What Clinical Trial Manager Jobs are in Kenya?
Showing 404 Clinical Trial Manager jobs in Kenya
Job Description
- Lead and manage all aspects of clinical trial execution from initiation through to study close-out.
- Develop and maintain detailed clinical trial management plans, including timelines, budgets, and resource allocation.
- Select, oversee, and manage relationships with third-party vendors, including Contract Research Organizations (CROs), central labs, and IRBs/ECs.
- Ensure compliance with all applicable regulatory requirements (e.g., ICH-GCP, FDA, EMA) and internal SOPs.
- Oversee the recruitment and training of clinical site staff, ensuring effective protocol implementation.
- Monitor trial progress, identify potential risks and issues, and implement proactive mitigation strategies.
- Manage the clinical trial budget, track expenses, and ensure adherence to financial projections.
- Liaise with internal departments, including regulatory affairs, data management, biostatistics, and pharmacovigilance, to ensure seamless trial operations.
- Review and approve key study documents, such as protocols, investigator brochures, monitoring reports, and clinical study reports (CSRs).
- Ensure accurate and timely collection, review, and archiving of all trial-related documentation.
- Bachelor's degree in a life science, healthcare, or related field. Advanced degree (Masters, PhD, PharmD) is a plus.
- Minimum of 6 years of progressive experience in clinical trial management within the pharmaceutical or biotech industry.
- Demonstrated experience managing complex, multi-center, international clinical trials.
- In-depth knowledge of ICH-GCP guidelines, regulatory agency requirements, and clinical trial processes.
- Strong project management skills, including proficiency with project management software.
- Experience with vendor management and budget oversight.
- Excellent leadership, communication, and interpersonal skills.
- Ability to work effectively in a hybrid environment, balancing remote and in-office work.
- Proficiency in EDC, CTMS, and other clinical trial management systems.
- Strong analytical and problem-solving abilities.
- Willingness to travel up to 25% as needed for site visits and team meetings.
- Competitive salary package based on experience and qualifications.
- Comprehensive health, dental, and vision insurance.
- Retirement savings plan with company match.
- Generous paid time off and company holidays.
- Opportunities for professional development and continued education.
- Access to innovative research and development projects.
- Collaborative and supportive team environment.
- Hybrid work flexibility to promote work-life balance.
- Performance-based bonuses and incentives.
- Relocation assistance may be available for exceptional candidates.
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Job Description
Our client, a pioneering pharmaceutical company dedicated to advancing global health, is seeking an experienced and highly organized Senior Clinical Trial Manager to join their fully remote operations team. This role is critical in overseeing the planning, execution, and monitoring of complex clinical trials. As a remote-first organization, we are committed to fostering a connected and collaborative work environment, leveraging advanced digital tools to ensure seamless project management and communication across dispersed teams. You will be instrumental in ensuring that our clinical trials are conducted ethically, efficiently, and in full compliance with regulatory requirements. This position offers a significant opportunity to impact the development of life-saving therapies.
Key Responsibilities- Oversee all aspects of clinical trial management, from protocol development and site selection to data analysis and reporting.
- Develop and manage clinical trial budgets, timelines, and resource allocation.
- Ensure adherence to Good Clinical Practice (GCP) guidelines, FDA regulations, and other relevant regulatory requirements.
- Select, train, and manage clinical trial sites and investigators.
- Monitor trial progress, identify risks and issues, and implement corrective and preventive actions.
- Oversee the work of Clinical Research Associates (CRAs) and other study personnel.
- Liaise with regulatory authorities, ethics committees, and other external stakeholders.
- Ensure the timely collection, management, and quality assurance of clinical trial data.
- Prepare and review essential study documents, including protocols, informed consent forms, and study reports.
- Collaborate with cross-functional teams, including data management, biostatistics, and regulatory affairs.
- Manage vendor relationships, including CROs and central laboratories.
- Contribute to the continuous improvement of clinical trial processes and best practices within the organization.
- Champion a culture of ethical conduct, scientific integrity, and patient safety throughout all trial activities.
- Bachelor's degree in a scientific or healthcare-related field; a Master's degree or higher is preferred.
- Minimum of 6 years of progressive experience in clinical trial management within the pharmaceutical or biotechnology industry.
- Extensive knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trials.
- Proven experience in managing multiple complex clinical trials simultaneously.
- Strong leadership, project management, and organizational skills.
- Excellent communication, interpersonal, and problem-solving abilities, crucial for a remote environment.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to work independently, manage priorities effectively, and meet strict deadlines in a remote setting.
- Experience with various therapeutic areas is an asset.
- Demonstrated ability to build and maintain strong relationships with investigators and site staff.
- A proactive approach to identifying and mitigating risks.
Our client offers a highly competitive salary, a comprehensive benefits package including medical, dental, and vision insurance, life insurance, and a generous retirement savings plan. As a fully remote position, you will benefit from unparalleled flexibility and work-life balance. Professional development opportunities, including specialized training and conference participation, are readily available. We provide a technology stipend to ensure you have the best tools for your home office. Join our innovative team and play a vital role in bringing life-changing treatments to patients worldwide. This is an opportunity to grow your career with a leading pharmaceutical organization.
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Job Description
Our client, a rapidly growing Contract Research Organization (CRO) focused on advancing innovative therapies, is seeking an experienced and highly organized Clinical Trial Manager to lead and oversee complex clinical trials. This is a fully remote position, offering significant flexibility to manage your work from home anywhere in Kenya. You will be responsible for the overall planning, execution, and successful completion of clinical trials, ensuring adherence to protocols, timelines, budgets, and regulatory requirements. The ideal candidate possesses strong leadership skills, a deep understanding of clinical trial operations, and the ability to effectively manage cross-functional teams in a remote environment. You will be instrumental in delivering critical clinical research projects for our client's diverse portfolio.
Key Responsibilities- Develop comprehensive clinical trial management plans, including timelines, budgets, and resource allocation.
- Oversee all aspects of clinical trial execution from site selection and initiation to close-out.
- Manage and mentor clinical trial teams, including CRAs, CTAs, and data managers, fostering a collaborative and high-performing remote work environment.
- Ensure compliance with Good Clinical Practice (GCP), ICH guidelines, and all applicable regulatory requirements.
- Manage trial budgets effectively, tracking expenditures and ensuring projects remain within financial parameters.
- Oversee the quality of data collected, ensuring accuracy, completeness, and integrity through effective monitoring strategies.
- Liaise with investigators, site staff, ethics committees, and regulatory authorities.
- Manage relationships with external vendors and service providers involved in the trial.
- Prepare study-related documentation, including protocols, investigator brochures, and safety reports.
- Identify, assess, and mitigate risks associated with clinical trial conduct.
- Bachelor's degree in a scientific or healthcare-related field. A Master's degree or relevant professional certification is highly desirable.
- Minimum of 7 years of progressive experience in clinical research, with at least 3 years in a Clinical Trial Manager role.
- Proven track record of successfully managing multiple clinical trials simultaneously from start to finish.
- Extensive knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trials in various regions.
- Demonstrated experience working effectively in a remote or virtual team setting.
- Strong leadership, project management, and organizational skills.
- Excellent communication, negotiation, and interpersonal skills.
- Proficiency in clinical trial management systems (CTMS), electronic data capture (EDC) systems, and other relevant software.
- Ability to manage complex budgets and timelines.
- Problem-solving skills and the ability to make sound decisions under pressure.
Our client offers an exceptionally competitive salary package, reflecting the seniority and critical nature of this role. A comprehensive benefits package includes premium health, dental, and vision insurance, life insurance, and a robust retirement savings plan. Enjoy the ultimate flexibility of a fully remote position, allowing for an excellent work-life balance. Opportunities for continuous professional development, including leadership training and conference participation, are readily available. Generous paid time off, including annual leave, personal days, and sick leave, is provided. You will be part of a leading CRO, working on groundbreaking clinical research projects that impact global health. Access to cutting-edge technology and support systems ensures your success in this remote role.
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Clinical Trial Assistant - Pharmaceutical Operations Support
Posted 3 days ago
Job Viewed
Job Description
- Assist CRAs and investigators with the preparation, maintenance, and filing of essential trial documents (e.g., Investigator Site Files - ISF).
- Manage and track study supplies and investigational medicinal products at trial sites.
- Assist in the preparation and distribution of study-related materials.
- Schedule and coordinate investigator meetings, site initiation visits, and monitoring visits.
- Assist with data entry and management, ensuring accuracy and completeness of trial data.
- Communicate with investigative sites to gather required information or documentation.
- Ensure compliance with Good Clinical Practice (GCP) and company SOPs.
- Prepare site visit reports and follow-up on action items.
- Support the setup and maintenance of Electronic Data Capture (EDC) systems.
- Perform administrative tasks as needed to support the clinical operations team.
- High school diploma or equivalent; a Bachelor's degree in a life science, healthcare, or related field is a plus.
- Previous experience in an administrative role, preferably within a clinical research or **pharmaceutical** setting.
- Familiarity with clinical trial processes and terminology is advantageous.
- Strong organizational skills and meticulous attention to detail.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
- Excellent communication and interpersonal skills.
- Ability to multitask and prioritize workload effectively in a fast-paced environment.
- Proactive attitude and willingness to learn.
- Knowledge of GCP principles is a plus.
- Must be based in or willing to relocate to **Malindi, Kilifi, KE**.
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Job Description
**The Position**
**JOB OBJECTIVE(s):**
To maintain and continuously improve the afliate quality system in compliance with Roche Pharmaceutical Quality System requirements, local GxP-regulations and applicable ISO-standards whilst ensuring an uninterrupted supply of quality products to patients.
**Key Responsibilities**
**●** To conduct regular management review of the QMS by presenting and tracking performance against relevant standards
● To implement quality system in line with ISO/relevant standards by reviewing and understanding divisional SOP, analyse their impact in the local environment and effecting relevant aspects as required
● To identify discrepancies and investigate them via the available quality systems in a timely manner
● To identify and manage changes to processes, persons or systems, evaluate its impact and affected parties, implement planned actions and communicate as required
● To implement local CAPA management by identifying the probable root cause, proposing relevant corrective and/or preventative actions, executing the identied action and evaluating the effectiveness as required
● To conduct quality risk assessments using the quality risk assessment tools , identify risk areas, implementing risk mitigation/elimination measures,and monitor changes as required
● To ensure data integrity by creating, maintaining or implementing relevant SOPs
● To initiate or support quality audits by performing self-inspections, external audits. Identify audit queries, draft audit reports, engage with the relevant parties to implement corrective action and follow up on agreed actions
● To initiate annual mock recall and support actual recall process by informing the Health authority, liaising with the distributor(s) to facilitate product recall, contacting customers and reconciling the returned goods as required
● To maintain up to date knowledge of PQS by participating in physical trainings or provided in virtual learning platforms as required
● To perform training of personnel involved in GxP activities
● To maintain systems for reporting product complaints, including monitoring of the generic product complaints mailbox on business days
● To manage all complaints received based on the the applicable SOP
● Release commercial batches to the local market, and where applicable, Investigation Medicinal Products to the local clinical trial sites, according to the local regulations, Marketing Authorizations and Clinical Trial Authorizations
● To ensure all required KPI's in the product release process are met and feedback is provided as required
● To support the returns process by implementing the relevant SOP, ● Ensure compliance with GDP guidelines and local regulations for the products distributed to the market
● Support batch traceability for all batches received and distributed by the local warehouse
● Coordinate with the supply chain responsible to manage additional controls for cold chain management
● To support the identication and selection process for GxP suppliers ● To create and maintain quality agreement with the GxP supplier ● To assist with oversight of warehouse and distribution business partners by
monitoring compliance with the required standards stipulated in the quality agreement
● To ensure implementation of the SOPs, identify areas of concern and address these with the service providers until resolved.
● Perform audits and assessment of contracted third parties
● To liaise with internal and external stakeholders by providing input on quality standards and procedures, liaising with them on procedures and building skills in the quality standards and procedure requirements as required
**WHO ARE YOU?**
● University degree in one of the following or related science disciplines: pharmacy, medicine, pharmaceutical chemistry and technology, or biology
● 3 - 5 years' experience in pharmaceutical or medical device environment, Regulatory and Quality Assurance Management
● Demonstrate evidence of maintaining and upholding rules and SOP's
Must have knowledge of:
● Current regulatory framework and regulations
● Quality assurance and Quality Management within pharmaceutical environment
● ISO Standards
**Who we are**
A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let's build a healthier future, together.
**Roche is an Equal Opportunity Employer.**
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Job Description
Location: Eldoret, Kenya
Employment Type: Future Opportunity (Talent Pipeline)
**About the Opportunity**
We are building a pipeline of talented professionals for anticipated Junior Medical Science Liaison (MSL) roles. While these positions are not currently open, we invite expressions of interest from individuals passionate about medical affairs and scientific engagement. Joining our pipeline means you'll be among the first to hear about new opportunities as they arise.
**Key Responsibilities**
+ Serve as a scientific resource, supporting healthcare professionals and internal teams with evidence-based information.
+ Communicate clinical and scientific data in a clear, balanced, and non-promotional manner.
+ Support medical education and respond to medical inquiries in accordance with applicable laws and company policies.
+ Collaborate with cross-functional teams to ensure alignment on scientific communication and compliance with all regulatory requirements.
**Ideal Candidate Profile**
+ Advanced degree in life sciences (PharmD, PhD, MD, or equivalent).
+ Full Driving License.
+ Strong scientific acumen and ability to interpret clinical data.
+ Fluent skills in both local language and English
+ Excellent communication and presentation skills.
+ Interest in building professional relationships with healthcare professionals.
+ Willingness to travel within the region.
+ Commitment to upholding ethical standards and compliance with all relevant regulations and company policies.
**Why Join Our Talent Pipeline?**
+ Be the first to know about upcoming opportunities.
+ Gain insights into our company culture and medical affairs team.
+ Stay connected for future career development.
**How to Apply**
If you are interested in joining our talent pipeline, please submit your CV. We will keep you informed about relevant opportunities as they become available.
**\#LI-CES**
**\#LI-VK1**
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
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Job Description
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Medical Science Liaison (MSL)
Posted 2 days ago
Job Viewed
Job Description
Our client, a leading biopharmaceutical company with a strong focus on specialty therapeutics, is seeking an experienced and scientifically driven Medical Science Liaison (MSL) to cover the Ongata Rongai and surrounding regions. This hybrid role requires a deep understanding of a specific therapeutic area and the ability to engage with key opinion leaders (KOLs) and healthcare professionals (HCPs). You will serve as a vital scientific resource, disseminating complex medical information and gathering valuable insights from the medical community. The position involves a mix of remote work for planning and administrative tasks, and significant travel within the territory to meet with KOLs and HCPs.
Key Responsibilities- Establish and maintain peer-to-peer relationships with national and regional KOLs and HCPs within the assigned therapeutic area.
- Present complex scientific and clinical data on company products in a clear and accurate manner.
- Gather and relay important clinical insights, unmet medical needs, and competitive intelligence from the field to internal teams.
- Respond to unsolicited medical information requests from HCPs and support Investigator-Initiated Studies (IIS).
- Collaborate with internal Medical Affairs, Clinical Development, and Commercial teams to ensure alignment of scientific strategies.
- Identify potential investigators for clinical trials and provide scientific support.
- Participate in relevant scientific congresses, advisory boards, and medical education events.
- Develop and deliver scientific presentations and training materials.
- Ensure all activities are conducted in compliance with company policies, industry guidelines, and regulatory requirements.
- Contribute to the development of the regional medical strategy.
- Advanced scientific degree (MD, PharmD, Ph.D.) in a life science or healthcare-related field.
- Minimum of 3-5 years of experience as a Medical Science Liaison or in a similar medical affairs role.
- In-depth knowledge and expertise in a specific therapeutic area relevant to our client's portfolio.
- Proven ability to build and maintain strong relationships with KOLs and HCPs.
- Excellent presentation, communication, and interpersonal skills.
- Strong analytical and critical thinking abilities.
- Ability to work independently and manage travel effectively within a defined territory.
- Proficiency in understanding and interpreting clinical trial data.
- Familiarity with pharmaceutical industry regulations and ethical guidelines.
- Reside within or be willing to relocate to the assigned territory covering Ongata Rongai .
Our client offers a highly competitive salary, bonus structure, and a comprehensive benefits package, including premium health insurance, life insurance, and retirement savings. This hybrid role provides a balance of remote flexibility and the opportunity for impactful field engagement. Opportunities for professional growth and development, including advanced scientific training and leadership programs, are emphasized. Generous paid time off, including annual leave and sick leave, is provided. You will be part of a scientifically focused organization working on innovative treatments that address significant unmet medical needs. A company car, fuel card, and other necessary resources for field activities are provided.
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Senior Biostatistician - Global BIOS (Permanent Homebased)
Posted 18 days ago
Job Viewed
Job Description
The Global Biostatistics (Data Sciences, Safety & Medical) team at IQVIA are experienced in submissions for all major regions; working together with key groups such as, Global Regulatory Affairs, Safety, Project and Data Management, and Medical Writing, to drive efficiency and accountability.
IQVIA Biostatistics helps interpret and draw inferences from data collected on patients as they progress through a clinical trial and serves as the bridge between data capture and reporting.
We have one of the largest Biostatistics departments within the industry of around 1,100+ staff, to which we engage the full range of industry-leading resources and expertise spanning all study phases and therapeutic areas.
**Job Overview:**
As a Senior Biostatistician, you will be given access to cutting-edge, in-house technology and opportunities to work on global projects across a variety of therapeutic areas.
You will provide statistical consulting and technical support as it relates to the design, statistical analysis, and regulatory submissions of clinical trial studies.
Acting as a statistical team lead for single, complex studies or groups of studies, you will manage the scope of work and budget, providing revenue and resource forecasts, coupled with preparing proposal text and attending bid defense meetings.
You will also collaborate with medical and programming staff to produce interim reports and final reports, allowing a comprehensive understanding and interpretation of the clinical trial data and outcome.
**Requirements:**
+ BSc or MSc degree in Biostatistics or related field and between 4 - 6 years' relevant experience
+ Familiarity with moderately complex statistical methods that apply to applicable clinical trials
+ Good working knowledge of SAS and CDISC SDTM and ADaM
+ Ability to effectively manage multiple tasks and project, ability to communicate and explain statistics
**Join IQVIA to see where your skills can take you**
+ Global exposure
+ Variety of therapeutic areas
+ Collaborative and supportive team environment
+ Access to cutting-edge and innovative, in-house technology
+ Excellent career development and progression opportunities
+ Work-Life Balance, with a strong focus on a positive well-being
**Unleash your potential!**
It takes passion to make the extraordinary possible for patients. Our culture of innovation and collaboration enables us to explore new possibilities and help improve health around the world.
When you join our diverse, global team, you'll harness the power of unparalleled data, advanced analytics, cutting-edge technologies, and deep healthcare and scientific expertise to drive healthcare forward.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
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Job Description
- Lead and mentor the quality assurance team, providing guidance and setting performance standards.
- Develop, implement, and maintain robust quality management systems (QMS) and standard operating procedures (SOPs).
- Conduct regular internal audits and inspections to ensure compliance with quality standards and regulations.
- Analyze quality data, identify trends, and recommend corrective and preventive actions (CAPA).
- Collaborate with production and R&D departments to resolve quality issues and improve product consistency.
- Ensure all products meet specified quality parameters and regulatory requirements.
- Oversee the management of non-conforming products and implement appropriate disposition processes.
- Stay updated on industry best practices, regulatory changes, and new quality assurance technologies.
- Train production staff on quality standards and procedures.
- Prepare comprehensive quality reports for management review.
- Bachelor's degree in Food Science, Chemistry, Biology, or a related field.
- Minimum of 6 years of experience in quality assurance or quality control, with at least 2 years in a lead or supervisory role.
- In-depth knowledge of quality management systems (e.g., ISO 9001, HACCP, GMP).
- Strong analytical and problem-solving skills, with the ability to interpret complex data.
- Excellent leadership, communication, and interpersonal skills.
- Experience in the agricultural processing or food manufacturing industry is highly desirable.
- Proficiency in quality control software and data analysis tools.
- Ability to work effectively in both on-site and remote settings as required by the hybrid model.
- Detail-oriented and committed to maintaining the highest quality standards.
- Knowledge of **Kericho, Kericho, KE** regulatory landscape is advantageous.
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