2,092 Senior Clinical Research Associate Pharmaceutical Development jobs in Kenya
Clinical Research Associate - Pharmaceutical Development
Posted 19 days ago
Job Viewed
Job Description
Responsibilities:
- Conduct site visits (remote and/or on-site as required, with travel as needed) to assess protocol and regulatory compliance, data accuracy, and overall site performance.
- Ensure that investigational sites adhere strictly to the study protocol, GCP, and all applicable regulatory requirements.
- Manage communication with clinical investigators and site staff, providing necessary training and ongoing support.
- Review and verify source documents, case report forms (CRFs), and other study-related records for accuracy and completeness.
- Identify, document, and resolve deviations and adverse events promptly and appropriately.
- Assist in the preparation and distribution of study-related documents and essential regulatory documents.
- Track study progress, identify potential risks, and implement mitigation strategies to ensure timely completion of study milestones.
- Participate in investigator meetings and training sessions as required.
- Contribute to the development and refinement of study protocols and clinical research processes.
Qualifications:
- A Bachelor's degree in a life science, nursing, pharmacy, or a related healthcare field. Advanced degree preferred.
- Minimum of 3-5 years of direct experience as a CRA in the pharmaceutical or biotechnology industry.
- Thorough knowledge of GCP, ICH guidelines, FDA regulations, and other relevant regulatory standards.
- Experience in monitoring various phases of clinical trials.
- Excellent organizational skills, with the ability to manage multiple priorities and deadlines effectively.
- Strong written and verbal communication skills, with the ability to document findings clearly and concisely.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to work independently and collaboratively in a remote team environment.
- This role supports global initiatives but is specifically aligned with operational oversight relevant to the Eldoret, Uasin Gishu, KE geographical area, requiring adherence to local regulatory nuances.
Senior Clinical Research Associate - Pharmaceutical Development
Posted 21 days ago
Job Viewed
Job Description
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
Job Viewed
Job Description
Remote Senior Data Scientist - Clinical Research
Posted 21 days ago
Job Viewed
Job Description
Remote Pharmaceutical Formulation Scientist - Drug Development
Posted 17 days ago
Job Viewed
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
Job Viewed
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
Job Viewed
Job Description
Be The First To Know
About the latest Senior clinical research associate pharmaceutical development Jobs in Kenya !
Sports Analytics Specialist
Posted 23 days ago
Job Viewed
Job Description
Responsibilities:
- Collect, clean, and process large sports-related datasets.
- Develop and apply statistical models to analyze player and team performance.
- Create predictive models for game outcomes, player development, and strategic planning.
- Visualize data and present findings through reports, dashboards, and presentations.
- Collaborate with coaches, athletes, and management to provide data-driven insights.
- Identify trends and patterns in sports data to inform decision-making.
- Stay updated on the latest advancements in sports analytics techniques and technologies.
- Ensure data integrity and accuracy throughout the analysis process.
- Contribute to the development of new analytical tools and methodologies.
- Communicate complex analytical concepts to diverse audiences.
- Bachelor's degree in Statistics, Mathematics, Computer Science, Data Science, or a related quantitative field. A Master's degree is preferred.
- Minimum of 3 years of experience in data analysis, statistical modeling, or a similar role, preferably within the sports industry.
- Proficiency in programming languages such as Python or R.
- Strong knowledge of SQL and database management.
- Experience with data visualization tools (e.g., Tableau, Power BI).
- Solid understanding of statistical concepts and machine learning techniques.
- Deep knowledge and passion for one or more sports.
- Excellent analytical, problem-solving, and critical thinking skills.
- Strong communication and presentation abilities.
- Ability to work independently and manage projects in a remote environment.
Remote Financial Analyst Specialist
Posted 23 days ago
Job Viewed
Job Description
Remote Sports Analytics Specialist
Posted 23 days ago
Job Viewed