Clinical Trial manager

The Clinical Trial Manager (CTM) is responsible for the end to end operational management of clinical trials conducted by Afro REACH CRO. Based in Abuja, Nigeria, the CTM will oversee the planning, execution, monitoring, and close out of clinical studies, ensuring they are delivered on time, within budget, and in full compliance with ICH GCP, regulatory requirements, and sponsor expectations.

This role serves as the primary operational liaison between sponsors, investigators, study sites, vendors, and internal project teams.

The Clinical Trial Manager (CTM) is responsible for the end to end operational management of clinical trials conducted by Afro REACH CRO. Based in Abuja, Nigeria, the CTM will oversee the planning, execution, monitoring, and close out of clinical studies, ensuring they are delivered on time, within budget, and in full compliance with ICH GCP, regulatory requirements, and sponsor expectations.

This role serves as the primary operational liaison between sponsors, investigators, study sites, vendors, and internal project teams.

Key Responsibilities

• Lead the operational planning and execution of clinical trials from study start up through close out

• Develop and maintain clinical trial plans, timelines, and tracking tools

• Ensure trials are conducted in accordance with study protocols, SOPs, ICH GCP, and applicable regulations

• Coordinate site selection, initiation, monitoring, and close out activities

• Oversee protocol deviations, corrective and preventive actions (CAPAs), and risk mitigation strategies

• Ensure compliance with regulatory and ethical bodies

• Support regulatory submissions, approvals, and ongoing communications with authorities

• Ensure informed consent processes and participant protections are rigorously upheld

• Supervise Clinical Research Associates (CRAs) and other study team members

• Provide training, mentorship, and performance oversight for assigned staff

• Manage third party vendors (e.g., laboratories, imaging providers, logistics vendors)

• Facilitate cross functional collaboration with data management, pharmacovigilance, and quality teams

• Act as the primary point of contact for sponsors and principal investigators

• Lead study meetings, status calls, and investigator meetings

• Provide regular progress reports, risk assessments, and issue escalation to leadership

• Ensure accurate and timely trial documentation, including TMF completeness

• Support audit and inspection readiness and responses

• Promote a culture of continuous quality improvement and operational excellence

Required Qualifications

• Bachelor’s degree in Life Sciences, Health Sciences, Pharmacy, Medicine, or a related field

• Minimum 5–7 years of clinical research experience, with at least 2–3 years in a clinical trial management or lead role

• Strong working knowledge of ICH GCP, clinical trial operations, and drug/device development

• Demonstrated experience managing trials in Sub Saharan Africa, preferably in Nigeria

• Familiarity with NAFDAC and NHREC regulatory processes

Preferred Qualifications

• Master’s degree in Public Health, Clinical Research, Regulatory Science, or related discipline

• Experience working within a CRO or biopharma environment

• Experience managing multi site or multi country African clinical trials

• Professional certification (e.g., ACRP, SOCRA)

Key Skills and Competencies

• Strong leadership and team management skills

• Excellent organizational and problem solving abilities

• High attention to detail and quality standards

• Effective written and verbal communication skills

• Ability to manage multiple studies and priorities simultaneously

• Willingness to travel to clinical sites across Africa

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