Clinical Trial Manager

2 weeks ago

Johannesburg, Gauteng, South Africa ICON Full time

Clinical Trial Manager

Location - hybrid (Johannesburg, South Africa)

Sponsor dedicated


As a Clinical Trial Manager you will be joining the world's largest & most comprehensive clinical research organizations, powered by healthcare intelligence.


As a single sponsor-dedicated Clinical Trial Manager, you will have an opportunity to work in a solid partnership and an environment driven by innovation and continuous improvement.

This program is for you if you are looking for an environment where people feel they belong and are empowered to reach their full potential, perform at their best and make a valued contribution to saving lives.


The Clinical Trial Manager (CTM) is pivotal to trial delivery and compound development, providing leadership and driving decisions related to the conduct of a clinical trial.

The CTM leads and manages the operational implementation of country feasibility, planning and delivery of clinical studies within and across therapeutic areas.

The CTM serves as the operational point-of-contact between the Central Study Team and in-country staff aligned to the study.

Accountable for high quality execution/delivery of studies within country as defined by the protocol & per agreed timelines / budget, overall project management of study activities.


As a Clinical Trial Manager, you will be leading the Local Study Team(s) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with SOPs and international guidelines such as ICH-GCP as well as relevant local regulations.


Responsibilities:

  • Collaborates with cross functional internal and external stakeholders to ensure timely execution, budget execution of clinical trial deliverables within the country.
  • Maintains expert country, site and protocol knowledge to support sites with questions as well as build strong site relationships.
  • Leads Local Study Team consisting of CRAs, CTAs, and Study Startup Specialists for assigned studies.
  • Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.
  • Ensures timely submission of documents to EC/IRB at start up and for the duration of the study.
  • Works together with Regulatory Affairs to ensure timely delivery of documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.
  • Contributes to, deliver and/or lead CRA, Investigator and Study Coordinator training.
  • Reviews monitoring visit reports and proactively advices the monitor(s) on study related matters.
  • Performs any required comonitoring, Accompanied Site Visits/training visits with study CRAs.
  • Organises regular Local Study Team meetings on an agenda driven basis.
  • Actively works towards achieving good personal relationships with all Local Study Team members, sites' staff and global stakeholders.
  • Provides input to process development and improvement.
  • Updates Line Managers about the performance of the CRAs/CSAs.
  • Ensures that study activities at country level comply with local policies and code of ethics.

Qualifications and Experience Required:

  • Minimum 5 years of experience in clinical research, including a minimum of 2 years as a Clinical Lead or CTM.
  • Excellent leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives.
  • Demonstrates an excellent understanding of the clinical study, drug development, sample management and other associated processes and quality requirements.
  • Strong Clinical Lead/Management mindset and demonstrated ability to work and lead in a matrix team environment involving both internal and external partners.
  • Solid understanding of country local regulations, ICH-GCP guidelines and company written standards.
  • Flexible and resilient with ability to evolve in changing and challenging environment.
  • Demonstrates good English language written and verbal communication skills in addition to proven negotiation skills.

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
  • Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
  • Global Employee Assistance Programme, TELUS Health, offering 24hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well

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