9 Clinical Development jobs in Kenya
Clinical Research Associate - Pharmaceutical Development
60100 Embu, Eastern
KES130000 Annually
WhatJobs
Posted today
Job Viewed
Job Description
Our client, a leading pharmaceutical innovator, is seeking a dedicated and meticulous Clinical Research Associate (CRA) to join their esteemed team. This is a fully remote role, offering a unique opportunity to contribute to groundbreaking medical advancements from the comfort of your home. As a CRA, you will play a vital role in ensuring the quality and integrity of clinical trials, overseeing all aspects of site management and data collection. Your responsibilities will include conducting pre-study visits, site initiation visits, routine monitoring visits, and close-out visits at clinical trial sites. You will be responsible for verifying that the trial is conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), and applicable regulatory requirements (e.g., ICH-GCP, FDA, EMA). This involves thorough review of source documents, patient records, and case report forms (CRFs) to ensure data accuracy and completeness. You will also be responsible for managing communication with investigators and site staff, providing training on trial procedures, and addressing any queries or concerns. The ideal candidate will possess excellent organizational skills, a keen eye for detail, and a strong understanding of clinical trial processes and regulatory guidelines. Your ability to build rapport and maintain professional relationships with site personnel is crucial. This role requires a proactive approach to problem-solving and a commitment to upholding the highest ethical standards in clinical research. We seek individuals who are passionate about patient safety and contributing to the development of new therapies. The ability to manage your time effectively and work independently within a remote setting is essential for success.
Responsibilities:
Responsibilities:
- Monitor clinical trial sites to ensure compliance with protocols, SOPs, and regulatory requirements.
- Verify the accuracy, completeness, and integrity of clinical trial data through source document verification.
- Manage communication with investigators and study site staff, providing guidance and support.
- Conduct site visits, including pre-study, initiation, monitoring, and close-out visits.
- Ensure proper documentation is maintained at study sites.
- Identify and report adverse events and protocol deviations.
- Train site personnel on trial-related procedures and regulatory requirements.
- Assist in the resolution of data queries and discrepancies.
- Ensure timely submission of essential documents and study supplies.
- Contribute to the development of clinical trial documentation.
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
- Minimum of 3 years of experience as a Clinical Research Associate or in a similar role.
- In-depth knowledge of ICH-GCP guidelines and regulatory requirements.
- Experience with various clinical trial phases and therapeutic areas.
- Proficiency in electronic data capture (EDC) systems and clinical trial management systems (CTMS).
- Excellent attention to detail and organizational skills.
- Strong analytical and problem-solving abilities.
- Effective communication and interpersonal skills.
- Ability to work independently and manage multiple priorities in a remote environment.
- Certification from a recognized clinical research professional body is a plus.
This advertiser has chosen not to accept applicants from your region.
0
Clinical Research Associate - Pharmaceutical Development
00207 Gathiruini
KES380000 Annually
WhatJobs
Posted 7 days ago
Job Viewed
Job Description
Our client, a prominent pharmaceutical company dedicated to advancing healthcare, is actively recruiting for a diligent and detail-oriented Clinical Research Associate (CRA) to join their expanding clinical development team. This pivotal role involves overseeing and managing clinical trials from initiation through to closure, ensuring adherence to strict regulatory guidelines, protocols, and Good Clinical Practice (GCP) standards. The CRA will be instrumental in monitoring trial progress, ensuring data integrity, and safeguarding the rights and well-being of study participants. This position requires a strong scientific background, meticulous organizational skills, and a commitment to ethical research practices.
Key Responsibilities:
Key Responsibilities:
- Identify, evaluate, and qualify clinical investigator sites.
- Initiate, monitor, and close-out clinical trial sites in accordance with study protocols and regulatory requirements.
- Ensure accurate, complete, and timely collection of clinical data, including source document verification and data review.
- Conduct pre-study visits, initiation visits, routine monitoring visits, and close-out visits at investigator sites.
- Train and manage site staff on study protocols, procedures, and regulatory requirements.
- Monitor study drug accountability and storage at investigator sites.
- Prepare and maintain essential study documents, ensuring compliance with regulatory standards.
- Act as the primary liaison between the sponsor and the investigator sites.
- Identify and report adverse events and serious adverse events promptly.
- Participate in protocol and study-related training and meetings.
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related scientific discipline.
- Minimum of 3 years of experience as a Clinical Research Associate or in a similar clinical trial management role.
- In-depth knowledge of ICH-GCP guidelines and other relevant regulatory requirements.
- Demonstrated experience in monitoring clinical trials across various therapeutic areas.
- Excellent understanding of clinical trial processes and documentation.
- Strong communication, interpersonal, and organizational skills.
- Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to travel to sites within **Mlolongo, Machakos** and surrounding areas as required.
- High level of attention to detail and accuracy.
- Ability to work independently and as part of a collaborative team.
This advertiser has chosen not to accept applicants from your region.
1
Lead Biostatistician - Clinical Trials
80100 Nairobi, Nairobi
KES400000 Annually
WhatJobs
Posted today
Job Viewed
Job Description
Our client, a leading organization in scientific research and development, is seeking an experienced Lead Biostatistician to oversee statistical analysis for critical clinical trials. This hybrid role offers a dynamic blend of remote work flexibility and essential on-site collaboration in **Malindi, Kilifi, KE**. You will be responsible for designing statistical analysis plans, developing study protocols, and ensuring the integrity and accuracy of statistical methodologies applied throughout clinical research. Your expertise will be crucial in analyzing complex biological and clinical data, interpreting results, and contributing to research publications and regulatory submissions. You will lead a team of biostatisticians, providing mentorship, guidance, and technical oversight. Key responsibilities include collaborating with researchers, clinicians, and data managers to define study endpoints, sample sizes, and data collection strategies. The ideal candidate will possess a strong theoretical and practical understanding of statistical methods commonly used in clinical trials, including survival analysis, longitudinal data analysis, and mixed-effects models. Proficiency in statistical software packages such as SAS, R, or Stata is mandatory. You must have exceptional analytical skills, a keen eye for detail, and the ability to communicate complex statistical concepts effectively to both technical and non-technical audiences. Experience in leading statistical teams and managing multiple research projects simultaneously is highly desirable. Join our innovative team and contribute to groundbreaking scientific advancements.
Responsibilities:
Responsibilities:
- Lead the design and execution of statistical analysis for clinical trials.
- Develop statistical analysis plans (SAPs) and study protocols.
- Analyze complex biological and clinical data using advanced statistical methods.
- Interpret statistical results and contribute to research findings and publications.
- Provide statistical expertise and guidance to research teams.
- Supervise and mentor a team of biostatisticians.
- Ensure adherence to Good Clinical Practice (GCP) and regulatory guidelines.
- Collaborate with clinicians, data managers, and regulatory affairs professionals.
- Contribute to the development of innovative statistical methodologies.
- Master's or Ph.D. in Biostatistics, Statistics, or a related quantitative field.
- Minimum of 8 years of experience in biostatistics, with a significant focus on clinical trials.
- Proven experience in leading statistical analysis teams and projects.
- Expertise in statistical software such as SAS, R, or Stata.
- Strong knowledge of clinical trial design and statistical methodologies.
- Excellent analytical, problem-solving, and critical thinking skills.
- Exceptional communication and interpersonal skills.
- Ability to work effectively in a hybrid work environment, balancing remote and on-site contributions in **Malindi**.
This advertiser has chosen not to accept applicants from your region.
2
Remote Senior Biostatistician - Clinical Trials
00204 Gathiruini
KES190000 Annually
WhatJobs
Posted today
Job Viewed
Job Description
Our client, a leader in pharmaceutical research, is seeking a highly experienced Remote Senior Biostatistician to support their clinical trial operations. This is a fully remote position, allowing you to contribute from your home office. You will be responsible for the statistical design, analysis, and reporting of clinical trial data, ensuring the integrity and validity of research findings. The ideal candidate possesses a strong statistical background, extensive experience in clinical trial methodology, and a commitment to advancing medical science through rigorous data analysis.
Key Responsibilities:
Qualifications:
Key Responsibilities:
- Design statistical analysis plans (SAPs) for clinical trials, ensuring adherence to regulatory guidelines.
- Perform statistical analyses of clinical trial data using SAS or R, including descriptive statistics, inferential statistics, and advanced modeling techniques.
- Interpret statistical results and collaborate with clinical teams to draw meaningful conclusions.
- Prepare statistical reports, tables, figures, and listings for regulatory submissions and publications.
- Contribute to the development of study protocols, case report forms (CRFs), and data management plans.
- Ensure the quality and accuracy of statistical analyses and documentation.
- Stay current with regulatory requirements (e.g., FDA, EMA) and industry best practices in biostatistics.
- Mentor and guide junior biostatisticians and statistical programmers.
- Collaborate with data management, clinical operations, and medical writing teams.
- Participate in the review of study designs and statistical methodologies.
- Contribute to the scientific advancement of clinical research through robust statistical analysis.
Qualifications:
- Master's or Ph.D. in Biostatistics, Statistics, or a related quantitative field.
- Minimum of 5-7 years of experience in biostatistics, specifically in clinical trial analysis.
- Expertise in statistical software such as SAS or R is mandatory.
- Strong understanding of clinical trial design, methodologies, and regulatory requirements.
- Proven ability to develop and execute statistical analysis plans.
- Excellent analytical, problem-solving, and critical thinking skills.
- Strong written and verbal communication skills, with the ability to present complex statistical information clearly.
- Demonstrated experience working effectively in a remote, collaborative team environment.
- Familiarity with CDISC standards and data submission requirements.
This advertiser has chosen not to accept applicants from your region.
3
Remote Lead Biostatistician - Clinical Trials
80201 Nairobi, Nairobi
KES700000 Annually
WhatJobs
Posted 3 days ago
Job Viewed
Job Description
Our client is seeking an accomplished and detail-oriented Lead Biostatistician to join our globally distributed, fully remote clinical operations team. In this critical role, you will be responsible for providing statistical expertise and leadership for the design, execution, and analysis of clinical trials across various therapeutic areas. You will lead the development of statistical analysis plans, ensure the integrity and accuracy of clinical trial data, and oversee the statistical reporting of study results for regulatory submissions and publications. The ideal candidate possesses extensive experience in biostatistics within the pharmaceutical or biotechnology industry, with a strong understanding of clinical trial methodologies and regulatory requirements. You will work closely with clinical teams, data management, and programming to ensure robust statistical methodologies are applied throughout the trial lifecycle. This position requires exceptional analytical skills, proficiency in statistical software (e.g., SAS, R), and the ability to translate complex statistical concepts into clear, actionable insights. As a remote-first organization, we emphasize proactive communication, effective collaboration through digital tools, and a commitment to scientific excellence. You will be a key contributor to our mission of bringing innovative therapies to patients worldwide, leveraging your statistical acumen from the comfort of your home office. Your leadership will guide statistical programming teams and ensure adherence to statistical best practices and quality standards. We expect a proactive approach to problem-solving and a dedication to continuous learning in the ever-evolving field of clinical research. Join our team and make a tangible impact on global health outcomes through rigorous statistical analysis and strategic input.
Responsibilities:
Qualifications:
Responsibilities:
- Lead the statistical design and analysis of clinical trials.
- Develop and finalize Statistical Analysis Plans (SAPs).
- Oversee the programming and validation of statistical outputs.
- Interpret statistical results and contribute to clinical study reports.
- Provide statistical support for regulatory submissions (e.g., IND, NDA).
- Mentor and guide junior biostatisticians and statistical programmers.
- Ensure compliance with statistical methodologies and industry standards.
- Collaborate with cross-functional teams on study design and analysis strategy.
- Review and approve data management plans from a statistical perspective.
Qualifications:
- Master's or Ph.D. in Statistics, Biostatistics, or a related quantitative field.
- Minimum of 7 years of experience in biostatistics within the pharmaceutical/biotech industry.
- Demonstrated experience in designing and analyzing Phase I-IV clinical trials.
- Expertise in statistical programming languages such as SAS and/or R.
- Strong knowledge of statistical methodologies and regulatory guidelines.
- Excellent communication, presentation, and interpersonal skills.
- Proven leadership capabilities.
- Ability to work effectively in a remote, collaborative environment.
This advertiser has chosen not to accept applicants from your region.
4
Remote Pharmaceutical Data Analyst - Clinical Trials
40100 Kisumu
KES90000 Annually
WhatJobs
Posted 4 days ago
Job Viewed
Job Description
Our client is seeking a meticulous and experienced Remote Pharmaceutical Data Analyst to support critical clinical trial operations. This position requires a deep understanding of pharmaceutical data management and analysis to ensure the integrity and accuracy of trial results.
Key Responsibilities:
Qualifications:
This fully remote role offers a significant opportunity to contribute to the development of life-saving medicines.
Key Responsibilities:
- Collect, clean, validate, and manage clinical trial data from various sources, ensuring compliance with regulatory standards (e.g., GCP, CDISC).
- Perform statistical analysis of clinical trial data to identify trends, patterns, and significant findings.
- Develop and maintain databases and data management systems for clinical trials.
- Generate reports, tables, listings, and figures for clinical study reports (CSRs), regulatory submissions, and internal reviews.
- Collaborate with clinical research associates (CRAs), statisticians, and medical writers via remote communication channels to address data queries and ensure data quality.
- Develop and execute data validation plans and identify discrepancies.
- Assist in the design of clinical trial databases and electronic data capture (EDC) systems.
- Stay updated on data management best practices, regulatory requirements, and industry standards in pharmaceutical research.
- Contribute to the development of data management plans (DMPs) and standard operating procedures (SOPs).
- Ensure data security and confidentiality at all times.
Qualifications:
- Bachelor's degree in Statistics, Biostatistics, Computer Science, Bioinformatics, Pharmacy, or a related quantitative field.
- Minimum of 3 years of experience in data management or data analysis within the pharmaceutical or biotechnology industry, specifically in clinical trials.
- Proficiency in statistical software packages such as SAS, R, or SPSS.
- Experience with Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Oracle Clinical) is highly desirable.
- Strong understanding of Good Clinical Practice (GCP) guidelines and CDISC standards.
- Excellent analytical, problem-solving, and critical thinking skills.
- Meticulous attention to detail and commitment to data accuracy and integrity.
- Strong communication and collaboration skills for effective remote teamwork.
- Ability to manage multiple projects and meet strict deadlines in a remote work environment.
- Knowledge of database management principles.
This fully remote role offers a significant opportunity to contribute to the development of life-saving medicines.
This advertiser has chosen not to accept applicants from your region.
5
Clinical Research Associate - Pharmaceutical Trials
00500 Kitale, Rift Valley
KES160000 Annually
WhatJobs
Posted 2 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical company, is seeking a highly competent and meticulous Clinical Research Associate (CRA) to support the execution of clinical trials. In this role, you will be responsible for monitoring trial sites, ensuring adherence to protocols, and verifying the accuracy and completeness of data. You will play a critical part in ensuring the integrity of clinical research and compliance with Good Clinical Practice (GCP) guidelines and regulatory requirements. The ideal candidate will have a strong background in clinical research methodologies and excellent attention to detail.
Responsibilities:
Qualifications:
Responsibilities:
- Monitor assigned clinical trial sites to ensure adherence to study protocols, regulatory requirements, and company policies.
- Verify the accuracy, completeness, and consistency of clinical data through source data verification (SDV).
- Ensure proper implementation of the protocol and inform investigators of any changes.
- Conduct site initiation visits, interim monitoring visits, and close-out visits.
- Train and support site staff on study-specific procedures and documentation.
- Oversee the management of investigational product and clinical supplies at the sites.
- Report adverse events and protocol deviations promptly according to regulatory requirements.
- Build and maintain strong working relationships with investigators, site staff, and internal study teams.
- Prepare monitoring visit reports and follow up on action items identified during visits.
- Ensure all trial-related documentation is maintained accurately and filed appropriately.
- Identify potential risks and issues at the site level and implement corrective and preventive actions (CAPA).
- Participate in investigator meetings and provide input on site selection and feasibility.
- Stay current with clinical research best practices, ICH-GCP guidelines, and relevant regulations.
Qualifications:
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
- Minimum of 3-5 years of experience as a Clinical Research Associate or in a similar clinical trial management role.
- In-depth knowledge of clinical trial processes, ICH-GCP guidelines, and regulatory requirements.
- Experience with various therapeutic areas is advantageous.
- Proficiency in clinical data management systems and electronic data capture (EDC) systems.
- Strong analytical and problem-solving skills, with excellent attention to detail.
- Excellent written and verbal communication skills.
- Ability to manage multiple tasks and prioritize effectively.
- Willingness to travel frequently to clinical trial sites.
This advertiser has chosen not to accept applicants from your region.
Be The First To Know
About the latest Clinical development Jobs in Kenya !
6
Clinical Research Associate - Pharmaceutical Trials
20204 Kapsuser
KES700000 Annually
WhatJobs
Posted 4 days ago
Job Viewed
Job Description
Our client, a global pharmaceutical leader, is actively seeking a highly qualified and dedicated Clinical Research Associate (CRA) to join their expanding research team. This crucial, fully remote role will involve overseeing and managing clinical trials from initiation to close-out, ensuring compliance with regulatory standards (GCP, FDA, EMA) and protocols. You will play a vital role in bringing innovative therapies to patients by meticulously monitoring trial sites, ensuring data integrity, and supporting investigators.
Key Responsibilities:
The ideal candidate will hold a Bachelor's degree in a life science or related field, with a minimum of 3-5 years of experience as a CRA in the pharmaceutical industry. A comprehensive understanding of clinical trial phases, GCP, and relevant regulatory requirements is mandatory. Excellent organizational, analytical, and communication skills are essential, as is the ability to work independently and manage multiple priorities in a remote setting. Proficiency with clinical trial management systems (CTMS) and electronic data capture (EDC) systems is required. This is an exceptional opportunity to contribute to life-saving research within a globally recognized organization, offering a flexible, remote working environment. If you are driven by scientific advancement and possess a keen eye for detail, we invite you to apply.
Key Responsibilities:
- Identify, evaluate, and qualify clinical trial sites and investigators.
- Initiate, monitor, and close-out clinical trial sites according to study protocols and GCP guidelines.
- Conduct site visits (remote and on-site as required, though role is primarily remote focused on oversight) to assess protocol adherence, data accuracy, and patient safety.
- Ensure accurate and timely entry of data into clinical trial databases (e.g., EDC systems).
- Train site personnel on study-specific procedures, protocols, and regulatory requirements.
- Manage communication between clinical trial sites, the study team, and regulatory authorities.
- Review and ensure the completeness and accuracy of essential documents (e.g., Trial Master File).
- Oversee drug accountability and investigational product handling at sites.
- Identify and report adverse events and protocol deviations promptly.
- Prepare site monitoring reports and follow up on action items.
The ideal candidate will hold a Bachelor's degree in a life science or related field, with a minimum of 3-5 years of experience as a CRA in the pharmaceutical industry. A comprehensive understanding of clinical trial phases, GCP, and relevant regulatory requirements is mandatory. Excellent organizational, analytical, and communication skills are essential, as is the ability to work independently and manage multiple priorities in a remote setting. Proficiency with clinical trial management systems (CTMS) and electronic data capture (EDC) systems is required. This is an exceptional opportunity to contribute to life-saving research within a globally recognized organization, offering a flexible, remote working environment. If you are driven by scientific advancement and possess a keen eye for detail, we invite you to apply.
This advertiser has chosen not to accept applicants from your region.
7
Remote Clinical Research Associate - Pharmaceutical Trials
30300 Moiben
KES160000 Annually
WhatJobs
Posted 4 days ago
Job Viewed
Job Description
Our client is seeking a dedicated and meticulous Clinical Research Associate to join their esteemed pharmaceutical development team. This is a fully remote position, allowing you to play a vital role in overseeing clinical trials from anywhere. You will be responsible for ensuring the quality, integrity, and timely completion of clinical trial activities in accordance with protocol, regulatory requirements, and Good Clinical Practice (GCP) guidelines.
Key Responsibilities include:
The ideal candidate will possess a Bachelor's degree in a life science, nursing, or related field. A minimum of 3 years of experience as a Clinical Research Associate or in a similar role within the pharmaceutical or biotech industry is required. Strong knowledge of GCP, ICH guidelines, and clinical trial processes is essential. Excellent organizational, communication, and interpersonal skills are crucial for effective site management. The ability to travel occasionally to sites as needed for specific tasks may be required, but the primary role is remote. Proficiency in Electronic Data Capture (EDC) systems and clinical trial management software is highly desirable. You must be highly motivated, detail-oriented, and capable of working independently with a high degree of accuracy. This is an excellent opportunity to contribute to the advancement of pharmaceutical treatments and patient care in a remote capacity.
Key Responsibilities include:
- Monitoring clinical trial sites to ensure adherence to protocols and regulations.
- Verifying the accuracy and completeness of clinical data.
- Managing trial documentation and essential regulatory documents.
- Communicating with investigators, site staff, and internal project teams.
- Identifying and resolving site issues and deviations.
- Ensuring patient safety and rights are protected throughout the trial.
- Facilitating site initiation visits, interim monitoring visits, and close-out visits.
- Training site personnel on study procedures and data collection.
- Preparing monitoring reports and contributing to study progress updates.
- Ensuring compliance with all applicable regulatory requirements (e.g., FDA, EMA).
The ideal candidate will possess a Bachelor's degree in a life science, nursing, or related field. A minimum of 3 years of experience as a Clinical Research Associate or in a similar role within the pharmaceutical or biotech industry is required. Strong knowledge of GCP, ICH guidelines, and clinical trial processes is essential. Excellent organizational, communication, and interpersonal skills are crucial for effective site management. The ability to travel occasionally to sites as needed for specific tasks may be required, but the primary role is remote. Proficiency in Electronic Data Capture (EDC) systems and clinical trial management software is highly desirable. You must be highly motivated, detail-oriented, and capable of working independently with a high degree of accuracy. This is an excellent opportunity to contribute to the advancement of pharmaceutical treatments and patient care in a remote capacity.
This advertiser has chosen not to accept applicants from your region.
8