent) and prior experience in pharmacovigilance or clinical research safety monitoring are preferred.

Quality Assurance Specialist

At Xcene Research, the Quality Assurance Specialist safeguards the quality of clinical trials by guiding and monitoring adherence to research regulations and protocols. They manage documentation, train staff, support trial execution, and lead or participate in audits, risk management, and quality-related collaborations. This position demands strong leadership, communication, and problem-solving skills in a dynamic environment. A bachelor’s degree in life sciences and relevant experience are essential. 

Regulatory Affairs Specialist

At Xcene Research, the Regulatory Specialist expertly guides the preparation and submission of clinical trial applications for Sub-Saharan Africa, ensuring strict adherence to international regulations and company standards. They develop submission strategies, manage regulatory tasks, collaborate with study teams, and ensure the timely and accurate submission of documents. Success in this role requires sharp analytical and communication skills, along with a relevant bachelor’s degree and some experience in regulatory affairs. 

Clinical Trial Associate

Clinical Trial Associate bolsters the expanding study pipelines. They work closely with CRAs and Regulatory teams. This role ensures efficient Trial Master File delivery through daily administrative tasks. Responsibilities include maintaining compliance metrics, overseeing clinical systems, managing documentation, mentoring junior staff, aiding TMF development, handling CRFs and data flow, facilitating project communications, ensuring inspection readiness, and supporting trial execution. The role requires computer proficiency, meticulous attention to detail, strong organizational skills, and excellent communication abilities. A bachelor’s degree (or equivalent) in life sciences or a related field is mandatory.