Senior Pharmaceutical Clinical Operations Manager

Placements24; Mbombela (Nelspruit); Hybrid; ZAR 1,200,000 - 2,000,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Retirement plan

Job summary

Placements24 is seeking an experienced Senior Pharmaceutical Clinical Operations Manager to lead global Phase I–IV trials from a remote home office. The role oversees study execution, regulatory compliance, and cross-functional collaboration with sites, CROs and internal teams.

The ideal candidate has 8+ years in clinical operations, strong GCP/ICH knowledge, and proven remote leadership skills. Advanced degree is a plus; salary is commensurate with experience.

Qualifications

• Bachelor's degree in a scientific or healthcare-related field.
• Advanced degree (MSc, PhD, PharmD) is a plus.
• Minimum of 8 years of progressive experience in clinical operations.
• Experience managing multiple complex trials from initiation to closure.
• Strong knowledge of GCP, ICH, FDA and global regulations.
• Excellent leadership and project management skills.
• Ability to work with cross-functional teams and external partners.
• Experience with EDC and CTMS systems.
• Strategic thinker; capable of identifying risks and solutions.
• Proven track record of managing remote teams in a virtual environment.

Responsibilities

• Oversee planning, execution, and monitoring of Phase I-IV trials globally.
• Manage trial budgets, timelines, and resources for success.
• Select and train investigative sites and CROs.
• Ensure compliance with GCP, ICH, FDA and regulatory requirements.
• Develop protocols, informed consent forms, and study docs.
• Oversee data management, cleaning, and analysis with data teams.
• Monitor progress, identify risks, and implement mitigations.
• Coordinate communication between sites, stakeholders, and regulators.
• Contribute to development strategies and plans.
• Mentor junior staff and study team members.

Skills

Leadership

Project management

Regulatory knowledge

Clinical operations

Remote team management

EDC/CTMS

Education

Bachelor's degree in a scientific or healthcare field

Advanced degree (MSc/PhD/PharmD)

Tools

EDC systems

CTMS

Job description

About the Role

Our client, a cutting-edge pharmaceutical company focused on developing innovative therapies, is looking for a highly experienced Senior Pharmaceutical Clinical Operations Manager to join their team on a remote basis. This critical role will oversee the execution of clinical trials, ensuring they are conducted in accordance with protocols, regulatory requirements, and ethical standards. You will manage a portfolio of studies, working with investigative sites, CROs, and internal teams to ensure timely and high-quality trial conduct. The ideal candidate possesses a strong background in clinical trial management, excellent leadership skills, and a proven ability to manage complex projects in a decentralized environment. This is a fantastic opportunity to make a significant impact on bringing new medicines to patients while enjoying the flexibility of a remote work arrangement. Join our client and lead the charge in advancing clinical research from your home office.

Key Responsibilities

• Oversee the planning, execution, and monitoring of Phase I-IV clinical trials globally.
• Manage clinical trial budgets, timelines, and resources effectively to ensure project success.
• Select, train, and manage investigative sites and contract research organizations (CROs).
• Ensure compliance with Good Clinical Practice (GCP), ICH guidelines, and all relevant regulatory requirements.
• Develop and implement clinical trial protocols, informed consent forms, and other essential study documents.
• Oversee data management activities, including data collection, cleaning, and analysis, in collaboration with data management teams.
• Monitor study progress, identify risks, and implement mitigation strategies to keep trials on track.
• Manage communication between clinical sites, internal stakeholders, and regulatory authorities.
• Contribute to the development of clinical development strategies and plans.
• Mentor and guide junior clinical operations staff and study team members.

Requirements

• Bachelor's degree in a scientific or healthcare-related field.
• Advanced degree (MSc, PhD, PharmD) is a plus.
• Minimum of 8 years of progressive experience in clinical operations within the pharmaceutical or biotechnology industry.
• Demonstrated experience in managing multiple complex clinical trials from initiation to closure.
• Thorough understanding of GCP, ICH, FDA, and other relevant global regulatory requirements.
• Strong project management skills, including budget management and timeline adherence.
• Excellent leadership, communication, and interpersonal skills.
• Proven ability to work effectively with cross-functional teams and external partners (sites, CROs).
• Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
• Ability to think strategically, identify risks, and implement effective solutions.
• Proficiency in managing remote teams and working in a virtual environment is essential.

Benefits

Our client offers a highly competitive salary and a comprehensive benefits package, including health, dental, and vision insurance, and retirement savings plans, all designed to support remote employees. Enjoy the ultimate flexibility of working from home, combined with opportunities for professional growth and career advancement within a rapidly expanding company. Our client is dedicated to fostering a diverse and inclusive remote workforce. Make a meaningful contribution to the future of healthcare by managing groundbreaking clinical trials from your home.