Icon plc is a world-leading healthcare intelligence and clinical research organisationFrom 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 successIcon people have a mission to succeed and a passion that ensures what we do, we do well.
Responsibilities
The start up project manager is responsible for defining, developing and delivery of the global study start up project plan by partnering with study manager, clinical trial application group, clinical research site assistants, cro study start up and site operations relationship lead and others as required for phase 3 and other supported studies
Partner with study optimization to leverage site intelligence to inform the start up project plan.
Partner with the targeted site investigator network strategy implementation lead to ensure accelerated start up strategies are leveraged at targeted sites.
Partner with clinical trial application and cro start up functions to align all country and site activities to start up project plan
Identify risks to site activation and develop mitigation plansThis role is also accountable for resolution of site activation escalations for study teams including offering options for mitigation (both at the study and site level).leader of the start up sub team and a core member of the study management operations sub team.
Ad-hoc member of the core team meeting throughout study start up.
Accountable for startup of sites to be ready to enroll.
Responsibilities
Leader of the site activation sub team and a core member of the study management operations sub team
Lead the cross functional site activation team – internal plus cro, utilizing the appropriate team members to support implementation of the start up project plan.
Ensure accelerated start-up for targeted sites leveraging the site relationship partners and site activation partners.
Drive delivery of all targeted and cro supported sites that are “ready to enroll” to the start up project plan.resolve escalated issues identified by the site activation subteam in partnership with the study manager through the study management operations subteam with the cro.
Oversee and drive execution of study start-up activity at cro.
Accountable for defining, developing and delivery of the global study start up project plan, including:
Track and communicate with study management operations subteam & core teamDrive alignment of cro study start up plan to country and site level.
Agree to deliverables on a site-level basis with the cro and monitor adherence to thesePromptly recognize and remediate potential delays, and escalate non-performance as needed.
Use site activation reporting tool following site id, up to and including, site ready to enroll, incorporating input from dcsm regulatory submission/approval timelines in order to achieve agreed upon milestones in dvso.
Implement strategies within study start up subteam on assigned study to ensure consistent and efficient communications internally and with the cro.
For pfe targeted sites, drive the site relationship partner to manage site activation timelines across targeted sites to the level of the individual site:
Understanding critical path activities at the site level
Ensure planning for individual components of iip documentation (including site contracts and budgets and icd) in partnership with cro start up and/or clinical research site assistants.
Ensure site readiness activities are considered in the overall timelines for each site to ensure ready to enroll
Supplies on site (ip and non-clinical supplies)
Systems access
Training (break blind, systems training, etc.)
Translations
Leverage all available intelligence to inform the study start up strategy:
Partner with site intelligence to ensure clear communication of data.
Obtain cro, cta, country and targeted site level input to plans.
Identify risks to site activation and develop mitigation plans, including providing input to sciops materials:
Identify and capture key risks to site activation for inclusion in sciops presentations.
Develop site activation mitigation plans and monitor effectiveness through study start up subteam.
Identify improvements and efficiencies to site activation processes and share lessons learned broadly with key stakeholders
Qualifications
Education: undergraduate degree or its international equivalent preferably in clinical, science, or health-related field from an accredited institution; a licensed health-care professional, i.e., registered nurse
Experience required: 8 years of relevant experience minimum 5 years of experience in clinical research, including a minimum of 2 years full service project management experience or an equivalent combination of education and experience sufficient to successfully perform the key responsibilities of the job.
Benefits of working in icon:
Our success depends on the knowledge, capabilities and quality of our peopleThat’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.
At 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 programsIn 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.
Icon, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassmentAll 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.
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