Clinical Trial Manager

Placements24; Cape Town; Hybride; ZAR 900 000 - 1 300 000; Plein temps

Avantages offerts par ce poste

Performance bonus

Medical aid

Retirement fund contributions

Generous paid annual leave

Professional development opportunities

Résumé du poste

Placements24 is seeking an experienced Clinical Trial Manager to oversee the execution of clinical studies. The role involves planning, implementation, and monitoring of trials, ensuring compliance with GCP and regulatory standards.

A hybrid work model is offered with required presence in the Cape Town office for key meetings. The candidate should have a Life Sciences degree (Master’s preferred) and at least 5 years of trial management experience in pharma/biotech, with proficiency in CTMS and

Qualifications

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field.
• Master’s degree or equivalent experience preferred.
• Minimum 5 years in clinical trial management in pharma/biotech.
• Strong knowledge of GCP/ICH and regulatory requirements (SA and international).

Responsabilités

• Develop and manage clinical trial protocols, budgets, and timelines.
• Select and manage clinical sites and staff.
• Oversee recruitment and enrollment of study participants.
• Ensure adherence to GCP and regulatory requirements.
• Monitor trial progress, data collection, and data integrity.

Connaissances

Project management

GCP & ICH compliance

Stakeholder management

Communication

Formation

Bachelor’s degree in Life Sciences/related field

Master’s degree preferred

Outils

CTMS

EDC systems

Description du poste

About the Role

Our client is a dynamic and growing pharmaceutical company seeking an experienced Clinical Trial Manager to oversee the execution of clinical studies. This role is crucial for bringing innovative treatments to market. You will be responsible for the planning, implementation, and monitoring of clinical trials, ensuring compliance with all relevant regulations and protocols. While this position offers a hybrid work model, allowing for a balance between remote flexibility and in-office collaboration, it requires presence in our **Cape Town, Western Cape, ZA** office for key meetings and team interactions. The successful candidate will join a dedicated team focused on advancing medical breakthroughs and improving patient outcomes. This is an excellent opportunity to lead significant projects within the pharmaceutical industry and contribute to life-changing therapies.

Key Responsibilities

• Develop and manage clinical trial protocols, budgets, and timelines.
• Select and manage clinical investigative sites and associated staff.
• Oversee the recruitment and enrollment of study participants.
• Ensure adherence to Good Clinical Practice (GCP) guidelines and all applicable regulatory requirements.
• Monitor trial progress, manage data collection, and ensure data integrity.
• Prepare and submit necessary regulatory documents and reports.
• Liaise with internal departments (e.g., R&D, regulatory affairs) and external stakeholders, including ethics committees and health authorities.
• Manage vendors and CROs involved in clinical trial execution.
• Identify and mitigate risks associated with clinical trials.

Requirements

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
• A Master's degree or equivalent experience is preferred.
• Minimum of 5 years of experience in clinical trial management within the pharmaceutical or biotech industry.
• In-depth knowledge of GCP, ICH guidelines, and regulatory requirements in South Africa and internationally.
• Proven experience in managing Phase I-IV clinical trials.
• Strong project management and organizational skills.
• Excellent communication, interpersonal, and negotiation skills.
• Ability to work effectively in a hybrid environment, balancing remote and in-office responsibilities.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.

Benefits

Our client offers a competitive salary and a comprehensive benefits package designed to support employee well-being. Benefits include a performance bonus, medical aid, retirement fund contributions, and generous paid annual leave. Employees benefit from professional development opportunities, including training and conference attendance. The hybrid work model provides flexibility, allowing for a healthy work-life balance. You will be part of an innovative and supportive work culture, contributing to meaningful advancements in healthcare. The **Cape Town, Western Cape, ZA** location provides a vibrant environment for professional growth.