Senior Clinical Trial Coordinator - FSP - Kenya

Join Our Team as a Senior Clinical Trial Coordinator

Be part of a global leader supporting over 750 biotechs and the top 50 pharmaceutical companies across more than 2,700 clinical trials worldwide. We invite you to contribute by providing critical administrative and technical assistance within our Project Team.

Key Responsibilities

• Manage and coordinate assigned trial functions according to role specifics (Central or Local) based on predefined task matrices.
• Conduct internal, country, and investigator file audits, documenting results thoroughly in designated systems.
• Ensure timely delivery of assigned tasks maintaining budget and quality standards while promptly reporting risks to management.
• Maintain study documentation and assist with global system support including lists, training requirements tracking, system access, and project activity monitoring.
• Provide support for electronic Trial Master File (eTMF) via review schedules and documentation of findings.
• Support Risk-Based Monitoring (RBM) efforts and perform various administrative duties like document processing, mass communications, and internal reporting.
• Organize and schedule meetings, prepare minutes, and manage local regulatory documentation and its transmission to clients and IRB/IEC.
• Analyze study metrics, reconcile findings, maintain vendor trackers, and assist with Investigator Site File and Pharmacy binder preparations along with non-clinical supply coordination.
• Support translation requests and quality control as needed and may participate in kick-off meetings to capture notes.

Qualifications & Experience

• Secondary school diploma or equivalent with relevant academic or vocational qualifications is required; Bachelor's degree is preferred.
• At least 4 years of relevant experience or an equivalent combination of education, training, and experience.

Required Skills and Competencies

• Ability to work independently or collaboratively within a team.
• Strong organizational aptitude and attention to detail to manage multiple responsibilities effectively.
• Proficient in data analysis to ensure accuracy and project efficiency.
• High customer orientation and adaptability to shifting priorities and timelines.
• Sound knowledge of country regulations, ICH Good Clinical Practices, and SOPs for clinical trial operations.
• Fluency in English with strong grammar skills; proficiency in local languages beneficial.
• Competent presentation and computer skills with proficiency in MS Office and clinical trial databases.
• Commitment to complete required clinical training programs.
• Self-motivated with a positive demeanor and strong interpersonal skills.

Working Environment and Conditions

• Work primarily in an office environment with occasional visits to clinical or laboratory sites.
• Exposure to office electrical equipment and potential occasional travel to site locations.
• Standard working days from Monday to Friday.