L o cal Trial Manager - Oncology - Gauteng South Africa

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organization's.

With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

In this role you are responsible for leading a cross-functional study team and for providing the team with direction and guidance to enable successful study delivery. You will be the main liaison between the study team and the Clinical Program Team (CPT) starting with study handover through to close-out and archiving. You will be accountable to the CPT for the delivery of a study according to agreed upon timelines, budget and quality standards by ensuring an effective partnership and teamwork within study team and/or external partners.

• Leading of all local study teams, optimize performance, ensuring compliance with local regulations and ICH-GCP.
• Ensuring that all feasibilities are performed at maximum quality standards.
• Coordination of site selection through site and investigator identification, performing of Site Quality Risk assessments and SQV’s.
• Ensuring of all timely submission, collection and verification of all documentation throughout the study: Namely, Financial Study agreements, budgets, Master CSA, MICF, and ICF’s.
• Setting up of C T M S at study country leve
• Overseeing, maintenance, and coordination of all monitoring activities from activation to close-out.
• Consistent development and review of risk management planning, managing sites, stakeholders, vendors, and customers to ensure all risks are mitigated.
• May be required to provide co-monitoring support, and training visits with CRA’s and review of monitoring visit reports.
• Contribution to recruitment strategies for patients, and conducting regular communication with Investigators.
• Ensuring that strong relationships are created and maintained with Local team, site staff and stakeholders globally.
• Consistent progress reporting to Global Leads and teams.
• Leading of all I nvestigator meetings.
• Fo r ecasting of study timelines, resources, recruitment, budgets, and drug supplies.
• Ensuring that all systems are updated and access is granted at country level.
• Ensuring that payments are accurate and performed according to regulations and agreements
• T r aining and coaching of members of the Local Study Team ensuring compliance
• Ensuring documentation is completed and ready for inspection
• Leading and planning of all activities associated with audits and regulatory inspections
• P r o viding of input to process improvement.
• Escalation of issues to line managers on studies and timelines, as well as performance of CRA’s and CSC’s
• Collaboration with all relevant internal teams

What is Required

• Bachelor’s degree in related discipline
• A Minimum of 3 years of experience in the capacity of Trial Manager or Senior CRA, working on Oncology studies is Non-Negotiable.
• Proven ability to lead and motivate cross-functional teams to deliver clinical trials according to plan, budget and quality.
• Excellent project management, team building and interpersonal skills.
• Excellent attention to details.
• Strong negotiation skills.

Benefits of Working for ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and 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.