Clinical Trial Manager II (Sponsor dedicated) South Africa, Bloemfontein

Clinical Trial Manager II (Sponsor dedicated) South Africa

Job Responsibilities

Develop and coordinate Phase 1 - 4 clinical research studies, ensuring all aspects of the study are meticulously planned and executed

Implement clinical research protocols and ensure compliance with regulatory requirements, including Good Clinical Practice (GCP) guidelines

Collaborate with principal investigators, research subjects, client teams, and clinic operations teams to facilitate smooth communication and coordination

Plan and manage logistics and resource usage for clinical trials, including scheduling, budgeting, and resource allocation

Track study progress and ensure alignment with project milestones, client deliverables, and budget, providing regular updates to stakeholders

Prepare and present study reports and updates to stakeholders, including detailed analysis of study data and progress

Ensure adherence to global and regional regulations and guidelines, staying up-to-date with any changes or updates

Provide guidance and support to lower-level professionals and team members, fostering a collaborative and supportive work environment

Identify and resolve any issues or challenges that arise during the course of the study, ensuring timely and effective solutions

Maintain accurate and comprehensive documentation of all study-related activities, ensuring transparency and accountability

Qualifications

Bachelor's degree in a related field (e.g., life sciences, clinical research)

Minimum of 3 years of experience in clinical trial management or a related field

In-depth knowledge of clinical research processes and regulations

Strong project management and organizational skills

Excellent communication and interpersonal skills

Ability to work independently and as part of a team

Proficiency in using clinical trial management software and tools

Certifications

Certified Clinical Research Professional (CCRP) or equivalent certification preferred

Necessary Skills

Strong analytical and problem-solving skills

Attention to detail and accuracy

Ability to manage multiple projects and priorities simultaneously

Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)

Knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements

Summary Roles within the Clinical Trial Management job family at the P22 level are responsible for overseeing the development, coordination, and implementation of Phase 1 - 4 clinical research studies at the organization's facilities. Individuals in these roles collaborate closely with the principal investigator, serve as liaisons between research subjects, client teams, investigators, and clinic operations teams, and meticulously plan logistics and resource usage. These roles require tracking study progress in alignment with project milestones, client deliverables, and budget, while ensuring compliance with applicable regulations globally and by region. Impact and Contribution Roles within the Clinical Trial Management job family at the P22 level significantly impact the success of clinical trials by ensuring that all aspects of the study are meticulously planned and executed. Individuals in these roles contribute to the design, implementation, and delivery of processes, programs, and policies, leveraging their in-depth knowledge and skills within the professional discipline. By managing processes and potentially directing the work of lower-level professionals, these roles ensure that clinical trials are conducted efficiently and effectively, ultimately contributing to the advancement of medical research and the development of new treatments.

Core Focus

Overseeing the development and coordination of Phase 1 clinical research studies

Collaborating with principal investigators and serving as liaisons between various stakeholders

Planning logistics and resource usage for clinical trials

Tracking study progress in alignment with project milestones, client deliverables, and budget

Ensuring compliance with global and regional regulations

Contributing to the design, implementation, and delivery of processes, programs, and policies

Managing processes and potentially directing the work of lower-level professionals

Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

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