Website ICON Strategic Solutions
ICON Strategic Solutions is a globally recognized healthcare intelligence and clinical research organization specializing in providing outsourced services to various sectors within the healthcare industry. With a comprehensive range of services, ICON supports pharmaceutical companies, biotechnology firms, medical device manufacturers, government agencies, and public health organizations in advancing clinical research and drug development initiatives.
The company’s primary objective is to accelerate the journey from initial molecule discovery to the development of life-saving drugs and medical devices. By leveraging its expertise and resources, ICON aims to streamline the clinical trial process, improve efficiencies, and ultimately bring innovative treatments to market faster.
Key aspects of ICON’s profile include:
- Healthcare Intelligence and Clinical Research: ICON is at the forefront of healthcare intelligence and clinical research, offering a broad spectrum of services to support the entire clinical trial lifecycle. From protocol design to site selection, patient recruitment, data management, and regulatory submissions, ICON provides comprehensive solutions tailored to meet the unique needs of each client.
- Patient-Centric Approach: Central to ICON’s operations is a commitment to prioritizing patient well-being and safety. The company ensures that patients remain at the heart of all clinical research activities, emphasizing ethical conduct, informed consent, and adherence to regulatory standards.
- Global Reach: With a presence in numerous countries worldwide, ICON boasts a global network of experienced professionals who collaborate seamlessly to execute clinical trials across diverse geographical regions. This global footprint enables ICON to access a wide range of patient populations and therapeutic expertise, facilitating the efficient conduct of multinational trials.
- Culture of Excellence: ICON values its people as its greatest asset and fosters a culture of excellence, innovation, and collaboration. The company invests in talent development, providing employees with opportunities for growth, training, and professional advancement. This commitment to employee satisfaction contributes to a motivated workforce dedicated to achieving outstanding results.
- Strategic Solutions: As a leader in functional service provision (FSP) models, ICON offers strategic solutions that optimize clinical trial operations, drive cost savings, and enhance business performance for its clients. By combining functional expertise, operational excellence, and talent management, ICON delivers customized FSP solutions tailored to address specific client needs and challenges.
Job Position: Clinical Trial Manager
Location: Hybrid (South Africa & Sub-Saharan Africa)
The profession of Clinical Trial Manager (CTM) is a crucial role within the field of clinical research and drug development. CTMs play a pivotal role in overseeing the planning, implementation, and management of clinical trials, ensuring they are conducted efficiently, ethically, and in compliance with regulatory requirements. Here’s a more detailed explanation of the profession:
- Responsibilities: Clinical Trial Managers are responsible for managing all aspects of clinical trials, from the planning phase to study close-out. This includes developing study protocols, designing study documents, recruiting and training study personnel, monitoring study progress, managing study budgets and timelines, ensuring regulatory compliance, and overseeing data collection and analysis.
- Site Management: CTMs establish and maintain relationships with investigational sites, serving as the primary point of contact between the sponsor company and the study sites. They conduct site feasibility assessments, negotiate contracts and agreements with sites, provide ongoing support and training to site personnel, and ensure that sites adhere to study protocols and regulatory requirements.
- Vendor Oversight: CTMs often work closely with external vendors, such as Contract Research Organizations (CROs) and laboratory services, to support various aspects of clinical trial conduct. This may involve selecting vendors, negotiating contracts, managing vendor performance, and ensuring that vendors deliver high-quality services within agreed-upon timelines and budgets.
- Risk Management: CTMs identify and mitigate risks that may impact the successful execution of clinical trials. This includes anticipating potential challenges, such as enrollment delays, protocol deviations, or regulatory issues, and implementing strategies to address them proactively. CTMs also monitor key performance indicators and metrics to assess study progress and identify areas for improvement.
- Regulatory Compliance: Ensuring compliance with regulatory requirements is a critical aspect of the CTM role. CTMs must have a thorough understanding of Good Clinical Practice (GCP) guidelines, International Council for Harmonisation (ICH) guidelines, and local regulatory requirements governing clinical research. They are responsible for ensuring that study conduct and documentation meet these standards to protect patient safety and data integrity.
- Team Collaboration: CTMs collaborate closely with cross-functional teams, including clinical operations, data management, regulatory affairs, medical affairs, and biostatistics, to coordinate and execute clinical trials effectively. They serve as leaders and facilitators, ensuring clear communication and alignment across team members to achieve study objectives.
- Professional Development: The field of clinical research is dynamic and continuously evolving, requiring CTMs to stay abreast of emerging trends, regulations, and best practices. Many CTMs pursue professional development opportunities, such as certifications (e.g., Certified Clinical Trial Manager), continuing education programs, and industry conferences, to enhance their knowledge and skills.
ICON is seeking a highly motivated and experienced individual to join our team as a Clinical Trial Manager. This position offers the opportunity to work remotely and collaborate with global teams in overseeing site-level study start-up, conduct, and close-out activities for clinical trials across various therapeutic areas. The successful candidate will play a crucial role in building and maintaining site relationships, ensuring compliance with regulatory requirements, and driving the successful delivery of clinical trials.
In addition to a competitive salary, ICON offers a range of benefits designed to promote well-being and work-life balance. These benefits include:
- Various annual leave entitlements
- Health insurance offerings tailored to suit you and your family’s needs
- Retirement planning options to maximize savings and ensure financial security
- Global Employee Assistance Programme providing access to a network of specialized professionals for support
- Life assurance coverage
- Flexible country-specific optional benefits, such as childcare vouchers, gym memberships, and health assessments
To be considered for this position, candidates must meet the following criteria:
- Minimum of 8 years of experience in clinical development/operations, including at least 3 years of experience in oversight of vendors and project management
- Detailed understanding of clinical protocol design and implementation, site monitoring, and global drug development processes
- Expert knowledge of clinical development principles, regulatory requirements (e.g., ICH GCP), and applicable regional/local regulations
- Background in Medical or Life Sciences with a focus on clinical research or equivalent qualification
Interested candidates should submit the following documents along with their application:
- Curriculum Vitae (CV)
- Cover Letter outlining relevant experience and qualifications
- Contact details of at least two professional references
How to Apply:
To apply for this position, please submit your application through the ICON LinkedIn. For any inquiries regarding the application process or the position itself, please visit our website.
The deadline for applications is not available.
For further information about ICON Strategic Solutions and career opportunities, please visit our website: https://careers.iconplc.com/.
To apply for this job please visit www.linkedin.com.