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Clinical Study Manager
Il y a 4 mois
In this role you will have the opportunity to be focussed on m aximizing site performance and site engagement for your clinical studies. You will be sharing your strong clinical operational and therapeutic expertise (scientific, clinical, disease states, and treatment alternatives knowledge within the therapeutic area(s)) to support the execution of the clinical studies.
We are eager to welcome enthusiastic candidates, that are driven by science and clinical trials to create a better future for the patient.
You will be responsible for the planning, initiation, coordination and management of all monitoring and monitoring-related activities as well as for the supervision of all site-related activities:
- Develop, communicate, and execute Site Engagement Strategy/Plan
- Support the clinical team in coordinating and executing site engagement activities
- Engage, evaluate and develop a global network of high performing sites
- Develop & maintain relationships with site engagement organizations; assist in identification of high performing sites and key opinion leaders
- Interact/train new investigators to work on our clinical trials
- Responsible for all kinds of site visits and sites’ performance regarding set-up, conduct and data collection
- Primary contact for sites regarding study-related issues.
- Responsible for the early engagement with Key Opinion Leaders (KOLs)/ sites / patients organizations and key contact point for these throughout the study.
- Interact/train new investigators to work on clinical trials.
- Attend key therapeutic trainings/meetings and/or industry trainings.
- Support CPM in management of the study ( Vendor management, Training, Logistics, Selection of sites, Maintenance of study tracking, Oversight of eTMF)
- Close cooperation with the Clinical Project Managers and members of the Clinicial Trial Teams to inform on all aspects of the clincial trial status at site.
- Ensure appropriate engagement and communication with internal stakeholders regarding site visits and related activities.
- Support the development of key study documents
- Prepare and/or review monitoring tools, e.g. monitoring manual
- Support CRO/vendor selection activities and provide input in development of contract specifications regarding monitoring activities for clinical trials.
- Review and approval of site regulatory packages
- Prepare or review responses to questions from Regulatory Authorities and IRBs/ECs.
- Train appropriate internal and CRO personnel on trial-specific monitoring requirements
- Track monitoring activities including review of regulatory package status, visit reports, queries (nature and frequency), and ensure timely collection of the data.
- Conduct co-monitoring visits with internal or CRO personnel
- In collaboration with CPM/study team, ensure that the study is audit/inspection ready at all times
- Minimum of Bachelor level in life sciences degree
- A minimum of 5 years of experience in the Pharmaceutical, Biotechnology, and/or CRO industry is required with a preference towards individuals who have experience in site engagement or an investigator facing role
- You are strong in collaboration and facilitating work, processes,...
- You have excellent verbal, written and presentation skills with excellent command of English and local languages
- Able to work independently, within a great and colloborative team
- You are flexible, curious and driven
ICON's Offer:
- Dedicated Line Manager as of the first day
- Development opportunities and guided career path
- Competitive salary with extra-legal benefits, company car, home set-up allowance
- Homebased contract with the option to work from the client's office
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.
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