Senior Clinical Trial Manager

As a Senior Global Clinical Trial Manager(South Africa based), you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. You will be a part of ICON Strategic Solutions, embedded to a sponsor.

What you will be doing:

• The Sr. Clinical Trial Manager is responsible for the execution of 1 or more trials in early or late-stage development. They are also the Subject Matter Expert regarding operational aspects. This includes preparation and processing of national and international projects under consideration of the local laws, international guidelines (ICH GCP) and applicable SOPs, as well as performing activities such as leading the cross- functional operational study team lead, independent oversight of third-party providers, ensuring the study is on time with good quality.
• Escalating risks and issue
• Timely problem and issue resolution across departments.
• Facilitates study and related meeting Schedules and coordinates meetings, prepares and reviews agendas, presentation materials and minutes for study team meetings or other meetings as delegated.
• Support the global clinical protocol development process in collaboration with the Clinical Operations Management and the Medical Monitor: Contribute to the development of global clinical protocols, amendments and related documents; drive and/or contribute to the development of trial-related documents and processe
• Lead the global development of study tools, guidelines, and training materials to support effective and accurate execution of clinical trial activitie
• Develop relationships with global Investigators and Site Staff as primary contact for clinical conduct of the trial.
• Under the guidance of Clinical Operations Management, manage global study start-up activities including regulatory documents, budget, and clinical trial agreements.
• Participate in the ongoing review and cleaning of the clinical trial data.
• Chair study team meetings, collecting input from all functional lines.
• Participate in global site identification, attending PSVs and SIVs as necessary.
• Assist in the management of 3rd party vendors, including CRO, central lab and imaging vendor
• Manage global tracking, logistics and quality operations for biological samples supporting clinical trials from collection to analysis ensuring that sample inventories are accurate, complete, and up to date through effective interactions with global internal teams, sites, central reference labs, specialty lab partners, external collaborators and third-party vendors.
• Ensure global GCP QA compliance for the lifecycle of your project.
• Communicate with management to ensure transparency throughout the course of the trial(s) regarding study metrics and overall statu
• Participate in global process improvement projects.
• Ability to work independently as a senior associate.

Requirements:

• A Bachelor’s degree in the life sciences or a university degree in a related field
• Minimum 5 years of experience in pharmaceutical/biotech or related industry.as a Clinical Study Manager, coupled with prior experience as a Clinical Research Associate, with at least 3 years managing a cross functional team for study execution (Phases 1-3).
• Knowledge and experience working with legislation and international guidelines (ICH-GCP) for the performance of clinical research projects. Experience with regulatory inspections or internal process audits. Exposure to responses to Health Authority and Ethics committee questions.

Why 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.

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.

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, colour, 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.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

#LI-SB1
#LI-Home-based