Job Summary
The CPU Clinical Operations Manager (COM) leads and directs the clinical operations of the research unit, overseeing all aspects of study execution. This role involves providing leadership, coordinating efforts, and fostering collaboration among interdisciplinary teams to facilitate the effective implementation and execution of clinical research studies. All clinical staff, including lab, pharmacy, and nursing personnel, report directly to this position.
The role encompasses a diverse array of duties, including managing daily operations to ensure seamless workflow, collaborating with cross-functional teams to drive project success, and implementing innovative strategies to enhance efficiency. Key responsibilities involve overseeing budget allocations, maintaining compliance with industry regulations, and fostering a productive work environment. Additionally, the position requires analyzing performance metrics to identify opportunities for improvement, communicating progress to stakeholders, and mentoring junior team members to cultivate leadership skills. The ideal candidate must possess strong organizational abilities, exceptional problem-solving capabilities, and the adaptability to navigate evolving business challenges.
Clinical trial oversight and development encompass critical responsibilities to ensure trials are conducted safely, ethically, and in compliance with regulatory standards. This role involves collaborating with cross-functional teams to design, implement, and monitor clinical studies, while adhering to protocols, timelines, and quality assurance measures. Key duties include managing regulatory submissions, maintaining documentation, and addressing any deviations or safety concerns that arise during the trial process. Additionally, the position requires strong attention to detail, critical thinking, and the ability to interpret complex scientific and regulatory guidelines to mitigate risks and ensure data integrity.
The Clinical Operations Manager (COM) for the CPU will oversee daily clinical operations within the Clinical Research Unit.
Provide strategic leadership and direction to the clinical aspect of the unit while ensuring oversight of nursing, pharmacy, and laboratory functions in clinical trial operations.
Responsible for managing the planning, commencement, and implementation of research studies in partnership with principal investigators/designees and study teams.
Responsible for managing every facet of patient care within clinical trials, including screening, obtaining informed consent, collecting samples, administering medications, providing continuous care, and ensuring accurate end-of-study documentation, in collaboration with relevant team members.
Protocol implementation, adherence to regulatory standards, and maintenance of quality compliance are integral components of this role’s responsibilities.
Ensure compliance with study protocols, applicable regulatory standards, and Good Clinical Practice (GCP) guidelines. Deliver training sessions to staff as required.
Work closely with managers, investigators, and sponsors to execute and oversee clinical components of study protocols while ensuring adherence to all regulatory standards and guidelines.
Collaborate with AKU leadership and management teams to uphold adherence to institutional policies and JCI standards.
Conduct audits and inspections for all clinical trial components and Unit-related aspects, ensuring compliance with established standards.
Consistently enhanced quality standards were evidenced by systematic internal quality assessments and comprehensive monitoring visit documentation.
Quality assurance of educational resources for nursing personnel, clinical coordinators, laboratory technicians, and pharmacy staff.
Clinical assessments and interventions are conducted, with a strong emphasis on patient safety and meticulous monitoring, while ensuring comprehensive reporting of all findings.
Offer expert direction regarding clinical evaluations, therapeutic actions, and procedural protocols as dictated by study requirements.
Conduct quarterly evaluations of safety data, including Serious Unexpected Suspected Adverse Reactions (Sugars), Serious Adverse Events (SAE’s), and Investigator Brochures, to assess trends and highlight areas for improvement.
Monitor and report adverse events and safety concerns to ensure compliance with regulatory standards.
Deliver prompt and precise reports to regulatory bodies and study sponsors as mandated.
Leadership & Staff management
Offer strategic direction and operational oversight to research nurses, study coordinators, pharmacy staff, and laboratory personnel.
Develop and manage strategies for staffing levels, hiring processes, new employee integration, and employee retention to guarantee sufficient personnel to meet study demands and support organizational expansion.
Collaborate with counterparts at AKU to ensure alignment of roles and responsibilities.
Develop and implement well-defined performance objectives while executing consistent performance evaluations in accordance with the organization’s established HR policies.
Conduct a thorough assessment to determine staff training and professional development requirements, then implement tailored solutions to address those needs effectively.
Promote a collaborative environment that champions ongoing quality enhancement and collective effort.
We are seeking a dedicated Quality Assurance professional to develop, implement, and oversee training and educational programs aimed at enhancing organizational standards and compliance. The ideal candidate will possess expertise in designing instructional materials, evaluating training effectiveness, and ensuring that employees adhere to established quality protocols. Responsibilities include conducting needs assessments, delivering engaging training sessions, and maintaining comprehensive records of training outcomes. Additionally, the candidate will collaborate with cross-functional teams to identify gaps in knowledge and implement corrective measures to uphold excellence in quality assurance practices.
Ensure comprehensive operational supervision of quality assurance processes throughout all Clinical Research Unit operations, maintaining stringent standards in clinical practice, data accuracy, and study documentation.
Perform regular quality assessments and internal audits to verify the precision, thoroughness, and punctuality of clinical research documentation.
Deliver strategic leadership to enhance capacity building and workforce development initiatives, thereby strengthening support for existing and anticipated research portfolios.
Drive the strategic planning and revision of Standard Operating Procedures (SOPs) for clinical research operations.
Deliver comprehensive training and educational programs to clinical staff focusing on study protocols, Good Clinical Practice (GCP), and pertinent procedures.
Monitor advancements in clinical research and ensure the team remains informed by sharing relevant updates and insights.
Conduct thorough evaluations to determine the viability of proposed studies, analyzing key factors such as methodological soundness, resource availability, regulatory compliance, and potential risks. This role involves collaborating with cross-functional teams to gather and interpret data, ensuring that each assessment aligns with organizational goals and scientific objectives. Additionally, prepare detailed reports summarizing findings, recommendations, and any necessary adjustments to enhance study feasibility and success.
Collaborate with Investigators to evaluate recent research findings, ensuring alignment with feasibility assessments and clinical trial protocol reviews.
Oversee the administration and strategic allocation of financial resources to ensure the efficient and effective execution of organizational objectives. Develop, monitor, and adjust budgets in alignment with departmental goals and company-wide priorities. Analyze financial performance, identify variances, and implement corrective measures as needed to maintain fiscal responsibility. Collaborate with stakeholders across departments to forecast funding needs, secure approval for expenditures, and optimize resource utilization. Prepare comprehensive reports detailing budgetary status, trends, and recommendations for senior leadership. Ensure compliance with regulatory standards and internal policies while maintaining transparency and accountability in all financial activities.
Play a key role in creating, overseeing, and maintaining budgets for clinical trial operations, ensuring alignment with clinical activities.
Oversee the financial management of clinical resources and services, ensuring expenditures remain within allocated budgets while maintaining quality standards.
We play a key role in shaping the strategic planning and overall direction of the CPU, ensuring alignment with organizational objectives and fostering sustainable growth.
Provide strategic support to the Cancer Center Director in developing and executing comprehensive planning initiatives for the Clinical Research Unit (CPU).
Periodically, additional responsibilities may be assigned as needed.
Requirements
A Master’s degree in a health-related field, such as nursing, bioethics, clinical research, or public health, is required—or alternatively, a Bachelor’s degree in a health discipline (e.g., nursing, laboratory sciences, or pharmacy) coupled with a minimum of seven years of hands-on clinical experience.
Professionals should demonstrate familiarity with established clinical research standards, supported by certifications like CITY or equivalent training, and engage actively in internationally recognized organizations—including ABACI, CRY, SACRA, ACRE, or comparable bodies.
Must possess a current and valid Nursing Council of Kenya (NCK) license.
Advanced Cardiovascular Life Support (ACLS) certification is a mandatory prerequisite for this role.
Seeking candidates with proven expertise in the designated field, as evidenced by hands-on experience in related roles. Applicants must demonstrate a track record of success in positions that align with the core responsibilities of this opportunity. Familiarity with industry-specific tools, methodologies, and challenges is essential for effective performance. The ideal candidate will bring a minimum of [X] years of professional experience, ensuring they are well-equipped to contribute meaningfully from day one.
A minimum of seven years of professional experience in clinical research is required, with at least five of those years dedicated to hands-on involvement in clinical trial execution.
Experts should demonstrate extensive knowledge in financial planning and budget creation. This includes the ability to develop, manage, and analyze budgets with precision. Candidates must possess strong analytical skills to ensure accurate forecasting and efficient allocation of resources while maintaining financial accountability.
Proven expertise in collaborating with clinical, regulatory, laboratory, and pharmacy personnel to facilitate the execution of clinical trials.
Proficiency in conducting and contributing to audit and accreditation procedures, with a focus on maintaining standards of care and/or research practices, is required.
Proficient understanding of Good Clinical Practices (GCPs), clinical trial methodologies, nursing patient care protocols, biomaterials handling procedures, and health safety regulations.
Skilled in utilizing computers and essential office applications, including Outlook, Microsoft Word, Excel, PowerPoint, and similar tools.
We are seeking a professional who embodies a strong set of personal attributes and work-related behaviors essential for success in this role. Candidates must demonstrate reliability, integrity, and a proactive approach to problem-solving, along with exceptional communication skills to effectively collaborate with teams and stakeholders. Adaptability in dynamic environments and a commitment to continuous learning are equally important, as is the ability to maintain composure under pressure. Prioritizing ethical conduct, accountability, and a customer-focused mindset will be critical to thriving in this position.
Proficient in both written and verbal communication, with a strong ability to interact effectively with others.
Accomplished leadership and organizational capabilities are essential, with a proven track record of guiding teams to achieve strategic objectives.
Highly adept at managing several concurrent projects and clinical studies, with a strong capacity for multitasking and maintaining meticulous organization across diverse responsibilities.
Experienced professionals must demonstrate a high level of maturity and the capacity to function productively without continuous supervision. They should possess the self-discipline necessary to manage tasks efficiently and make sound decisions when working autonomously.
Demonstrated ability to excel across multiple interconnected functions, including clinical and nursing care delivery, patient services coordination, laboratory and bio-specimen processing operations, as well as comprehensive data management responsibilities.
Self-motivated professional capable of working both independently and collaboratively within a team setting.
Demonstrated capability to perform effectively under pressure while adhering to strict deadlines. Exhibits resilience in fast-paced environments and maintains high performance standards.
Proven capability to thrive in diverse, multicultural settings with sensitivity and adaptability.
You possess strong communication abilities and thrive in collaborative environments, demonstrating the capacity to engage effectively with colleagues and stakeholders alike.
Qualifications
BA/BSc/HND , MBA/MSc/MA
Experience Required
7 years
