Job Summary
The CPU Clinical Operations Manager (COM) oversees and directs the clinical operations of the research unit, providing leadership, coordination, and collaboration to interdisciplinary teams. This role ensures the effective implementation and execution of clinical research studies. All clinical personnel, including lab, pharmacy, and nursing staff, report to this position.
Oversee daily operations ensuring adherence to established protocols and standards. Collaborate with cross-functional teams to align objectives and drive project execution. Monitor performance metrics to identify trends and implement corrective actions as needed. Develop and maintain comprehensive documentation, including reports, policies, and procedures. Provide leadership and guidance to team members to foster a productive and inclusive work environment. Ensure compliance with regulatory requirements and company policies at all times.
Clinical trial oversight and development encompass the comprehensive management, strategic planning, and rigorous execution of clinical research initiatives to ensure compliance, safety, and efficacy. This role involves coordinating cross-functional teams, monitoring trial progress, and ensuring adherence to regulatory standards, ethical guidelines, and Good Clinical Practice (GCP) protocols. Responsibilities include reviewing trial protocols, managing investigator sites, and maintaining meticulous documentation to support data integrity and regulatory submissions. Additionally, the position requires collaboration with stakeholders, including sponsors, regulatory authorities, and study participants, to facilitate seamless trial execution and achieve study objectives.
The CPU Clinical Operations Manager (COM) will oversee the daily clinical operations of the Clinical Research Unit.
Offer strategic leadership and direction for the clinical aspects of the unit, while also supervising nursing, pharmacy, and laboratory operations within clinical trials.
Responsible for coordinating the planning, commencement, and implementation of research studies in partnership with principal investigators/designees and study teams.
Responsibilities include supervising the comprehensive clinical management of patients enrolled in clinical trials, encompassing screening, informed consent processes, specimen collection, administration of investigational drugs, continuous patient care throughout the trial duration, and completion of final documentation in collaboration with relevant team members.
Protocol implementation, adherence to regulatory standards, and maintenance of quality compliance are integral responsibilities of this role.
Ensure strict compliance with study protocols, regulatory mandates, and Good Clinical Practice (GCP) guidelines. Deliver training to staff, as circumstances require.
Collaborate with managers, investigators, and sponsors to execute and oversee the clinical components of study protocols while ensuring adherence to regulatory standards.
Collaborate with AKU management and leadership teams to uphold adherence to institutional policies and JCI standards.
Conduct comprehensive audits and inspections for every component associated with the clinical aspects of trials and the Unit.
Enhanced quality metrics were consistently evidenced by regular internal quality assessments and findings from monitoring visits.
Conducting comprehensive evaluations of educational resources utilized by nurses, clinical coordinators, laboratory personnel, and pharmacy staff constitutes a key responsibility.
Clinical assessments and interventions are conducted, with a focus on ensuring safety through continuous monitoring and accurate reporting.
Offer expert direction regarding clinical evaluations, interventions, and procedural steps as mandated by study protocols.
Quarterly evaluations of safety data, including Serious Unexpected Serious Adverse Reactions (Sugars) and Serious Adverse Events (SAE’s), as well as Investigator Brochures, are performed to examine trends and uncover areas requiring further training or development.
Responsible for supervising the tracking and documentation of adverse events and safety issues.
Maintain punctual and precise reporting to regulatory bodies and study sponsors.
We are seeking a dynamic leader to oversee and develop our team, ensuring high performance and professional growth. The ideal candidate will be responsible for mentoring staff, fostering a collaborative work environment, and aligning team objectives with organizational goals. Strong interpersonal and communication skills are essential, along with the ability to motivate and inspire cross-functional teams. Additionally, the role requires experience in talent development, performance management, and strategic workforce planning.
Deliver strategic direction and direct line management to research nurses, study coordinators, pharmacy staff, and laboratory personnel.
Plan and coordinate workforce distribution, talent acquisition, employee integration, and retention initiatives to guarantee appropriate staffing levels that align with study demands and organizational expansion.
Collaborate with AKU counterparts to establish consistency in roles and responsibilities.
Set measurable performance benchmarks and carry out periodic performance evaluations in accordance with institutional HR guidelines.
Conduct thorough assessments to determine staff training and professional development requirements, then implement targeted programs to address them.
Promote a culture characterized by ongoing quality enhancement and collaborative teamwork.
Quality Assurance professionals are responsible for ensuring product and service excellence through systematic evaluation and validation processes. They design, implement, and oversee training programs to enhance employee proficiency and operational efficiency. Additionally, they develop educational initiatives to promote compliance with industry standards and foster a culture of continuous improvement within the organization.
Oversee operational aspects of quality assurance protocols throughout Clinical Research Unit initiatives, guaranteeing adherence to rigorous clinical standards, data accuracy, and meticulous study documentation.
Perform regular quality assurance assessments and internal audits to verify the accuracy, completeness, and punctuality of clinical research documentation.
Develop and implement strategic initiatives to enhance capacity building and workforce development, ensuring alignment with both current and future research portfolios.
Spearhead the planning and development phases of Standard Operating Procedures (SOPs) for clinical research operations, while overseeing their review process.
Deliver comprehensive training and educational programs to clinical personnel regarding study protocols, Good Clinical Practice (GCP) guidelines, and pertinent operational procedures.
Remain informed about advancements in clinical research and share relevant insights with team members to ensure collective understanding and informed decision-making.
Conduct comprehensive evaluations of potential study projects to determine their viability, ensuring alignment with organizational objectives and feasibility criteria. Analyze key factors such as budget constraints, resource availability, regulatory compliance, and logistical requirements to assess whether proposed initiatives can be successfully executed. Prepare detailed reports summarizing findings, risks, and recommendations to support informed decision-making by stakeholders. Collaborate with cross-functional teams, including finance, legal, and operations, to gather necessary data and validate assumptions.
Collaborate with Investigators to evaluate emerging research and assess the feasibility of clinical trial protocols.
The role involves overseeing and controlling financial resources to ensure efficient allocation in alignment with organizational goals. Responsibilities include tracking expenditures, forecasting future needs, and maintaining accurate financial records. Additionally, the position requires analyzing budget variances, identifying cost-saving opportunities, and ensuring compliance with established financial policies and regulations. Proficiency in budgeting software and strong analytical skills are essential, along with the ability to communicate financial insights clearly to stakeholders. A minimum of three years of experience in budget management or a closely related field is required.
Assist in the creation and oversight of financial plans associated with clinical operations in research studies.
Oversee and regulate expenditures associated with clinical resources and services to ensure financial efficiency and accountability.
Participates actively in the formulation and implementation of strategic plans and provides direction for the CPU.
Provide dedicated assistance to the Cancer Center Director in developing and implementing strategic initiatives for the Clinical Research Unit (CPU).
From time to time, additional duties may be assigned as deemed necessary.
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, with a minimum of seven years of hands-on clinical experience, is required.
Proficiency in established clinical research standards (such as CITY training or equivalent) and demonstrated engagement with leading international organizations, including ABACI, CRY, SACRA, ACRE, or comparable entities, is required.
A current and valid Nursing Council of Kenya (NCK) license is required.
Advanced Cardiovascular Life Support certification is mandatory for this position.
Seeking a candidate with a proven track record in similar roles, equipped with the necessary skills and expertise to excel in this position. The ideal applicant should bring hands-on experience directly applicable to the responsibilities outlined, ensuring a seamless transition and immediate contribution to the team. Demonstrated success in comparable environments is essential, as the role demands proficiency in key tasks and the ability to adapt to industry-specific challenges.
With a minimum of seven years of experience in clinical research, candidates should have spent at least five of those years actively engaged in clinical trial activities.
Crafting and managing budgets with a high degree of proficiency is essential, requiring a thorough grasp of financial planning, resource allocation, and fiscal oversight.
Proficiency in collaborating with clinical, regulatory, laboratory, and pharmacy personnel is essential for the effective execution of clinical trials.
Individuals must possess a thorough understanding and hands-on experience with audit and/or accreditation procedures, particularly in the context of upholding best practices in standard of care and/or research environments.
Proficiency in Good Clinical Practice (GCP) guidelines, clinical trial protocols, nursing patient care standards, biomaterials handling procedures, and health safety regulations is required.
Proficiency in operating computers and utilizing standard office software, including Outlook, Microsoft Word, Excel, and PowerPoint, is required.
We are seeking an individual who demonstrates a strong sense of professionalism, adaptability, and integrity in their work. The ideal candidate will exhibit exceptional communication skills, both written and verbal, to effectively engage with colleagues, clients, and stakeholders. Strong problem-solving abilities and a proactive approach to challenges are essential for success in this role. Additionally, the candidate must possess the capacity to work independently while also collaborating seamlessly within a team environment. A commitment to continuous learning and personal development is highly valued, as is the ability to maintain a positive attitude under pressure. Professionalism, reliability, and a customer-centric mindset are non-negotiable traits for this position.
Demonstrated proficiency in fostering strong interpersonal relationships and conveying information effectively through both written and spoken communication channels.
Accomplished leadership and administrative capabilities are essential, along with a proven ability to guide teams, drive performance, and oversee operations effectively.
Demonstrates exceptional organizational skills, effectively managing a wide range of tasks across multiple studies and clinics concurrently.
Demonstrates professional maturity and the capacity to operate autonomously with minimal supervision. Exhibits reliability, sound judgment, and the discipline to manage responsibilities effectively without constant oversight.
The ability to adapt across diverse functions within healthcare is essential, including clinical and nursing care, patient services support, laboratory and biospecimen processing, as well as data management.
With the ability to work both independently and collaboratively, you will demonstrate proactive engagement in driving projects forward while contributing effectively within a team setting.
Demonstrated capacity to perform effectively under pressure while consistently meeting established deadlines.
Proven capability to thrive in diverse cultural settings, demonstrating adaptability and respect for varied perspectives and backgrounds.
Excellent verbal and written communication abilities are essential, enabling effective interaction with colleagues, clients, and stakeholders across diverse organizational levels.
Qualifications
BA/BSc/HND , MBA/MSc/MA
Experience Required
7 years
