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 organizations.
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.
General Summary
The Start-Up Lead (SUL) leads regional clinical study start-up activities to ensure successful activations of investigative sites in accordance with protocol, budget, standard operating procedures, policies and applicable regulations. Ensures optimal quality delivery for assigned sites’ readiness to enroll, meeting sponsor satisfaction to timelines. Proactively identifies and mitigates risks and resolves issues, escalating appropriately.
- Implements the project start-up methodology, to include project parameters, subject recruitment months and high-level study start-up activities/statuses) and documents the information within the Project Start-up Plan (PSP), CTMS and the Project Start-up Summary.
- Creates, maintains and facilitates Sponsor Approval of project documents related to study start-up, including the Essential Document Templates, Essential Document Review Requirements, Country and Site Standard Investigational Product Release forms.
- Creates, maintains and facilitates Client Approval of project status reports.
- Prepares and presents a project-specific overview to Clinical Operations, Investigator Grant Management and Global Regulatory Affairs staff regarding start up deliverables, timelines and processes.
- Oversees site identification and recruitment activities for allocated countries; including, liaising with other departments when additional sites are needed, and escalates delays, where applicable.
- Oversees the Local Regulatory Affairs Lead (LRAL), Contracts Associate (CA) and In- House Clinical Research Associate (IHCRA) to ensure that essential documents for allocated regions are developed, collected, reviewed and tracked according to the processes and timelines agreed upon on the project.
- Collaborates with the Global Regulatory Affairs Lead (GRAL) assigned to the project to ensure Ministry of Health (MoH), Central Independent Ethics Committee (IEC) and other central submissions are performed in line with site activation timelines.
- Collaborates with the GRAL and Clinical Team Manager (CTM) assigned to the project to ensure importation, exportation, insurance, labeling of Investigational Product (IP) and any other country requirements are met to ensure the timely activation of trial sites.
- Oversees Local Ethics Committee (IEC) and other local authority submissions and approvals for their country/region or the project as applicable.
- During Start-Up, works with GRAL/ LRALs and/or IHCRA(s) to ensure quality amendments and submissions are made (where applicable).
- Performs Independent QC of Investigational Product Release packages and other documentation (i.e. Essential Documents and Informed Consent Forms) as determined by project specific process.
- Oversees system compliance from the IHCRAs and works with the GRAL and/or CTA Lead to address any system compliance issues from the LRAL/CA.
- Serves as primary liaison and primary point of escalation for project start-up issues for assigned countries.
- Conducts meetings to ensure all relevant team members are properly trained on start-up activities and kept current on timelines, clinical activities and contract and budget status.
- Uses available tools, including but not limited to the Critical Chain Methodology tool to establish site activation forecasts and ensures critical path activities are on target. Also oversees the completion of the system’s activities with the support of the CTM, GRAL and CTA Lead where necessary.
- Escalates risks to project start-up timelines for assigned countries and works with the CTM and/or Project Manager (PM) to mitigate those risks.
- For assigned countries, provides timely status reports on project start-up activities for internal and client teleconferences, and during monthly project review meetings with the SSU VP, Directors and Managers.
- With support from the CTM, ensures Time Entry Guidelines are adhered to by the IHCRA, determines worked hours and analyzes forecasted and worked activities to ensure adherence to contract and budget.
- Assesses and communicates impact of project scope on timeline changes and/or local resource requirements and escalates where necessary.
- Assists the CTM, CTA Lead, GRAL and/or PM with the forecast of units and hours and generic resourcing for IHCRA, LRAL and CA activities; determines worked units and hours and analyzes forecasted and worked activities to ensure adherence to contract and budget, as required.
- Facilitates the transition of study activities and status to the CTM and Clinical Research Associate (CRA) as sites/countries move out of Start-up and into Conduct.
Benefits of Working in ICON:
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.
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 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.
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, 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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