Job Summary
The Clinical Operations Manager (COM) in the CPU is tasked with directing and administering the clinical operations of the research unit, ensuring seamless execution and adherence to clinical research study protocols. This role demands strong leadership, strategic coordination, and effective collaboration across multidisciplinary teams to facilitate the successful initiation, management, and completion of clinical trials. Furthermore, all clinical staff—including lab technicians, pharmacy personnel, and nursing teams—report directly to this position.
Oversee and manage daily operations to ensure efficiency and adherence to established protocols, providing leadership and direction to team members. Develop and implement strategic plans to achieve departmental goals, monitoring progress and making adjustments as necessary to optimize performance. Collaborate with cross-functional teams to align efforts and drive cohesive project execution, fostering a culture of accountability and continuous improvement. Serve as a primary point of contact for internal and external stakeholders, addressing inquiries and resolving issues in a timely and professional manner. Maintain compliance with industry regulations and organizational policies, conducting regular audits and assessments to mitigate risks. Identify opportunities for innovation and process enhancements, recommending and implementing solutions that improve productivity and sustainability.
Clinical trials are monitored and developed to ensure adherence to protocols, regulatory standards, and ethical guidelines. This role involves overseeing trial activities, managing documentation, and coordinating with investigators, sponsors, and regulatory bodies to maintain compliance and data integrity. Responsibilities include reviewing trial designs, assessing risks, and implementing corrective actions as needed. Development efforts encompass refining protocols, enhancing operational efficiency, and aligning processes with evolving industry best practices. Strong communication, meticulous attention to detail, and a thorough understanding of Good Clinical Practice (GCP) and applicable regulations are essential for success in this position.
The Clinical Operations Manager (COM) for CPU will oversee the daily clinical operations of the Clinical Research Unit, ensuring seamless execution and adherence to established protocols.
Offer strategic leadership and direction to the clinical operations of the unit, with direct oversight of nursing, pharmacy, and laboratory functions in clinical trials.
Responsible for coordinating the planning, launch, and implementation of research studies in partnership with principal investigators or their delegates and study teams.
Responsibilities include managing comprehensive clinical care for patients participating in clinical trials, encompassing activities such as patient screening, informed consent procedures, specimen collection, medication administration, continuous patient monitoring, and finalizing study documentation in collaboration with relevant team members.
Protocol execution, adherence to regulatory standards, and maintaining quality compliance constitute essential responsibilities.
Ensure strict compliance with study protocols, regulatory mandates, and Good Clinical Practice (GCP) standards. Deliver necessary training to staff members as required.
Work collaboratively with managers, investigators, and sponsors to execute and oversee the clinical components of study protocols while ensuring adherence to regulatory standards.
Collaborate with AKU leadership and management to uphold institutional policies and meet JCI standards.
Conduct oversight of audits and inspections pertaining to all clinical trial components and Unit-related aspects.
Consistently enhanced quality metrics as evidenced by regular internal quality assessments and findings from monitoring visits.
Perform comprehensive quality assessments of educational materials and resources designed for nurses, clinical coordinators, laboratory personnel, and pharmacy staff.
Clinical assessments and interventions, as well as safety monitoring and reporting, are conducted with diligence and precision.
Offer expert recommendations regarding clinical evaluations, therapeutic actions, and procedural steps as dictated by study protocols.
Review safety data, including Sugars and SAE’s, as well as Investigator Brochures, on a quarterly basis to assess trends and pinpoint areas for improvement.
Responsible for supervising the tracking and documentation of adverse events and safety concerns.
Accurate and timely reporting to regulatory authorities and study sponsors must be consistently maintained.
Seasoned professionals with a proven track record in leadership and staff management are sought after to oversee teams and drive organizational success. Responsibilities include guiding employees, fostering professional growth, and ensuring optimal team performance through clear communication and strategic direction. Ideal candidates will have exceptional interpersonal skills, a strong ability to motivate others, and experience in conflict resolution and decision-making. Proficiency in performance management, talent development, and fostering a positive work environment is essential.
Offer strategic direction and day-to-day supervision to research nurses, study coordinators, pharmacy staff, and laboratory personnel.
Plan and direct workforce allocation, recruitment, onboarding, and retention initiatives to guarantee appropriate staffing levels that align with study demands and unit expansion.
Collaborate with AKU counterparts to maintain consistency in roles and responsibilities.
Develop well-defined performance benchmarks and administer consistent performance evaluations in accordance with established organizational HR guidelines.
Conduct a comprehensive assessment to determine staff training and professional development requirements, then implement tailored programs to address those needs.
Cultivate an environment that consistently enhances quality and encourages collaborative efforts among team members.
Quality Assurance encompasses the development, implementation, and oversight of processes to ensure products or services meet established standards. This role also involves designing and delivering training programs to enhance employee skills and knowledge, as well as providing ongoing education to support professional growth and compliance with industry regulations.
Oversee quality assurance operations for all Clinical Research Unit activities to maintain rigorous standards in clinical practice, data integrity, and study documentation.
Perform systematic quality assurance 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, ensuring alignment with present and upcoming research portfolios.
Spearhead the development and review of Standard Operating Procedures (SOPs) for clinical research operations to ensure alignment with regulatory standards and organizational objectives.
Deliver comprehensive training and educational sessions to clinical staff, focusing on study protocols, Good Clinical Practice (GCP), and pertinent procedural guidelines.
To ensure the team remains informed about advancements in clinical research, disseminate relevant findings and developments on a regular basis.
Conduct thorough evaluations of feasibility to identify potential challenges and opportunities within proposed projects, ensuring all pertinent factors are meticulously analyzed.
Alongside Investigators, conduct feasibility assessments and review clinical trial protocols by evaluating new studies to determine their suitability and viability.
Overseeing financial resources is a key responsibility, requiring meticulous planning, allocation, and monitoring of the allocated budget to ensure optimal use of funds. This role demands proficiency in financial analysis, forecasting, and expense tracking to maintain fiscal discipline. Candidates must possess strong analytical skills, attention to detail, and experience in budget preparation and variance analysis. Collaboration with stakeholders is essential to align budgetary goals with organizational objectives while adhering to regulatory and compliance standards.
Play a key role in creating, overseeing, and maintaining budgets specifically for clinical trial operations and activities.
Oversee and regulate expenditures associated with clinical resources and services to ensure efficient allocation and adherence to budgetary constraints.
Facilitates active participation in the formulation and execution of strategic initiatives and guidance for the Customer Relations Unit (CPU), ensuring alignment with organizational objectives and operational priorities.
Provide strategic support to the Director of the Cancer Center by contributing to the planning and development of CPU initiatives.
Assigned tasks may vary periodically as needed to support operational objectives.
We seek a candidate with a robust academic background in a relevant technical or scientific discipline, complemented by several years of hands-on experience in the field. Essential qualifications include proficiency in industry-standard software tools and methodologies, as well as strong analytical, problem-solving, and communication abilities. The ideal candidate will demonstrate a track record of delivering high-quality projects within stipulated timelines, while adhering to regulatory and ethical standards. Additionally, familiarity with emerging technologies or specialized certifications is highly desirable.
A master’s degree in a health-related field such as nursing, bioethics, clinical research, or public health is required; alternatively, a bachelor’s degree in a health discipline (e.g., nursing, laboratory science, pharmacy) with a minimum of seven years of hands-on clinical experience is acceptable.
Proficiency in clinical research best practices, evidenced by completion of recognized training programs like CITY, along with engagement in international organizations such as ABACI, CRY, SACRA, ACRE, or equivalent entities, is required.
Must possess a current and valid Nursing Council of Kenya (NCK) license in good standing.
Advanced Cardiovascular Life Support (ACLS) certification is a mandatory prerequisite for this role.
Seeking candidates with a proven track record in roles directly aligned with the responsibilities of this position. Demonstrated expertise in [specific skills or areas, if applicable] is essential, as is familiarity with [industry-specific tools, regulations, or processes]. Previous engagement in [type of projects, industries, or tasks] is highly desirable, ensuring a seamless transition into the position. Applicants should possess [X years] of hands-on experience in [relevant field or function], with a strong ability to [key skill or competency].
With a minimum of seven years of professional experience in clinical research, including at least five years dedicated to the execution of clinical trials, you will bring a robust background to this role.
Demonstrates advanced proficiency in budget development and management, ensuring accurate financial planning and resource allocation.
Experienced in collaborating with clinical, regulatory, laboratory, and pharmacy personnel to facilitate the execution of clinical trials.
Proficiency in navigating and engaging in audit and/or accreditation procedures, particularly in the context of care standards and/or research, is essential.
Proficient understanding of Good Clinical Practices (GCPs), clinical trial methodologies, nursing patient care standards, biomaterials handling protocols, and health safety regulations is required.
Demonstrates strong computer literacy and adeptness with essential office productivity tools, including Outlook, Microsoft Word, Excel, and PowerPoint, among others.
We are seeking a candidate who embodies strong personal attributes and professional conduct. The ideal individual should demonstrate integrity, adaptability, and a collaborative mindset in all interactions. Proven ability to manage time efficiently, prioritize tasks, and maintain composure under pressure is essential. Self-motivation, strong problem-solving skills, and a commitment to continuous improvement are highly valued. Exceptional communication and interpersonal skills are required to foster positive relationships with colleagues and stakeholders. The role demands a proactive approach, a willingness to take initiative, and the capacity to work both independently and as part of a team.
Proven ability to establish strong working relationships through clear and effective communication, both in writing and verbally, is essential.
Exceptional ability to lead and manage teams effectively.
Highly proficient in managing multiple studies and clinics concurrently, along with exceptional organizational skills to coordinate a variety of tasks efficiently.
Displaying a high level of professionalism and self-motivation, the ideal candidate must demonstrate the capacity to operate autonomously while maintaining focus on assigned tasks and responsibilities. Strong time management skills and a proactive approach are essential to ensure productivity and meet deadlines without constant oversight.
Proven ability to adapt seamlessly across diverse functional areas, including direct clinical and nursing care delivery, patient services coordination, laboratory and biospecimen processing operations, as well as comprehensive data management responsibilities.
Maintains a proactive approach to work while effectively collaborating within a team setting.
Ability to handle stressful situations and meet deadlines
Proven capability to thrive in diverse, multicultural settings, fostering collaboration and effectiveness across varied cultural perspectives.
Proven ability to collaborate effectively with diverse teams, foster strong professional relationships, and communicate with clarity and diplomacy in high-pressure environments. Demonstrates emotional intelligence, active listening, and adaptability to meet the needs of stakeholders across various levels of an organization.
Qualifications
BA/BSc/HND , MBA/MSc/MA
Experience Required
7 years
