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 facilitate the effective execution of clinical research studies. This role also serves as the supervisory point of contact for all clinical personnel, including lab, pharmacy, and nursing staff.
We are seeking a highly organized and detail-oriented individual to oversee daily operations, ensuring all tasks are completed accurately and efficiently. This role will involve managing multiple projects simultaneously, coordinating with various teams, and maintaining strict adherence to deadlines. Key duties include preparing and reviewing reports, implementing process improvements, and providing exceptional administrative support to senior leadership. The ideal candidate must possess strong communication skills, proficiency in industry-standard software, and the ability to thrive in a fast-paced environment.
Clinical trial oversight and development involve ensuring compliance with regulatory standards and maintaining the integrity of research protocols. This role requires meticulous attention to detail, strong organizational skills, and the ability to manage multiple concurrent projects. Responsibilities include designing and implementing clinical trial strategies, coordinating with investigators, and monitoring progress to ensure timely and accurate data collection. Additionally, the position demands a deep understanding of Good Clinical Practice (GCP) guidelines and the capacity to address any deviations or challenges that may arise during the trial process.
The CPU Clinical Operations Manager (COM) will oversee and manage the ongoing clinical operations of the Clinical Research Unit on a daily basis.
Deliver strategic leadership and direction for the clinical operations within the unit while ensuring robust oversight of nursing, pharmacy, and laboratory functions integral to clinical trial execution.
Responsibilities include managing the planning, launching, and implementation of research studies in partnership with principal investigators or their authorized representatives, as well as the broader study teams.
Responsibilities include managing the full scope of clinical trial patient care, encompassing patient screening, informed consent procedures, specimen collection, medication administration, continuous patient management, and completion of end-of-study documentation, in coordination with relevant team members.
Protocol development, adherence to regulatory frameworks, and maintenance of quality compliance standards are essential responsibilities.
Ensure strict compliance with study protocols, regulatory mandates, and Good Clinical Practice (GCP) guidelines. Deliver necessary training to staff as required.
Work in conjunction with managers, investigators, and sponsors to execute and oversee the clinical components of study protocols while maintaining adherence to regulatory standards.
Collaborate with AKU leadership and management teams to uphold institutional policies and meet JCI compliance standards.
Conduct comprehensive audits and inspections covering all clinical trial components and unit-related aspects to ensure compliance and operational excellence.
Improved quality metrics demonstrated through routine internal quality checks and monitoring visit reports.
Responsible for conducting thorough evaluations of educational resources intended for nurses, clinical coordinators, laboratory personnel, and pharmacy staff.
Conduct clinical evaluations and implement appropriate treatments, while ensuring continuous safety monitoring and reporting throughout the process.
Offer expert direction regarding clinical evaluations, treatments, and methodologies mandated by study protocols.
Conduct quarterly evaluations of safety data, including Suspected Unexpected Serious Adverse Reactions (Sugars), Serious Adverse Events (SAE’s), and Investigator Brochures, to assess emerging trends and pinpoint areas requiring further education and improvement.
Responsible for supervising the tracking and documentation of adverse events and safety issues.
Ensure regulatory authorities and study sponsors receive precise and punctual reports.
We are seeking a dynamic leader to oversee and guide our team, ensuring optimal performance and professional growth for all staff members. The ideal candidate will be responsible for cultivating a positive work environment, delegating tasks effectively, and fostering collaboration across departments. Key duties include mentoring employees, conducting performance evaluations, and developing strategies to enhance productivity and engagement. Proficiency in conflict resolution, strategic planning, and interpersonal communication is essential. A minimum of five years of experience in team leadership or management is required, along with a proven track record in driving team success and individual development.
Offer strategic direction and direct line management to research nurses, study coordinators, pharmacy staff, and laboratory personnel.
Develop and direct strategies for staffing, including recruitment, hiring, and retention initiatives, to ensure optimal team sizing in alignment with study demands and organizational expansion.
Collaborate with AKU counterparts to maintain consistent role and responsibility alignment.
Develop precise performance benchmarks and perform consistent evaluations in accordance with organizational HR regulations to ensure alignment with institutional standards.
Assess and address the training and professional development requirements of the staff.
Promote an environment characterized by ongoing quality enhancement and collaborative synergy among team members.
Quality Assurance responsibilities include verifying processes and procedures to ensure compliance with established standards. Training and education efforts focus on developing staff competency through structured programs and ongoing professional development opportunities. This role requires a keen attention to detail to identify discrepancies and implement corrective measures effectively. Additionally, the position demands strong communication skills to deliver training sessions and mentor team members, fostering a culture of continuous improvement and operational excellence.
Ensure operational oversight of quality assurance processes for all Clinical Research Unit activities, maintaining stringent standards in clinical practice, data integrity, and study documentation.
Perform systematic quality assurance reviews and internal audits to verify the precision, thoroughness, and punctuality of clinical research documentation.
Deliver strategic guidance to strengthen capacity-building initiatives and workforce development efforts, ensuring alignment with both present and emerging research portfolios.
Spearhead the strategic planning and development initiatives for Standard Operating Procedures (SOPs) in clinical research operations, ensuring thorough review and alignment with regulatory standards.
Offer comprehensive training and educational programs to clinical staff, focusing on study protocols, Good Clinical Practice (GCP), and pertinent procedural guidelines.
Remain informed about advancements in clinical research and ensure relevant information is shared with the team in a timely manner.
Conduct detailed evaluations of feasibility to determine the viability of proposed projects, ensuring all relevant factors—technical, financial, and operational—are thoroughly examined. Analyze market conditions, regulatory requirements, and potential risks to provide a comprehensive assessment that informs strategic decision-making. Collaborate with cross-functional teams to gather data, validate assumptions, and refine projections. Present findings in clear, actionable reports that highlight key insights and recommendations for stakeholders.
Collaborate with Investigators to assess the viability of new studies and examine clinical trial protocols through comprehensive feasibility evaluations.
Overseeing financial resources with precision and accountability, this role involves meticulous planning, allocation, and monitoring of organizational funds to ensure optimal utilization and adherence to fiscal policies. Duties include developing comprehensive budgets, forecasting financial needs, and implementing cost-control measures while maintaining transparency in all transactions. The position requires a keen analytical mindset, strong attention to detail, and proficiency in financial software to generate accurate reports and insights. Candidates must demonstrate experience in budget administration, compliance with regulatory standards, and the ability to collaborate across departments to align financial strategies with broader organizational objectives.
Assist in the formulation and oversight of financial plans associated with clinical operations within clinical trials.
Oversee and regulate expenditures associated with clinical resources and services to ensure fiscal responsibility and alignment with organizational objectives.
Participates in the formulation and execution of strategic plans and provides leadership for the CPU’s direction.
Provide strategic assistance to the Cancer Center Director in developing and implementing comprehensive planning initiatives for the Clinical Research Unit (CPU).
Duties may also include additional tasks as assigned from time to time.
We seek candidates who possess a bachelor’s degree in a relevant field, along with a minimum of three years of professional experience in a comparable role. Proficiency in industry-standard software and tools is essential, as is the ability to communicate clearly and collaborate effectively within a team. Strong problem-solving skills and a proactive approach to challenges are also required. Additionally, familiarity with regulatory compliance and best practices in the field is highly desirable.
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 (for example, nursing, laboratory sciences, or pharmacy) along with a minimum of seven years of hands-on clinical experience is required.
Proficiency in clinical research best practices is required, as evidenced by completion of CITY or equivalent training, along with active involvement in recognized international organizations such as ABACI, CRY, SACRA, ACRE, or comparable entities.
Holds a current and active Nursing Council of Kenya (NCK) license.
Advanced Cardiovascular Life Support (ACLS) certification is a mandatory qualification for this role.
We seek a candidate with substantial hands-on experience in a closely related field to this role. The ideal applicant will have a proven track record of successfully performing duties aligned with the core responsibilities of this position. Prior engagement in similar professional settings, demonstrating relevant competencies and achievements, is highly valued. A minimum of [X] years of direct experience in this domain is required, ensuring the individual possesses the necessary expertise to excel.
With a minimum of seven years of professional experience in clinical research, candidates must have dedicated at least five of those years to hands-on involvement in clinical trials.
A strong proficiency in budget development and management is required, along with the ability to create and oversee comprehensive financial plans.
Proven expertise in collaborating with clinical, regulatory, laboratory, and pharmacy professionals to facilitate the seamless execution of clinical trials.
Candidates should possess practical expertise and hands-on involvement in conducting and supporting audit and/or accreditation procedures, specifically within the context of care standards and/or research activities.
Proficient understanding of Good Clinical Practices (GCPs), clinical trial methodologies, nursing patient care protocols, biomaterials management, and health safety regulations is required.
Proven ability to proficiently operate computers and utilize essential office software, including Outlook, Microsoft Word, Excel, PowerPoint, and related applications.
Personal Characteristics & Behaviours
We demonstrate exceptional proficiency in cultivating strong interpersonal relationships and delivering clear, concise written and verbal communication.
Demonstrated expertise in guiding and overseeing teams, coupled with the ability to inspire and direct personnel toward achieving organizational goals. Proven capability to develop strategies, allocate resources efficiently, and foster a productive work environment through effective delegation and decision-making.
Possesses strong organizational skills and the capacity to manage a variety of tasks across multiple studies and clinics efficiently.
Demonstrates a high level of professionalism, self-motivation, and the capacity to manage responsibilities effectively without constant supervision. Exhibits sound judgment and reliability in decision-making, ensuring tasks are completed efficiently and to the highest standards.
Proven ability to adapt seamlessly across multiple disciplines, including clinical and nursing care, patient services support, laboratory and biospecimen processing, as well as data management.
Demonstrates proactive self-motivation while collaborating effectively within a team environment.
Demonstrates resilience in high-pressure environments and consistently delivers work within established timelines.
Proven capability to thrive in diverse, multicultural settings, collaborating effectively with colleagues from various backgrounds to achieve common objectives.
Demonstrates exceptional ability to communicate, collaborate, and build rapport with colleagues, clients, and stakeholders across diverse settings. Thrives in team-oriented environments while fostering positive relationships through active listening and clear, professional communication.
Qualifications
BA/BSc/HND , MBA/MSc/MA
Experience Required
7 years
