Senior Clinical Trial Manager - Oncology

Placements24; Gqeberha; On-site; ZAR 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Health insurance

Relocation assistance

Professional development

Job summary

Placements24 is seeking a Senior Clinical Trial Manager for its Port Elizabeth operations to oversee oncology trials, drive timelines, budgets, and cross-functional collaboration with regulatory, data management, and vendor teams.

The ideal candidate has 7+ years in clinical trial management, extensive ICH-GCP knowledge, leadership skills, CTMS/EDC proficiency, and willingness to travel domestically and internationally.

Qualifications

• Bachelor's degree in a life science, nursing, or related field; Master's degree or advanced clinical research certification preferred.
• Minimum of 7 years of progressive experience in clinical trial management, with a significant focus on oncology trials.
• In-depth knowledge of ICH-GCP guidelines, regulatory requirements, and clinical trial methodologies.
• Proven experience in managing multiple clinical trials from initiation to close-out.
• Strong leadership and project management skills with the ability to motivate cross-functional teams.
• Excellent communication, interpersonal, and negotiation skills.
• Proficiency in CTMS, EDC systems, and other relevant software.
• Experience working with CROs and managing vendor relationships.
• Ability to travel domestically and internationally as required.
• Demonstrated problem-solving abilities and a proactive approach.

Responsibilities

• Develop and manage oncology trial protocols, study plans, and budgets.
• Oversee selection, training, and management of clinical sites and staff.
• Ensure compliance with regulatory requirements and SOPs throughout trial lifecycle.
• Monitor trial progress, mitigate risks, and implement corrective actions.
• Coordinate with regulatory, data management, medical affairs, and CROs for seamless execution.
• Build relationships with investigators and site staff in oncology.
• Prepare study documents including CRFs and safety monitoring plans.
• Oversee data collection, query resolution, and database lock procedures.
• Manage trial timelines and resource allocation.
• Contribute to clinical strategies and portfolio planning.

Skills

Leadership

Project management

Communication

CTMS proficiency

EDC proficiency

Vendor management

Travel flexibility

Problem solving

Education

Bachelor's degree in life science/nursing/related field

Master's degree or Advanced clinical research cert

Tools

CTMS

EDC systems

Regulatory knowledge tools

Job description

About the Role

Our client, a leading global biopharmaceutical company committed to advancing cancer treatment, is seeking a highly experienced Senior Clinical Trial Manager for its operations in Port Elizabeth . This crucial role will oversee the successful planning, execution, and completion of complex oncology clinical trials, ensuring adherence to the highest standards of quality, regulatory compliance, and patient safety. You will be responsible for managing cross-functional teams, site operations, and vendor relationships, driving forward innovative research that aims to improve the lives of cancer patients. This is an exceptional opportunity to contribute to life‑saving research within the dynamic healthcare sector of Port Elizabeth, Eastern Cape .

Key Responsibilities

• Develop and manage comprehensive clinical trial protocols, study plans, and budgets for oncology studies.
• Oversee the selection, training, and management of clinical investigative sites and study personnel.
• Ensure compliance with all applicable regulatory requirements (e.g., ICH-GCP, FDA, EMA) and internal SOPs throughout the trial lifecycle.
• Manage and monitor trial progress, identifying and mitigating risks, and implementing corrective actions as needed.
• Coordinate with internal departments (e.g., regulatory affairs, data management, medical affairs) and external vendors (e.g., CROs, central labs) to ensure seamless trial execution.
• Develop and maintain strong relationships with investigators, clinical site staff, and key opinion leaders in oncology.
• Prepare and review essential study documents, including Investigator's Brochures, case report forms (CRFs), and safety monitoring plans.
• Oversee data collection, query resolution, and database lock procedures to ensure data integrity and accuracy.
• Manage trial timelines, resource allocation, and operational aspects to ensure timely trial completion.
• Contribute to the development of clinical strategies and provide input into portfolio planning.

Requirements

• Bachelor's degree in a life science, nursing, or related field; Master's degree or advanced clinical research certification is preferred.
• Minimum of 7 years of progressive experience in clinical trial management, with a significant focus on oncology trials.
• In-depth knowledge of ICH-GCP guidelines, regulatory requirements, and clinical trial methodologies.
• Proven experience in managing multiple clinical trials simultaneously, from initiation to close-out.
• Strong leadership and project management skills, with the ability to motivate and guide cross-functional teams.
• Excellent communication, interpersonal, and negotiation skills.
• Proficiency in clinical trial management systems (CTMS), electronic data capture (EDC) systems, and other relevant software.
• Experience in working with Contract Research Organizations (CROs) and managing vendor relationships.
• Ability to travel domestically and internationally as required.
• Demonstrated problem‑solving abilities and a proactive approach to managing challenges.

Benefits

• Our client offers a competitive salary, a comprehensive benefits package including health, dental, and vision insurance, life assurance, and a generous retirement savings plan.
• We provide ample opportunities for professional development, including specialized training and conference attendance.
• Join a dedicated team working in a supportive environment in Port Elizabeth , contributing to groundbreaking advancements in cancer therapy.
• Our client values work‑life balance and offers attractive leave policies.
• Relocation assistance will be provided to successful candidates moving to the Eastern Cape .