Job Summary
The CPU Clinical Operations Manager (COM) provides leadership and oversight for the clinical operations of the research unit, ensuring the efficient execution and management of clinical research studies. This role involves coordinating and collaborating with cross-functional teams to facilitate seamless study implementation and conduct. All clinical personnel, including lab, pharmacy, and nursing staff, report directly to this position.
Oversee a range of essential duties, including managing project timelines, coordinating team efforts, and ensuring adherence to company standards. Collaborate closely with stakeholders to identify objectives and develop actionable plans to achieve them efficiently. Monitor progress regularly, address any obstacles promptly, and maintain clear communication to ensure all deliverables meet quality and deadline requirements. Prepare detailed reports to track performance metrics and provide insights for continuous improvement. Foster a productive work environment by delegating tasks effectively and supporting team members in overcoming challenges.
Clinical trial oversight and development encompass the comprehensive management and strategic advancement of clinical trials to ensure adherence to regulatory standards, ethical guidelines, and scientific integrity. This role involves meticulous planning, coordination, and execution of trial protocols while maintaining strict compliance with Good Clinical Practice (GCP) and applicable regulatory frameworks. Responsibilities include designing trial methodologies, overseeing participant recruitment and retention, monitoring data collection and analysis, and ensuring timely reporting of findings. Additionally, the position requires collaboration with cross-functional teams, including investigators, sponsors, and regulatory authorities, to facilitate seamless trial progression and address any operational or compliance challenges that may arise.
The Clinical Operations Manager (COM) at CPU will oversee the daily clinical operations of the Clinical Research Unit, ensuring seamless execution and adherence to established protocols.
Provide strategic leadership and direction for the clinical aspects of the unit while managing the nursing, pharmacy, and laboratory functions integral to clinical trials.
You will coordinate the planning, launch, and implementation of research studies in partnership with principal investigators, their designees, and study teams.
Responsibilities include managing comprehensive clinical care for patients enrolled in clinical trials, encompassing screening, informed consent, sample collection, medication administration, continuous care throughout the trial, and final documentation—all in coordination with relevant team members.
Protocol development, adherence to regulatory standards, and maintenance of quality compliance are required for this position.
Ensure strict compliance with study protocols, regulatory mandates, and Good Clinical Practice (GCP) standards. Deliver necessary training to staff as required.
Work closely with managers, investigators, and sponsors to execute and oversee the clinical components of study protocols while maintaining adherence to regulatory standards.
Collaborate with AKU management and leadership teams to uphold adherence to institutional policies and JCI standards.
Conduct audits and inspections for all components associated with the clinical aspects of trials and the Unit.
Routine internal quality audits and monitoring visit reports consistently reflect enhanced quality metrics.
Conducting thorough evaluations of educational resources for nursing, coordination, laboratory, and pharmacy personnel to ensure accuracy and effectiveness.
Clinical assessments and interventions are conducted, with a focus on ensuring safety through vigilant monitoring and accurate reporting.
Offer expert direction regarding clinical evaluations, therapeutic actions, and procedural steps as mandated by study protocols.
Conduct a quarterly review of safety data, such as Sugars, SAE’s, and Investigator Brochures, to assess trends and determine areas for improvement in learning.
Responsibilities include supervising the tracking and documentation of adverse events and safety concerns.
Prepare and submit all required reports to regulatory bodies and study sponsors promptly and with precision.
Experienced professionals sought to oversee and guide teams with excellence. The role demands strong leadership capabilities to inspire, motivate, and develop staff while ensuring high performance and productivity. Responsibilities include strategic planning, delegating tasks, providing constructive feedback, and fostering a collaborative work environment. Candidates must demonstrate exceptional communication skills, emotional intelligence, and a proven track record in team management. Proficiency in conflict resolution, decision-making, and talent development is essential to drive organizational success.
Demonstrate leadership and line management expertise by overseeing research nurses, study coordinators, pharmacy staff, and laboratory personnel.
To strategically manage workforce allocation, recruitment, onboarding, and retention efforts, ensuring optimal staffing levels that align with study workloads and organizational expansion objectives.
Collaborate with colleagues at AKU to maintain consistency in duties and accountabilities.
Set measurable performance goals and perform periodic performance evaluations aligned with established HR policies.
Assess and implement staff training and professional development requirements.
Cultivate an environment characterized by relentless pursuit of quality enhancement and collaborative synergy among team members.
Quality Assurance encompasses the development and implementation of rigorous testing protocols to verify product integrity, reliability, and compliance with established standards. In addition to these core responsibilities, the role involves designing and delivering comprehensive training programs tailored to enhance employee competency and operational efficiency. Furthermore, the position requires fostering an environment of continuous learning through educational initiatives aimed at promoting industry best practices and ensuring adherence to regulatory requirements.
Oversee operational quality assurance processes for all activities within the Clinical Research Unit to maintain 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.
Develop and execute strategic plans to enhance capacity building and workforce development, ensuring alignment with both current and future research initiatives.
Oversee the development and review of Standard Operating Procedures (SOPs) for clinical research operations, ensuring alignment with regulatory standards and operational excellence.
Conduct educational sessions and training programs for clinical staff to ensure familiarity with study protocols, Good Clinical Practice (GCP), and pertinent procedural guidelines.
Remain informed about advancements in clinical research and share relevant insights with team members to ensure collective awareness and informed decision-making.
Conduct comprehensive evaluations to determine the viability of proposed projects, analyzing key factors such as market demand, resource availability, technical feasibility, and financial projections. Identify potential risks and opportunities, ensuring alignment with strategic objectives and organizational goals. Prepare detailed reports summarizing findings, recommendations, and actionable insights to guide decision-making processes. Collaborate with cross-functional teams, including finance, operations, and legal departments, to gather necessary data and validate assumptions. Possess strong analytical skills, attention to detail, and proficiency in relevant software tools to support accurate and efficient assessments.
Collaborate with Investigators to evaluate emerging research and appraise clinical trial protocols through feasibility assessments.
Oversee financial planning, allocation, and monitoring of the allocated budget to ensure efficient use of resources and alignment with organizational objectives. Develop and maintain detailed budget reports, tracking expenditures against projections to identify variances and implement corrective actions when necessary. Collaborate with department heads to forecast future financial needs and optimize budget utilization. Ensure compliance with financial regulations and internal policies while providing strategic recommendations to enhance cost efficiency and operational effectiveness.
Assist in formulating and overseeing budgets associated with clinical trial operations to ensure financial efficiency and alignment with program objectives.
Oversee and manage the financial aspects of clinical resources and services to ensure efficient and effective utilization.
Involvement in strategic planning and direction of the CRU
Provide strategic support to the Director of the Cancer Center by contributing to the development and implementation of comprehensive CPU (Clinical Research Unit) plans and initiatives.
From time to time, additional responsibilities may be assigned as required.
Requirements
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 (e.g., nursing, laboratory science, pharmacy) coupled with a minimum of seven years of direct clinical experience is required.
Familiarity with established clinical research standards, validated through certifications such as CITY or equivalent training programs, is essential. Additionally, demonstrated engagement with internationally recognized professional bodies, including but not limited to ABACI, CRY, SACRA, ACRE, or their counterparts, is required.
Holds a current and valid Nursing Council of Kenya (NCK) license in good standing.
Advanced Cardiovascular Life Support (ACLS) certification is a mandatory qualification for this position.
Relevant Experience
With a minimum of seven years of professional experience in clinical research, including at least five years dedicated specifically to clinical trials, you will bring a strong foundation to this role.
Accomplished professionals with exceptional proficiency in budget development and management are sought after.
With expertise in interfacing with clinical, regulatory, laboratory, and pharmacy personnel, this role focuses on the effective implementation of clinical trials.
Proficiency in both conducting and contributing to audit and accreditation procedures, particularly concerning standards of care and/or research protocols, is essential.
Demonstrates a solid understanding of Good Clinical Practices (GCPs), clinical trial methodologies, nursing patient care protocols, biomaterials handling techniques, and health safety regulations.
Computers and essential office software, including Outlook, Microsoft Word, Excel, and PowerPoint, must be operated proficiently.
Personal Characteristics & Behaviours
Proven ability to communicate effectively in both spoken and written formats, coupled with exceptional interpersonal skills, is essential.
Demonstrates exceptional capability in leading and managing teams effectively, fostering a productive and collaborative work environment. Exhibits strong decision-making abilities and strategic planning to drive organizational success and team performance. Proven track record in managing resources, delegating tasks, and ensuring team alignment with company objectives.
Outstanding organizational skills are essential, enabling the effective management of various tasks across multiple studies and clinics with precision and efficiency.
Demonstrates a high level of professional maturity and the capacity to operate effectively with minimal supervision. Exhibits reliability, sound judgment, and the discipline necessary to manage tasks and deadlines without constant oversight.
Able to adapt seamlessly to diverse responsibilities within the healthcare environment, including direct clinical and nursing care, patient services support, laboratory and bio-specimen processing, as well as data management.
Demonstrated ability to work both independently and collaboratively within a team setting, showing a proactive approach to tasks and responsibilities.
Ability to handle stressful situations and meet deadlines
Proven capacity to thrive in diverse, multicultural settings, demonstrating cultural sensitivity and adaptability while fostering inclusive collaboration.
Proven ability to collaborate effectively with diverse teams, fostering strong professional relationships through clear communication and active listening. Demonstrated capacity to navigate interpersonal dynamics with professionalism, ensuring productive interactions and mutual respect in all professional settings.
Qualifications
BA/BSc/HND , MBA/MSc/MA
Experience Required
7 years
