Job Summary
The CPU Clinical Operations Manager (COM) provides strategic oversight and leadership for the clinical operations of the research unit, ensuring efficient management and seamless coordination. This role requires close collaboration with interdisciplinary teams to facilitate the successful execution of clinical research studies. All clinical personnel, including lab, pharmacy, and nursing staff, report directly to this position.
Oversee a range of critical operational tasks, ensuring adherence to established protocols and standards. Develop and implement strategic initiatives to enhance productivity, efficiency, and overall performance. Collaborate with cross-functional teams to drive project completion while maintaining high-quality deliverables. Monitor progress through performance metrics, identifying areas for improvement and implementing corrective actions as needed. Provide leadership and mentorship to team members, fostering a culture of accountability and continuous development. Serve as a key liaison between departments, facilitating seamless communication and alignment of objectives. Ensure compliance with organizational policies, industry regulations, and safety standards. Contribute to budget planning and resource allocation, optimizing financial and operational efficiency.
Clinical trial oversight and development encompass ensuring trials adhere to regulatory standards, maintaining ethical integrity, and managing study progression from initiation to completion. This involves coordinating with investigators, sponsors, and regulatory bodies, as well as implementing quality assurance measures to guarantee data accuracy and participant safety. Responsibilities include protocol development, risk management, compliance monitoring, and reporting findings to stakeholders while mitigating potential issues throughout the trial lifecycle.
The CPU Clinical Operations Manager (COM) will oversee the daily clinical operations of the Clinical Research Unit.
Supply leadership and strategic vision for the clinical operations of the unit while managing the nursing, pharmacy, and laboratory functions integral to clinical trials.
Responsible for coordinating the planning, launch, and implementation of research studies in partnership with principal investigators, their designees, and designated study teams.
Provide comprehensive oversight of patient clinical care throughout the duration of clinical trials, encompassing critical stages such as screening, informed consent acquisition, specimen collection, investigational drug administration, continuous patient management, and thorough completion of end-of-study documentation, in collaboration with relevant team members.
Protocol implementation, ensuring adherence to regulatory standards, and maintaining quality compliance.
Ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines. Provide training to staff, as needed.
Work collaboratively with managers, investigators, and sponsors to execute and oversee clinical components of study protocols while upholding adherence to regulatory standards.
Coordinate with AKUH,N managers and leadership to ensure compliance with institutional policies and JCI requirements.
Conduct thorough audits and inspections across all clinical trial components and unit-related elements to ensure compliance and operational excellence.
Enhanced quality metrics were observed through consistent internal quality assessments and documentation from monitoring visits.
Conducting comprehensive evaluations of educational resources utilized by nursing personnel, clinical coordinators, laboratory technicians, and pharmacy staff to ensure accuracy, relevance, and effectiveness.
Clinical evaluations and therapeutic interventions are conducted, with ongoing vigilance in safety oversight and documentation of incidents.
Offer expert counsel on clinical evaluations, therapeutic actions, and procedural steps mandated by study protocols.
Quarterly, conduct a thorough review of safety data, including Suspected Unexpected Serious Adverse Reactions (Sugars), Serious Adverse Events (SAE’s), and Investigator Brochures, to assess trends and highlight areas for improvement in learning.
Responsibilities include managing the surveillance and documentation of adverse events and safety issues.
Ensure that all reporting to regulatory authorities and study sponsors is completed timely and accurately.
We are seeking a dynamic professional to oversee leadership initiatives and supervise staff operations, ensuring alignment with organizational goals. This role involves guiding teams, fostering collaboration, and driving performance through strategic direction and mentorship. Responsibilities include talent development, conflict resolution, and maintaining a productive work environment. The ideal candidate will possess strong interpersonal skills, proven leadership experience, and the ability to motivate and inspire teams toward achieving excellence.
Offer strategic leadership and direct line management to research nurses, study coordinators, pharmacy staff, and laboratory personnel.
Plan, manage, and optimize workforce allocation, recruitment, onboarding, and retention strategies to guarantee sufficient staffing levels that align with study workload and organizational expansion objectives.
Collaborate with colleagues at AKU to maintain consistency in roles and responsibilities.
Develop and implement measurable performance objectives while performing consistent evaluations in alignment with established HR policies and procedures.
Assess and address staff training and professional development requirements to enhance skills and competencies.
Cultivate an environment characterized by ongoing quality enhancement and collaborative efforts.
Quality Assurance professionals are responsible for ensuring that products, services, and processes meet established standards and regulatory requirements. They develop and implement comprehensive training programs to enhance staff competence and maintain compliance with industry best practices. Additionally, they educate teams on quality protocols, risk mitigation strategies, and continuous improvement methodologies to foster a culture of excellence and accountability across the organization.
Oversee operational aspects of quality assurance processes within all Clinical Research Unit functions, maintaining stringent standards in clinical practice, data integrity, and study documentation.
Perform regular quality assessments and internal audits to verify the precision, thoroughness, and punctuality of clinical research documentation.
Deliver strategic leadership in capacity building and workforce development initiatives aimed at bolstering both existing and prospective research portfolios.
Lead in the planning of development, review of Standard Operating Procedures (SOPs) for clinical research operations.
You will deliver comprehensive training and educational programs to clinical staff, focusing on study protocols, Good Clinical Practice (GCP), and pertinent procedures.
Remain abreast of the latest advancements in clinical research and share pertinent findings with colleagues to foster collective awareness.
Conduct thorough evaluations of feasibility studies to determine the viability of proposed projects, analyzing key factors such as technical, economic, and operational considerations. Assess potential risks and benefits, ensuring alignment with organizational goals and regulatory requirements. Collaborate with stakeholders to gather necessary data, validate assumptions, and refine assessment methodologies. Prepare detailed reports outlining findings, recommendations, and actionable insights to support informed decision-making.
Collaborate with Investigators to evaluate emerging research and assess the feasibility of clinical trial protocols.
Oversee the administration and allocation of financial resources to ensure efficient and responsible use of the allocated budget. Develop and maintain detailed budget plans, including forecasting, monitoring expenditures, and identifying variances between actual and projected costs. Prepare regular financial reports to provide transparency and accountability to stakeholders. Collaborate with department heads to align budgetary allocations with strategic objectives and operational needs. Analyze spending patterns to recommend cost-saving measures while maintaining service quality. Ensure compliance with financial policies, regulations, and internal controls. Present budget proposals, justifications, and adjustments to senior management for approval.
Play a pivotal role in establishing and overseeing budgets specifically dedicated to clinical trial operations, ensuring financial alignment with study objectives and regulatory standards.
Monitor and oversee financial expenditures related to clinical resources and services to ensure efficient and responsible allocation of funds.
The position requires active engagement in the strategic planning and direction of the CPU, contributing to key decisions that shape the unit’s future.
Assist the Director of the Cancer Center in developing and implementing strategic plans for the Clinical Research Unit (CPU).
Periodically, additional responsibilities may be assigned as needed.
Requirements
A master’s degree in a health-related discipline—such as nursing, bioethics, clinical research, or public health—or a bachelor’s degree in a health field like nursing, laboratory science, or pharmacy, supplemented by a minimum of seven years of clinical experience, is required.
Proficiency in established clinical research standards (e.g., CITY or equivalent training) is essential, along with demonstrated engagement in international professional bodies such as ABACI, CRY, SACRA, ACRE, or comparable organizations.
Must possess a current and valid Nursing Council of Kenya (NCK) license.
Advanced Cardiovascular Life Support (ACLS) certification is mandatory for this position.
Relevant Experience
Minimum seven years of professional experience in clinical research is required, with a minimum of five years dedicated to direct involvement in clinical trials.
Develops and maintains comprehensive budgets with a high degree of proficiency, demonstrating an in-depth knowledge of financial planning and resource allocation.
Professional experience in collaborating with clinical, regulatory, laboratory, and pharmacy personnel is essential for effective clinical trial implementation.
Proficiency in conducting and engaging in audit and/or accreditation procedures, specifically those pertaining to standards of care practices and/or research, is necessary.
Proficient understanding of Good Clinical Practices (GCPs), clinical trial methodologies, nursing patient care protocols, biomaterial handling procedures, and health safety regulations.
Strong competencies in operating computers and utilizing essential office productivity software, including Outlook, Microsoft Word, Excel, and PowerPoint, are required.
We are seeking a candidate whose personal attributes and professional conduct align with the demands of this role. Integrity, adaptability, and a collaborative mindset are essential to thrive in this environment. Strong interpersonal skills and emotional intelligence facilitate effective teamwork and client interactions. Resilience under pressure and a proactive approach to problem-solving are highly valued. The ideal professional demonstrates accountability, attention to detail, and a commitment to continuous improvement. Ethical decision-making and a customer-centric focus remain fundamental expectations.
Proven ability to foster strong interpersonal relationships and communicate effectively through both written and verbal channels.
Accomplished leaders with a proven track record in guiding teams and driving organizational success through strategic decision-making and effective collaboration.
Highly developed organizational skills are essential, along with the capacity to efficiently manage a wide range of responsibilities across multiple studies and clinics concurrently.
Demonstrates the capacity to operate autonomously with a high degree of professionalism and self-sufficiency. Exhibits emotional intelligence, sound judgment, and the discipline to manage responsibilities without constant oversight. Thrives in environments where initiative, accountability, and problem-solving are valued.
Requires the ability to adapt seamlessly to diverse responsibilities within the healthcare field, including clinical and nursing care, patient services support, lab and bio-specimen processing, as well as data management. Demonstrates proficiency in performing a broad range of related duties across these key operational areas.
Proactively works both independently and collaboratively as part of a cohesive team to achieve shared objectives.
Professional capacity to perform effectively under pressure while ensuring timely delivery of assignments is essential.
Proficiency in collaborating effectively within diverse cultural settings is required, ensuring seamless integration and mutual respect among team members from varied backgrounds.
Developed exceptional abilities in fostering meaningful connections and facilitating clear, effective communication across diverse groups and individuals.
Qualifications
BA/BSc/HND , MBA/MSc/MA
Experience Required
7 years
