Job Summary
The CPU Clinical Operations Manager (COM) oversees and directs the clinical operations of the research unit, providing leadership, coordinating efforts, and fostering collaboration across interdisciplinary teams to ensure the effective execution and management of clinical research studies. This role serves as the supervisory point of contact for all clinical personnel, including lab, pharmacy, and nursing staff.
Oversee a comprehensive range of duties that include managing daily operations, ensuring compliance with regulatory standards, coordinating team activities, and maintaining accurate records to support organizational objectives. This role demands strong analytical skills to assess performance metrics, identify trends, and propose strategic improvements to enhance productivity and efficiency. Additionally, the position requires effective communication abilities to liaise between departments, present reports to leadership, and facilitate cross-functional collaboration. Candidates must demonstrate proficiency in relevant software systems, meticulous attention to detail, and the capacity to adapt to evolving business needs while upholding high standards of professionalism and integrity.
Clinical trial oversight and development involve ensuring the integrity, safety, and compliance of clinical trials through meticulous monitoring and strategic planning. This role requires a deep understanding of regulatory guidelines, such as ICH-GCP, FDA, and EMA standards, alongside robust project management skills to coordinate cross-functional teams. Responsibilities include designing trial protocols, managing investigator sites, maintaining data accuracy, and mitigating risks to uphold ethical and scientific rigor. Strong communication and problem-solving abilities are essential to address challenges, ensure sponsor and site alignment, and deliver high-quality trial outcomes within specified timelines.
The Clinical Operations Manager (COM) for the CPU will oversee the daily clinical operations of the Clinical Research Unit.
Offer strategic leadership and direction to the clinical operations within the unit while ensuring oversight of the nursing, pharmacy, and laboratory aspects of clinical trials.
Responsible for coordinating the planning, commencement, and implementation of research studies in partnership with principal investigators/designees and study teams.
Responsibilities include managing the comprehensive clinical care of patients enrolled in clinical trials, encompassing screening, consent acquisition, sample collection, drug administration, continuous patient management, and preparation of end-of-study documentation, all while coordinating with relevant team members to ensure compliance and seamless execution.
Protocol implementation, adherence to regulatory standards, and maintenance of quality compliance represent critical components of this role.
Ensure strict compliance with study protocols, applicable regulatory requirements, and Good Clinical Practice (GCP) guidelines. Deliver necessary training to staff as required.
Collaborate with managers, investigators, and sponsors to execute the clinical components of study protocols and maintain adherence to regulatory standards.
Collaborate with AKU management and leadership teams to uphold adherence to institutional policies and JCI standards.
Conduct audits and inspections across all clinical trial components and Unit-related facets to ensure compliance and operational integrity.
Consistently enhanced quality metrics were evidenced by ongoing internal quality assessments and findings from monitoring visits.
Conducting thorough quality assessments of educational materials intended for nurses, clinical coordinators, laboratory technicians, and pharmacy personnel.
Clinical assessments and interventions, along with safety monitoring and reporting, are conducted to ensure the well-being of clients and adherence to established protocols. This role involves evaluating individuals’ needs, implementing appropriate care strategies, and continuously observing for any potential risks or concerns. Accurate documentation of observations and actions taken is essential to maintain compliance and facilitate ongoing care planning.
Offer expert recommendations regarding clinical evaluations, therapeutic actions, and protocol-specific procedures as outlined in study guidelines.
Quarterly, evaluate safety data, including Sugars, SAE’s, and Investigator Brochures, to detect trends and pinpoint areas for improvement in understanding and performance.
Responsible for managing the tracking and documentation of adverse events and safety concerns.
Proactively deliver precise and punctual reporting to regulatory bodies and study sponsors in accordance with established timelines and compliance standards.
We are seeking a dynamic leader with a proven ability to guide and develop high-performing teams. The ideal candidate will oversee staff management responsibilities, ensuring optimal performance, professional growth, and engagement. This role requires fostering a collaborative work environment, implementing effective training initiatives, and addressing team challenges with strategic solutions. Strong interpersonal skills, mentorship capabilities, and a commitment to nurturing talent are essential for success in this position.
Offer strategic direction and day-to-day supervision to research nurses, study coordinators, pharmacy personnel, and laboratory staff.
Oversee strategic workforce allocation, recruitment, onboarding, and retention initiatives to guarantee optimal staffing levels that align with study workload demands and unit expansion goals.
Collaborate with counterparts at AKU to maintain alignment in roles and responsibilities.
Set measurable performance goals and perform periodic evaluations aligned with the organization’s HR policies and procedures.
Assess and implement staff training and professional development requirements to enhance skills and performance.
Cultivate an environment that prioritizes ongoing quality enhancement and collaborative teamwork.
Quality Assurance responsibilities include developing, implementing, and monitoring training programs to ensure staff proficiency and regulatory compliance. This role requires delivering educational sessions to enhance team competencies and conducting thorough evaluations to assess training effectiveness. Additionally, the position involves maintaining up-to-date records of certification statuses and providing recommendations for continuous professional development to support organizational goals.
Offer comprehensive operational management of quality assurance protocols throughout all Clinical Research Unit operations, upholding stringent standards in clinical practice, data accuracy, and study documentation.
Perform systematic 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 to strengthen support for both existing and emerging research portfolios.
Spearhead the planning and development phases for Standard Operating Procedures (SOPs) in clinical research operations, ensuring thorough review and adherence to regulatory standards.
Deliver comprehensive training and educational programs to clinical staff regarding study protocols, Good Clinical Practice (GCP), and pertinent operational procedures.
Remain informed about advancements in clinical research and ensure the team receives the latest insights and findings.
Conduct thorough evaluations of project viability by analyzing technical, economic, operational, scheduling, and legal factors to determine feasibility and potential risks.
Collaborate with Investigators to evaluate emerging research and assess the feasibility of clinical trial protocols.
Overseeing and maintaining the allocated financial resources is a key responsibility, ensuring efficient allocation and utilization to meet organizational objectives. This encompasses meticulous planning, tracking expenditures, and analyzing variances to optimize budget performance. Proficiency in financial software and tools is essential, along with strong analytical skills to interpret data and provide actionable insights. Collaborating with department heads to align budgetary needs with strategic goals is also required, along with preparing comprehensive reports for stakeholders. Experience in budget forecasting and variance analysis is highly desirable.
Assist in the formulation and oversight of financial plans associated with clinical operations within trial settings.
Oversee and manage expenditures associated with clinical resources and services to ensure fiscal responsibility and alignment with budgetary constraints.
Responsible for contributing to the formulation of strategic plans and guiding the direction of the CPU, ensuring alignment with organizational objectives and fostering long-term growth.
Provide strategic assistance to the Director of the Cancer Center, focusing on the development and implementation of strategic plans for the Clinical Research Unit.
Diverse responsibilities may be periodically delegated as operational needs arise.
Applicants must hold a Bachelor’s degree in a relevant field, such as Computer Science, Engineering, or Business Administration, and possess at least three years of professional experience in a related sector. Proficiency in data analysis, project management, and software applications like Microsoft Office Suite is essential. Strong interpersonal and communication skills are required to collaborate effectively within cross-functional teams. Candidates should demonstrate a track record of problem-solving and an ability to work independently while meeting deadlines. Knowledge of industry regulations and best practices is also necessary.
A master’s degree in a health-related field—such as nursing, bioethics, clinical research, or public health—or a bachelor’s degree in a health-related discipline (e.g., nursing, laboratory science, pharmacy) with a minimum of seven years of hands-on clinical experience is required.
Proficiency in clinical research best practices, evidenced by certifications such as CITY or equivalent training, as well as engagement with international organizations like ABACI, CRY, SACRA, ACRE, or comparable entities is required.
Holds a current and valid Nursing Council of Kenya (NCK) license in good standing.
ACLS certification is a prerequisite for this position.
We are seeking a candidate with substantial practical experience within the specified field to fulfill this role effectively. The ideal applicant should bring a minimum of five years of hands-on experience in a closely related industry, demonstrating expertise through prior positions that align with the core responsibilities of this opportunity. Familiarity with industry-standard tools, methodologies, and best practices is essential, as is the ability to apply this knowledge to drive tangible results in a fast-paced environment. Additionally, the selected individual should possess strong problem-solving skills, exceptional attention to detail, and a proven track record of delivering high-quality outcomes in previous professional engagements.
With a minimum of seven years of professional experience in clinical research, including at least five years dedicated to active participation in clinical trials, candidates should meet this requirement.
Experts in budget development and management, with the ability to create and oversee comprehensive financial plans, are required. Proficiency in budget formulation, allocation, and monitoring is essential to ensure fiscal responsibility and alignment with organizational objectives.
Proficiency in collaborating with clinical, regulatory, laboratory, and pharmacy personnel is essential to ensure the effective execution of clinical trials.
Proficiency in conducting and contributing to audit and/or accreditation procedures, specifically concerning standard of care practices and research protocols, is required.
Proficient understanding of Good Clinical Practices (GCPs), clinical trial methodologies, nursing patient care protocols, biomaterials management, and health safety regulations is required.
Skilled in operating computers and utilizing essential office applications such as Outlook, Microsoft Word, Excel, and PowerPoint, among others.
Personal Characteristics & Behaviours
Proficient in both written and verbal communication, with a strong aptitude for interpersonal interactions.
Demonstrates exceptional capability in leading and managing teams or projects with a high degree of proficiency and effectiveness.
Demonstrates strong organizational skills with the capacity to effectively manage a wide range of responsibilities across multiple studies and clinics concurrently.
Demonstrates professional maturity and the capacity to operate autonomously in a structured or unstructured environment. Exhibits self-discipline, reliability, and the judgment required to make informed decisions without constant oversight. Functions effectively with minimal supervision while maintaining productivity, accountability, and the ability to prioritize tasks efficiently.
Capable of fulfilling diverse responsibilities across multiple domains, including clinical and nursing care, patient services support, laboratory and bio-specimen processing, as well as data management.
Demonstrates the ability to work independently while also contributing effectively within a collaborative team environment.
Proven capability to thrive under pressure while consistently delivering results within established deadlines.
Proven capability to thrive in diverse, multicultural work settings, demonstrating cultural awareness and adaptability to collaborate effectively with colleagues and stakeholders from varied backgrounds.
Demonstrates exceptional ability to communicate and collaborate effectively with colleagues, clients, and stakeholders across diverse backgrounds and situations.
Qualifications
BA/BSc/HND , MBA/MSc/MA
Experience Required
7 years
