Senior Clinical Trial Manager

Senior Clinical Trial Manager

Location: Johannesburg

Reference: JR162011

About the role

Senior Clinical Trial Manager

Location

Johannesburg

What You Will Do: In this role, you will be responsible for the end-to-end operational delivery of clinical studies at country level, from feasibility and site selection through to study close-out and archiving.

Key responsibilities include:

• Lead and coordinate local study teams, including CRAs and Clinical Study Administrators, to deliver studies according to agreed timelines, budgets and quality standards
• Oversee country and site-level study activities, including feasibility, site identification, qualification, start-up, initiation, monitoring, close-out and archiving
• Coordinate timely ethics committee, IRB and regulatory submissions in collaboration with Regulatory Affairs, ensuring compliance with local requirements
• Manage country-level study plans, budgets, contracts, informed consent documentation, investigational product activities and essential study documentation
• Oversee site monitoring activities, review monitoring visit reports and conduct co-monitoring, accompanied site visits or training visits when required
• Proactively identify and manage study risks, recruitment challenges and operational issues, working with sites, vendors and local and global stakeholders to implement appropriate solutions
• Maintain inspection-ready study documentation and systems, including the CTMS and eTMF, and support audit and regulatory inspection activities

Your Profile: To succeed in this role, you will bring strong clinical trial management and site monitoring experience, together with the leadership and project management capabilities required to deliver complex clinical studies.

Required qualifications and experience:

• A bachelor’s degree in life sciences or another relevant discipline is essential
• A minimum of five years’ clinical trial management experience, as well as previous experience working as a Clinical Research Associate, coupled with strong Project Management experience
• Strong knowledge of ICH-GCP, the clinical study process, drug development and applicable local regulatory requirements
• Demonstrated experience leading cross-functional study teams and managing timelines, budgets, resources, risks and competing priorities
• Excellent communication, stakeholder management, organisational and problem-solving skills, with the ability to travel nationally and internationally as required
• Must be based in Johannesburg or within a reasonable commuting distance
• Willing and able to travel to the Johannesburg office, as well as nationally and internationally, as required

Hybrid

What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion and belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Are you a current ICON Employee? Please click here to apply

Location

Johannesburg

Reference: JR162011

Categories Clinical Trial Management

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Note: This description reflects the role and requirements as provided. It may be subject to change.