Vacancy expired!
The Clinical Trial Manager will act as the Functional Lead from Clinical Research Services with responsibility for delivery of all clinical aspects of clinical studies. To oversee and serve as the liaison between the Project Manager and a group of Clinical Research Associates (CRAs) assigned to a given clinical study for the delivery of all aspects of monitoring and site management, ensuring consistency with ICH/GCP and applicable ICON Standard Operating procedures (SOps), applicable regulations, the Monitoring and ensuring the clinical portion of the study is inspection ready at all times.What you will be doing:
Responsible for planning, scheduling and implementing the clinical aspects of projects in line with contract and budget.
Responsible for driving enrolment as per contracted timelines.
Regular oversight of key clinical metrics.
Oversight of visit report review and approval, including site issue escalation and resolution.
Responsible for co- coordinating, managing and mentoring the clinical project team.
Active involvement in clinical risk planning and assessment, developing mitigation strategies and associated action plans, issue escalation and resolution
Responsible for the development and maintenance of operational plans.
Ensure all closeout activities are completed as necessary.
Ensure timely dissemination of information on study progress or issues and/or processes to all team members related to clinical deliverables and accurate tracking of any relevant study information related to clinical deliverables.
Develop a succession plan for clinical study team members and, in the event of a change to the team, ensure an effective hand-over that is appropriately documented.
Participate in business development activities including bid defence meetings; may be required to provide input to the clinical strategy.
You are:
4 year degree or equivalent combination of education & experience
4+ years of experience of relevant experience is required, including monitoring, and/or site management activities, and supporting of clinical trial management activities.
Demonstrated ability to drive the clinical deliverables of a study
Strong understanding of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment and medical terminology.
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-JK1
