We currently have an opportunity for a CRA to join our Clinical Monitoring department in Kenya as a CRA. This opportunity can be home-based from  Nairobi or Kisumu.

Our global Clinical Monitoring department consists of colleagues with institutional knowledge, in-depth therapeutic experience. Together, we help clients define and develop clinical programmes, minimise delays and execute high-quality, cost-efficient clinical studies.

• You would be working in multi-national projects working closely with our sponsors and be focused on delivering exemplary levels of customer service on multiple, challenging projects.
• Performing and coordinating all aspects of the clinical monitoring process independently, monitoring visits and your will be managing your own studies. 
• You will be given training programmes that will assist your technical and professional skills and knowledge. This would happen in case you have not worked in certain therapeutic areas before and you would like to expand your knowledge then there is certainly this option as well. 

Job Qualification

• University degree in a life-sciences field 
• Minimum 2+ year of Independent, on-site monitoring experience in a Pharmaceutical or Clinical Research Organisation    
• Demonstrated understanding of ICH-GCP, EU and FDA requirements 
• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology 
• Exceptional communication, collaboration, organisational and time management skills 
• Fluency in English language is essential 

Our Biostatistics & Programming (B&P) department are passionate about being data and technically agile and driving enhanced value for our clients and patients. Determined to improve patient health, we help the business provide industry leading CDISC expertise and programming leadership through global delivery, consistent quality adherence and scientific insight.

Your responsibilities will include (but are not limited to) the following:

• Creation of specifications, development, validation, and delivery of CDISC SDTM and regulatory deliverables (eCRT Define.xml, SDTM aCRF).
• Analysing and combining data from a variety of sources and structures including virtual trials, wearables, eCOA, etc.
• Generating visualizations (Spotfire), Statistical safety reports (TLFs), safety event notifications and data alerts for study teams.
• Provide consult, analysis, and support across various therapeutic area studies in their CDISC compliance and consistency in mapping.
• Act as programming lead on Phase II-IV studies of moderate to high complexity.
• As programming lead working directly with project team leaders and client representatives and where required to conduct team meetings, develop, and maintain project timelines, assess, and forecast resources, and monitor study budgets.
• Develop instructional training and education materials for the wider B&P community.
• Provide mentorship to junior team members.

Job Qualification

Education, Experience and Skills required:

• MS/MA degree in computer science, statistics, biostatistics, mathematics or related field and 4-5+ years of experience.
• In-depth understanding of SAS and, ideally, one other programming language.
• In-depth understanding of relational data base structure and complex data systems.
• Capable of effectively capturing biostatistical metrics.
• Capable of providing quality control review for statistical programming and identifying solutions and process improvements.
• Capable of independently and effectively organizing and managing multiple assignments with challenging timelines.
• Solid project management skills to act as project lead across the most challenging and complex projects.
• Demonstrated leadership, initiative, and motivation.
• Capable of training and mentoring others.
• Fluent in English.