Clinical Research Site Manager

Pillangó Placements; East London; On-site; ZAR 300,000 - 400,000; Full time

Job summary

A leading health organization in East London seeks an experienced Clinical Research Lead to oversee multiple clinical trials and manage staff. The ideal candidate will have a Master's in a Biomedical field, at least 5 years of clinical trial management experience, and strong community engagement skills. This role focuses on enhancing health priorities through research and contributing to scientific publications.

Qualifications

• Master’s Degree in a Biomedical/Health related field is essential.
• Current registration with the Health Professions Council of South Africa, if applicable.
• Minimum of 5 years’ experience managing clinical trials is essential.

Responsibilities

• Lead and oversee multiple clinical studies adhering to GCP and sponsor standards.
• Monitor study performance and maintain essential documents.
• Supervise and mentor site staff to uphold high research standards.

Skills

Clinical Trial Management

Staff Supervision

Community Engagement

Microsoft Office Proficiency

English Proficiency

Education

Master’s Degree in Biomedical/Health field

Management qualification

PhD in Biomedical/Health field

Project Management qualification

Tools

GCP certification

Job description

Are you an experienced professional in the field of Clinical Research who is deeply passionate about contributing to the South African community and committed to making a meaningful impact and taking on a leadership role?

Become part of an organisation dedicated to driving social change and take responsibility for a research site in East London, conducting clinical trials and various projects focused on community engagement, skill development, and alignment with health priorities.

KEY SUMMARY OF POSITION:

(For the sake of brevity and easy reading, only a key summary of the full job specification / job advert as provided by the client is provided below. Additional information and full details regarding the position and potential employer will be provided following our initial contact and the CV review)

PROJECT MANAGEMENT

• Lead and oversee multiple clinical studies, ensuring adherence to GCP, protocols, SOPs, and sponsor/internal standards; standardize study processes across planning, activation, recruitment, data management, and closeout phases.
• Monitor study performance, address findings from monitoring reports with PIs, maintain essential documents, provide stakeholder updates, engage with communities, and contribute to SOP development.

SITE MANAGEMENT

• Oversee daily clinic operations, including staff allocation across studies, performance evaluation, and prompt recruitment to ensure optimal site performance and resource availability.
• Act as the main point of contact for sponsors and stakeholders, and support study feasibility assessments by providing insights on site capabilities, patient demographics, and logistics.

STAFF TRAINING & MENTORSHIP

• Supervise, mentor, and support site staff to uphold high research standards, including training based on quality and monitoring feedback.
• Promote professional development by guiding staff in scientific writing, presentations, and ongoing skill enhancement.

RESEARCH OUTPUTS

• Lead and contribute to scientific publications and research dissemination.
• Lead or significantly contribute to writing of grant proposals

QUALIFICATIONS AND REGISTRATION

• Master’s Degree in a Biomedical/Health related field (essential).
• Current registration with the Health Professions Council of South Africa, if applicable.
• Management qualification (essential).
• PhD in a Biomedical/Health related field (advantageous).
• Project Management qualification (advantageous).
• Valid GCP certification (advantageous).

EXPERIENCE

• Minimum of 5 years’ experience managing clinical trials (essential).
• Minimum of 3 years demonstrated experience in clinical research site management and leading site research teams (essential).
• Comprehensive understanding of the current regulatory requirements pertaining to clinical trials (essential).
• Experience with regulatory submissions to SAHPRA, Ethics Committees, and other regulatory authorities (essential).
• Study trial document development including protocols, case report forms, and SOPS.
• Contribution to scientific publications and grant proposals.

OTHER REQUIREMENTS

• Proficiency in reading, speaking, and writing English.
• Proficiency in reading, speaking, and writing Xhosa (advantageous).
• Proficiency in Microsoft Office.
• Embracing and leveraging Artificial Intelligence (AI), to enhance operational efficiency.
• Willingness to work reasonable flexible hours, including weekends, if required, in accordance with the BCEA.
• Valid driver’s license (essential).

SALARY

This role is open to candidates at varying levels, and the final remuneration package will be tailored to reflect your individual qualifications, skills, and experience.