Job Summary
The CPU Clinical Operations Manager (COM) provides leadership and oversight of the research unit’s clinical operations, ensuring seamless planning, execution, and management of clinical research studies through collaboration with interdisciplinary teams. This role serves as the supervisory point of contact for all clinical personnel, including lab, pharmacy, and nursing staff, to maintain operational efficiency and compliance throughout study conduct.
Oversee a variety of essential tasks to ensure seamless operations and uphold high standards of quality and efficiency. Develop and implement strategic plans aligned with organizational objectives, while fostering collaboration across departments to drive cohesive progress. Monitor performance metrics regularly to identify areas for improvement and implement corrective actions as needed. Provide guidance and mentorship to team members to enhance their skills and contribute to professional growth. Maintain compliance with industry regulations and internal policies to mitigate risks and ensure accountability. Serve as a primary point of contact for stakeholders, addressing concerns and facilitating clear, timely communication.
Clinical trials require meticulous oversight and strategic development to ensure compliance, efficacy, and safety throughout the research process. This role involves establishing robust frameworks for monitoring trial progress, adhering to regulatory standards, and managing cross-functional teams to drive successful trial execution. Responsibilities include reviewing trial protocols, assessing risks, and ensuring adherence to Good Clinical Practice (GCP) guidelines. Additionally, the position demands coordination with investigators, sponsors, and regulatory bodies while maintaining comprehensive documentation to support trial integrity and data accuracy. A strong background in clinical research, regulatory knowledge, and leadership skills is essential for overseeing these critical operations.
The CPU Clinical Operations Manager (COM) will oversee the daily clinical operations of the Clinical Research Unit.
Offer strategic leadership and direction to the clinical unit while managing the nursing, pharmacy, and laboratory aspects of clinical trials.
Responsible for directing the development, launch, and implementation of research studies in partnership with principal investigators, their delegates, and study team members.
Responsible for comprehensive oversight of clinical trial patient care, encompassing screening, informed consent acquisition, specimen collection, investigational product administration, continuous clinical management, and completion of end-of-study documentation in collaboration with relevant team members.
Protocol implementation, regulatory adherence, and quality compliance are essential components of this role, requiring meticulous attention to detail and a comprehensive understanding of industry standards and guidelines. The successful candidate will ensure that all procedures align with established protocols, regulatory requirements, and quality benchmarks, thereby mitigating risks and maintaining operational integrity. Strong analytical skills and the ability to interpret complex guidelines will be crucial in executing these responsibilities effectively.
Ensure strict compliance with study protocols, regulatory mandates, and Good Clinical Practice (GCP) guidelines. Deliver training to staff whenever necessary to uphold these standards.
Work collaboratively with managers, investigators, and sponsors to execute and oversee the clinical components of study protocols while ensuring adherence to all regulatory requirements.
Collaborate closely with AKU leadership and management teams to uphold institutional policies and meet JCI accreditation standards.
Conduct thorough audits and inspections of all clinical trial components and unit-related elements to ensure adherence to established protocols and regulatory standards.
Consistently enhanced quality metrics, as evidenced by regular internal quality checks and monitoring visit reports.
Conduct thorough assessments of educational resources intended for nurses, clinical coordinators, laboratory personnel, and pharmacy staff to ensure accuracy and effectiveness.
Conducting thorough clinical evaluations and implementing targeted interventions, along with vigilant safety oversight and comprehensive reporting, are central responsibilities of this role.
Offer expert direction on clinical evaluations, therapeutic actions, and procedural steps mandated by study protocols.
Quarterly, conduct a comprehensive review of safety data—including Suspected Unexpected Serious Adverse Reactions (Sugars), Serious Adverse Events (SAE’s), and Investigator Brochures—to assess emerging trends and pinpoint areas requiring further education or improvement.
Responsible for the oversight of adverse event and safety concern monitoring and reporting.
Furnish regulatory authorities and study sponsors with precise and punctual reports as mandated by applicable guidelines and agreements.
Seasoned professionals sought to oversee team dynamics and drive organizational success through adept leadership and strategic staff management. Responsibilities encompass guiding teams toward peak performance, fostering a collaborative work environment, and ensuring alignment with company objectives. Candidates must demonstrate proven experience in team leadership, conflict resolution, and talent development to excel in this role. Strong communication, decision-making, and problem-solving skills are essential, along with the ability to mentor and motivate cross-functional teams.
Deliver strategic guidance and direct supervision to research nurses, study coordinators, pharmacy staff, and laboratory personnel to ensure operational excellence and adherence to protocols.
To coordinate workforce allocation, recruitment, onboarding, and retention efforts, ensuring staffing levels meet study workload demands and support unit growth.
Collaborate with counterparts at AKU to maintain consistency in roles and responsibilities.
Develop well-defined performance benchmarks and execute periodic performance evaluations in accordance with organizational HR guidelines.
Assess and address staff training and professional development requirements to enhance skills and performance.
Champion a culture centered on ongoing quality enhancement and collaborative teamwork.
Quality Assurance specialists are responsible for ensuring product and service excellence through rigorous testing, compliance verification, and process improvements. They develop and deliver comprehensive training programs to enhance staff competencies and operational efficiency. Additionally, they provide ongoing education initiatives to keep teams updated on industry standards, regulatory changes, and best practices, fostering a culture of continuous learning and adherence to quality benchmarks.
Oversee operational activities related to quality assurance processes throughout all Clinical Research Unit functions, maintaining stringent adherence to clinical practice standards, data integrity, and study documentation protocols.
Perform systematic quality assessments and internal audits to verify the accuracy, completeness, and timely submission of clinical research documentation.
Offer strategic leadership in capacity building and workforce development initiatives to enhance support for both existing and prospective research portfolios.
Responsible for spearheading the development and evaluation of Standard Operating Procedures (SOPs) pertaining to clinical research operations.
Deliver instructional sessions and educational programs to clinical personnel regarding study protocols, Good Clinical Practice (GCP), and pertinent operational procedures.
Maintain current awareness of advancements in clinical research and share pertinent insights with the team.
Conduct thorough evaluations of project viability to determine feasibility by analyzing key factors such as technical requirements, resource availability, budget constraints, and potential risks. Assess whether objectives can be met within specified timelines and identify any gaps or obstacles that may hinder success. Provide detailed reports outlining findings, recommendations, and actionable insights to support informed decision-making. Collaborate with stakeholders to gather necessary data, validate assumptions, and refine assessments as needed. Ensure compliance with organizational standards and industry best practices throughout the evaluation process.
Collaborate with Investigators to evaluate emerging research and assess the feasibility of clinical trial protocols.
Oversee financial planning, allocation, and monitoring to ensure efficient use of resources while maintaining fiscal responsibility and alignment with organizational goals. Track expenditures, analyze variances, and implement corrective actions to optimize budget performance. Prepare financial reports, forecasts, and variance analyzes to support decision-making and ensure compliance with budgetary policies and regulations. Collaborate with department heads to develop and adjust budgets based on operational needs and strategic priorities.
Prepare and oversee budgets associated with clinical trial operations to ensure fiscal efficiency and alignment with project objectives.
Oversee and regulate expenditures associated with clinical resources and services to ensure efficient allocation and adherence to budgetary constraints.
We contribute to the formulation and implementation of the CPU’s strategic planning initiatives, ensuring alignment with overarching organizational goals. Additionally, we provide guidance on the CPU’s long-term direction, optimizing resource allocation to drive sustainable growth and operational excellence. Our role includes evaluating market conditions, identifying emerging opportunities, and advising senior leadership on key decisions to maintain a competitive edge. Collaboration with cross-functional teams and stakeholders is essential to execute strategic directives effectively.
Provide strategic planning assistance to the Director of the Cancer Center, focusing on the CPU’s objectives and initiatives.
Performing additional tasks as needed may be required periodically.
Requirements
A master’s degree in a health-related field—such as nursing, bioethics, clinical research, or public health—is required, or a bachelor’s degree in a health discipline like nursing, laboratory science, or pharmacy, supplemented by a minimum of seven years of hands-on clinical practice.
Proficiency in established clinical research standards, evidenced by completion of recognized training programs such as CITY or equivalent, along with demonstrated engagement in prominent international organizations—including ABACI, CRY, SACRA, ACRE, or comparable entities—is essential.
Must possess a current and valid Nursing Council of Kenya (NCK) license in good standing.
Advanced Cardiovascular Life Support certification is a mandatory prerequisite for this position.
Relevant Experience
A minimum of seven years of professional experience in clinical research is required, with a minimum of five years dedicated to direct involvement in clinical trials.
We possess a strong command of budgeting principles and practices, coupled with extensive experience in their development and execution. Our expertise encompasses the creation, monitoring, and management of budgets to ensure financial accuracy and alignment with organizational objectives.
Proficiency in collaborating with clinical, regulatory, laboratory, and pharmacy personnel is essential for the effective execution of clinical trials. Experience in interfacing with these stakeholders to ensure smooth trial implementation is required.
Proficiency in navigating and contributing to audit and/or accreditation procedures, particularly concerning standards of care and/or research practices, is required.
Proficiency in Good Clinical Practices (GCPs), clinical trial methodologies, nursing patient care standards, and biomaterials handling, along with adherence to health and safety protocols, is required.
Demonstrated expertise in operating computers and utilizing essential office applications, including Outlook, Microsoft Word, Excel, PowerPoint, and similar software, is required.
Seeking an individual who demonstrates strong interpersonal skills, a proactive mindset, and the ability to collaborate effectively within a team. The ideal candidate will exhibit adaptability, professionalism, and a commitment to continuous improvement. Problem-solving abilities and a solution-oriented approach are essential, along with excellent communication skills to engage with stakeholders at all levels. Integrity, accountability, and a customer-focused attitude are highly valued traits.
Proven ability to foster strong interpersonal relationships and convey information effectively through clear written and verbal communication.
Demonstrates exceptional ability to lead and manage teams effectively, fostering collaboration and driving organizational success through strategic decision-making and clear communication.
Highly developed organizational skills with the capacity to manage a variety of tasks across multiple studies and clinics concurrently.
Demonstrates a high level of professional maturity and the capacity to operate effectively with minimal supervision. Exhibits strong self-management skills and the ability to make sound decisions autonomously in a dynamic work environment.
Able to adapt seamlessly across multiple interconnected functions, including clinical and nursing care, patient services support, laboratory and biospecimen processing, as well as data management.
Demonstrates the ability to work independently with minimal supervision while effectively collaborating with team members to achieve shared objectives.
Demonstrates resilience and composure in high-pressure environments while consistently delivering results within specified timelines.
Proven capacity to thrive in diverse, multicultural settings, demonstrating cultural sensitivity and adaptability.
Proven ability to communicate effectively with colleagues, clients, and stakeholders, fostering strong professional relationships and ensuring smooth collaboration across teams. Demonstrated capacity to listen actively, resolve conflicts diplomatically, and adapt communication styles to diverse audiences for optimal engagement and mutual understanding.
Qualifications
BA/BSc/HND , MBA/MSc/MA
Experience Required
7 years
