Job Summary
The CPU Clinical Operations Manager (COM) oversees and directs the clinical operations of the research unit, providing leadership, coordination, and collaboration across interdisciplinary teams to ensure the effective execution of clinical research studies. This role is responsible for the supervision of all clinical personnel, including laboratory, pharmacy, and nursing staff, ensuring alignment with study objectives and regulatory standards.
Oversee daily operations to ensure seamless workflow and adherence to established protocols; manage a diverse team by assigning tasks, providing guidance, and evaluating performance to foster productivity and professional growth. Develop and implement strategic initiatives to enhance efficiency, reduce costs, and drive innovation within the department. Collaborate with cross-functional teams to align objectives, share insights, and resolve challenges. Uphold compliance with organizational policies, industry regulations, and quality standards while maintaining a safe and inclusive work environment. Analyze performance metrics, identify trends, and recommend improvements to optimize outcomes. Serve as a liaison between senior leadership and staff, communicating goals, expectations, and feedback with clarity and transparency.
Clinical trial oversight and development are essential components of ensuring the integrity, safety, and efficacy of medical research. This role involves meticulous planning, rigorous monitoring, and comprehensive evaluation of clinical trials to adhere to regulatory standards, ethical guidelines, and scientific protocols. Professionals in this field are responsible for designing study protocols, managing participant recruitment, tracking trial progress, and ensuring compliance with Good Clinical Practice (GCP) and other applicable regulations. Additionally, they collaborate with investigators, sponsors, and regulatory authorities to address challenges, mitigate risks, and maintain the highest standards of data quality and patient safety throughout the trial lifecycle.
The CPU Clinical Operations Manager (COM) will oversee all daily clinical operations within the Clinical Research Unit.
Provide visionary leadership and strategic guidance to the clinical operations of the unit while ensuring comprehensive oversight of nursing, pharmacy, and laboratory functions in clinical trial execution.
Responsible for managing the planning, initiation, and implementation of research studies in partnership with principal investigators or their designees and study teams.
Responsibilities include coordinating comprehensive clinical care for patients enrolled in clinical trials, encompassing screening, informed consent acquisition, specimen collection, medication administration, continuous patient management, and completion of end-of-study documentation, in collaboration with relevant team members.
Protocol development, adherence to regulatory standards, and maintenance of quality compliance are integral responsibilities.
Oversee the implementation of study protocols, regulatory standards, and Good Clinical Practice (GCP) guidelines to ensure full compliance. Deliver necessary training sessions for staff members to maintain competency and awareness of established procedures.
Partner with managers, investigators, and sponsors to execute and oversee the clinical components of study protocols while maintaining adherence to all regulatory standards.
Liaise with AKU managers and leadership to uphold institutional policies and meet JCI standards.
Conduct audits and inspections for all clinical trial components and the Unit’s associated elements.
Enhanced quality metrics were evidenced by consistent internal quality audits and findings from monitoring visits.
Ensuring the accuracy and effectiveness of educational resources utilized by nursing staff, clinical coordinators, laboratory personnel, and pharmacy professionals falls under the responsibility of conducting thorough quality reviews of study materials.
Clinical evaluations and therapeutic interventions are conducted, accompanied by ongoing safety oversight and comprehensive reporting.
Offer expert direction regarding clinical evaluations, therapeutic actions, and procedural steps as dictated by study protocols.
Every quarter, conduct a comprehensive review of safety data, including Suspected Unexpected Serious Adverse Reactions (Sugars), Serious Adverse Events (SAE’s), and Investigator Brochures, to evaluate trends and pinpoint areas requiring further education.
Responsibilities include ensuring the systematic monitoring and reporting of adverse events and safety concerns, with a focus on maintaining comprehensive oversight and documentation.
Ensure prompt and precise submission of reports to regulatory bodies and study sponsors.
Seasoned professional required to oversee and guide teams with strategic leadership and effective staff management skills. Responsible for cultivating a productive work environment, fostering team collaboration, and ensuring alignment with organizational goals. Must demonstrate strong decision-making abilities, conflict resolution expertise, and a commitment to professional development. Requires exceptional communication, motivational techniques, and the capacity to inspire high performance across all levels of the organization.
Demonstrate strong leadership and line management capabilities by overseeing research nurses, study coordinators, pharmacy personnel, and laboratory staff.
Oversee strategic workforce planning, recruitment initiatives, seamless onboarding processes, and effective retention strategies to ensure optimal staffing levels that align with study workloads and organizational expansion.
Collaborate with counterparts at AKU to maintain consistency in roles and responsibilities.
Create measurable performance targets and administer periodic evaluations in accordance with organizational HR guidelines.
Assess and implement staff training and professional development requirements to enhance team capabilities and performance.
Promote a culture characterized by ongoing quality enhancement and collaborative teamwork.
Quality Assurance professionals are responsible for ensuring adherence to established standards, developing and delivering training programs, and fostering a culture of continuous learning and improvement within the organization. They evaluate processes to identify discrepancies, implement corrective actions, and verify compliance through systematic testing and validation. Additionally, they design educational initiatives to enhance employee skills, facilitate knowledge transfer, and support organizational growth through targeted development initiatives.
Oversee operational quality assurance processes for all activities within the Clinical Research Unit, maintaining rigorous standards in clinical practice, data integrity, and study documentation.
Perform regular quality assurance reviews and internal audits to verify the precision, thoroughness, and punctuality of clinical research documentation.
Develop and implement strategic initiatives aimed at enhancing capacity and fostering workforce growth to align with both existing and upcoming research projects.
Oversee the planning and development phase, as well as the review of Standard Operating Procedures (SOPs) pertaining to clinical research operations.
Deliver comprehensive training and educational programs to clinical staff, focusing on study protocols, Good Clinical Practice (GCP), and pertinent operational procedures.
Remain current with advancements in clinical research and share relevant insights with the team.
Conduct thorough evaluations of feasibility to ensure proposed projects or initiatives align with organizational goals and operational constraints. Analyze key factors such as resource availability, budgetary considerations, regulatory compliance, and potential risks to determine the viability of each undertaking. Collaborate with cross-functional teams to gather relevant data, assess market conditions, and validate assumptions. Prepare detailed reports summarizing findings, recommendations, and proposed next steps for stakeholder review and decision-making.
Collaborate with Investigators to evaluate emerging research and assess the feasibility of clinical trial protocols.
Overseeing and controlling the company’s budget is a critical responsibility, requiring meticulous tracking of expenditures, forecasting financial needs, and ensuring adherence to allocated funds. This role demands a keen eye for detail, strong analytical abilities, and proficiency in financial software to generate accurate reports and identify cost-saving opportunities. Candidates must possess prior experience in budget administration, a solid grasp of accounting principles, and the capability to present financial insights to stakeholders. Effective communication and strategic planning are essential to align budgetary allocations with organizational objectives while maintaining fiscal responsibility.
Play a key role in the creation and oversight of budgets associated with clinical trial activities.
Oversee and regulate expenditures pertaining to clinical resources and services to ensure fiscal accountability and operational efficiency.
Participates actively in the formulation and execution of strategic initiatives and overall guidance for the CPU, ensuring alignment with organizational objectives and fostering sustainable growth.
Provide strategic support to the Director of the Cancer Center by contributing to the development and implementation of comprehensive strategic plans for the Cancer Research Unit.
From time to time, additional responsibilities may be assigned as needed.
Position demands prior experience in a comparable role, with at least three years of hands-on involvement in the field. Academic qualifications must include a degree in a relevant discipline or equivalent professional certifications. Strong analytical abilities are essential for evaluating complex data and deriving actionable insights. Proficiency in industry-standard software and tools is required, along with the capacity to adapt to evolving technological advancements. Excellent interpersonal and communication skills are necessary to collaborate effectively with cross-functional teams and stakeholders. A commitment to continuous learning and professional development is also expected.
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 discipline like nursing, laboratory science, or pharmacy, coupled with a minimum of seven years of hands-on clinical experience, is required.
Proficient in clinical research best practices, demonstrated through completion of CITY or equivalent training, with active engagement in esteemed international organizations such as ABACI, CRY, SACRA, ACRE, or comparable entities.
Must possess a current and valid Nursing Council of Kenya (NCK) license.
Advanced Cardiovascular Life Support certification is mandatory for this position.
Seeking candidates with demonstrated experience in roles that align with the position’s core requirements and responsibilities. Applicants should possess a proven track record in fields pertinent to the job’s objectives, ensuring they can effectively contribute from day one. A minimum of [X years] of professional experience in a related industry is expected, with a focus on developing and applying relevant skills to drive success. Ideal applicants will have hands-on expertise in key functions outlined in the job description, positioning them to make immediate, meaningful contributions to the team.
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 trials.
Demonstrates a comprehensive grasp of budget preparation and management, ensuring precise allocation and control of financial resources.
Proficiency in collaborating with clinical, regulatory, laboratory, and pharmacy personnel is essential to support the execution of clinical trials.
Candidates must possess practical experience and familiarity with conducting and engaging in audit and/or accreditation procedures, particularly in relation to standards of care practices and/or research.
Proficient understanding of Good Clinical Practices (GCPs), clinical trial methodologies, nursing patient care protocols, biomaterial handling procedures, and health and safety standards is required.
Strong working knowledge of computers and essential office applications, including Outlook, Microsoft Word, Excel, and PowerPoint, is required.
Highly motivated individuals with strong interpersonal skills and a proactive approach to problem-solving are sought for this role. Candidates must exhibit exceptional communication abilities, a collaborative mindset, and a commitment to delivering high-quality outcomes. The ideal professional will demonstrate adaptability in dynamic environments, a keen attention to detail, and the capacity to work both independently and as part of a team. Ethical integrity, accountability, and a customer-focused attitude are essential traits for success in this position.
You must possess outstanding interpersonal abilities along with strong written and verbal communication skills.
Accomplished in guiding teams and overseeing operations with exceptional leadership and organizational acumen.
Proven expertise in coordinating multiple projects and studies across various clinics, coupled with exceptional organizational skills, ensures efficient management of diverse tasks and responsibilities.
Able to demonstrate professional maturity and effectively manage tasks with minimal supervision.
Capable of fulfilling diverse responsibilities across multiple interrelated domains, including clinical and nursing care, patient services support, laboratory and biospecimen processing, as well as data management.
Demonstrates exceptional independence while collaborating effectively with team members.
Demonstrates strong capacity to perform effectively under pressure while consistently delivering results within established timeframes. Exhibits composure and problem-solving skills in fast-paced environments to ensure timely project completion.
Proven capability to thrive in diverse, multicultural work settings, demonstrating cultural sensitivity and adaptability in collaborative team environments across various backgrounds.
Excellent verbal and written communication abilities are essential, with a strong aptitude for fostering collaborative relationships and resolving interpersonal challenges effectively.
Qualifications
BA/BSc/HND , MBA/MSc/MA
Experience Required
7 years
