ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
With our patients at the centre 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.
The role: Participates in site feasibility and/or pre-trial site assessment visits, providing recommendation from local area about site/investigator selection in collaboration with the trial team.
Acts as primary local company contact for assigned sites for specific trials.
Attends/participates in investigator meetings as needed.
Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/WIs/IFUs and policies.
Ensures site staff is trained and the corresponding training records are complete and accurate at any time point during all trial phases.
Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct.
Ensures that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents.
Maintains complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS, eTMF/IF, Trial Master Source and Sharepoints).
May be assigned as a coach and mentor to a less experienced site manager.
May contribute to process improvement and training.
Leads and/or participates in special initiatives as assigned.
May assume additional responsibilities or special initiatives such as "Champion" or Therapeutic Area Expert.
To be successful in the role, you will have: A minimum of a BA/BS degree is required. A degree in a health or science related field is preferred.
Minimum 5 years of independent monitoring experience is mandatory.
Must have experience in Clinical Research or equivalent qualification.
Specific therapeutic area experience may be required depending on the position.
Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home.
Proficient in speaking and writing the country language and English.
Good written and oral communication 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.
Various annual leave entitlements
A range of health insurance offerings to suit you and your family's needs
Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 through the form below.
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.
#J-18808-Ljbffr
