2,092 Clinical Research Associate Pharmaceutical Development jobs in Kenya
Clinical Research Associate - Pharmaceutical Development
Posted 8 days ago
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Key Responsibilities:
- Initiate, monitor, and close-out clinical investigator sites.
- Ensure clinical trials are conducted, recorded, and reported in accordance with protocol, standard operating procedures (SOPs), and applicable regulations.
- Verify the accuracy and completeness of clinical trial data through source data verification.
- Ensure patient safety and rights are protected.
- Manage and resolve data queries in collaboration with investigators and study staff.
- Train and provide ongoing support to site staff.
- Oversee regulatory compliance at study sites.
- Prepare and present monitoring visit reports.
- Liaise effectively between the sponsor, investigators, and other stakeholders.
- Ensure timely submission of study-related documents.
- Proven experience as a Clinical Research Associate (CRA) or similar role in clinical research.
- In-depth knowledge of GCP guidelines, ICH regulations, and local regulatory requirements.
- Experience in site monitoring, data verification, and query resolution.
- Strong understanding of clinical trial processes and documentation.
- Excellent organizational and time management skills.
- Exceptional attention to detail and accuracy.
- Strong written and verbal communication skills.
- Ability to work independently and travel as needed (though the role is primarily remote).
- Bachelor's degree in a life science, nursing, or related field.
Senior Clinical Research Associate - Pharmaceutical Development
Posted 21 days ago
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Key Responsibilities:
- Conduct remote site initiation, monitoring, and close-out visits according to protocol and GCP.
- Verify the accuracy, completeness, and consistency of clinical data through source data verification (SDV).
- Ensure compliance with all applicable regulatory requirements (e.g., FDA, EMA) and study protocols.
- Manage investigational product accountability and ensure proper storage and handling at trial sites.
- Serve as the primary point of contact for assigned clinical trial sites, addressing site staff queries and issues.
- Identify, track, and resolve data discrepancies and protocol deviations.
- Ensure timely reporting of adverse events (AEs) and serious adverse events (SAEs).
- Provide training and ongoing support to site personnel.
- Prepare and present site monitoring reports.
- Collaborate with internal teams, including clinical operations, data management, and regulatory affairs.
- Bachelor's degree in a life science, nursing, pharmacy, or a related discipline. Advanced degree preferred.
- Minimum of 5 years of progressive experience as a Clinical Research Associate.
- In-depth knowledge of ICH-GCP guidelines and regulatory requirements for clinical trials.
- Proven experience in monitoring clinical trials across various therapeutic areas.
- Strong understanding of clinical trial processes, from study start-up to close-out.
- Excellent analytical, problem-solving, and organizational skills.
- Exceptional communication, interpersonal, and negotiation skills, particularly in managing remote relationships.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to work independently, manage time effectively, and travel as needed (though the role is primarily remote).
- Relevant certifications (e.g., ACRP, SoCRA) are a plus.
Remote Clinical Research Associate - Pharmaceutical Development
Posted 8 days ago
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Remote Senior Data Scientist - Clinical Research
Posted 21 days ago
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Remote Pharmaceutical Formulation Scientist - Drug Development
Posted 17 days ago
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Job Description
Responsibilities:
- Design and develop stable, effective, and manufacturable pharmaceutical formulations for various routes of administration.
- Investigate and characterize drug substances and excipients to understand their impact on formulation performance.
- Conduct formulation development studies, including pre-formulation, formulation screening, optimization, and stability testing.
- Utilize various drug delivery technologies and approaches to enhance bioavailability, targeted delivery, or patient compliance.
- Perform analytical testing to characterize formulations, such as dissolution, particle size analysis, and viscosity.
- Scale-up formulation processes from laboratory bench to pilot scale.
- Prepare comprehensive technical reports, research summaries, and regulatory submission documents.
- Collaborate with analytical development, process development, and regulatory affairs teams.
- Stay current with scientific literature, emerging technologies, and regulatory guidelines in pharmaceutics and drug delivery.
- Troubleshoot formulation-related challenges and provide scientific insights.
- Ph.D. or Master's degree in Pharmaceutical Sciences, Pharmaceutics, Chemical Engineering, Chemistry, or a related discipline.
- Minimum of 5 years of experience in pharmaceutical formulation development within the industry.
- Proven track record of successful formulation development for small molecules and/or biologics.
- Hands-on experience with various dosage forms (e.g., oral solids, injectables, topical).
- Proficiency in analytical techniques relevant to formulation characterization.
- Strong understanding of physical chemistry, materials science, and biopharmaceutics.
- Familiarity with Good Manufacturing Practices (GMP) and regulatory submission requirements (e.g., FDA, EMA).
- Excellent problem-solving, critical thinking, and data analysis skills.
- Strong written and verbal communication skills, with the ability to present complex scientific information clearly.
- Demonstrated ability to work independently and manage research projects effectively in a remote setting.
Remote Lead Pharmaceutical Development Scientist & Regulatory Affairs Specialist
Posted 8 days ago
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Job Description
Key Responsibilities:
- Lead the scientific strategy for pharmaceutical product development, including formulation design, process development, and analytical methods.
- Oversee pre-clinical and clinical development activities, ensuring adherence to study protocols and timelines.
- Prepare and review comprehensive regulatory submission documents (e.g., IND, NDA, ANDA) for various health authorities (e.g., FDA, EMA).
- Interpret and apply global regulatory guidelines and requirements to development programs.
- Collaborate with internal teams (R&D, clinical operations, manufacturing) and external partners to advance development projects.
- Manage outsourced activities with contract research organizations (CROs) and contract manufacturing organizations (CMOs).
- Conduct risk assessments and develop mitigation strategies for development and regulatory challenges.
- Stay current with scientific advancements, emerging technologies, and evolving regulatory trends in the pharmaceutical industry.
- Provide expert guidance on regulatory strategy and compliance to project teams and senior management.
- Mentor junior scientists and regulatory affairs professionals.
Qualifications:
- Ph.D. or Master's degree in Pharmaceutical Sciences, Chemistry, Biology, or a related discipline.
- Minimum of 8 years of experience in pharmaceutical research and development, with a strong emphasis on drug development and regulatory affairs.
- Demonstrated success in leading the development of pharmaceutical products through regulatory approval.
- In-depth knowledge of drug discovery, formulation, analytical chemistry, and manufacturing processes.
- Comprehensive understanding of global regulatory requirements (e.g., ICH guidelines, FDA, EMA regulations).
- Proven experience in preparing and submitting regulatory dossiers.
- Excellent scientific judgment, analytical, and problem-solving skills.
- Strong leadership, project management, and communication skills, with experience in managing remote teams.
- Ability to work independently and manage multiple complex projects simultaneously.
- Proficiency in relevant scientific and regulatory databases and software.
Senior Pharmaceutical Formulation Scientist - Drug Development
Posted 8 days ago
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Sports Analytics Specialist
Posted 23 days ago
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Key Responsibilities:
- Collect, clean, and process large datasets related to sports performance and engagement.
- Apply statistical modeling and machine learning techniques to analyze sporting data.
- Develop predictive models to forecast player performance, game outcomes, and fan behavior.
- Create compelling data visualizations and dashboards to communicate insights.
- Collaborate with coaches, management, and marketing teams to inform strategic decisions.
- Identify trends and patterns in data to provide actionable recommendations.
- Stay current with the latest advancements in sports analytics and data science.
- Contribute to the development of data-driven strategies for athlete development and team performance.
- Present findings and insights to various stakeholders, both technical and non-technical.
- Bachelor's or Master's degree in Statistics, Data Science, Computer Science, Sports Management, or a related quantitative field.
- Proven experience in sports analytics or a similar analytical role.
- Proficiency in programming languages like Python or R for data analysis.
- Strong understanding of statistical methods, machine learning algorithms, and data mining techniques.
- Experience with database querying languages (e.g., SQL).
- Excellent data visualization skills using tools like Tableau, Power BI, or similar.
- Strong analytical and problem-solving abilities.
- Excellent communication and presentation skills, with the ability to explain complex findings clearly.
- A deep passion for sports and an understanding of various sports disciplines.
Remote Financial Analyst Specialist
Posted 23 days ago
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Remote Sports Analytics Specialist
Posted 21 days ago
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