Accountable for the proficient and proactive co-ordination of all necessary activities required to achieve timely site activations and maintenance tasks for any given site(s) across multiple studies. Act as site liaison and escalation point of contact; proactively resolving issues to ensure the site receives a positive customer experience. Ensure Critical Document Package (CDPs) and Site Activation approval dates are forecast and planned accurately in ICON’s systems, documenting all risks to delivery with mitigations taken, as they occur. Collect and collate site CDPs for review and approval prior to site activation in accordance with all requirements, while ensuring the highest quality, accuracy and completeness of site and country documentation is obtained in the Trial Master File.
Recognize, exemplify and adhere to ICON's values, of Accountability and Delivery, Collaboration and contribute to the “Own It” culture.
Proficient knowledge of ICON SOPs/WPs, ICH/GCP and applicable country regulations/guidelines and ICON systems.
Accountable for the proficient and proactive co-ordination of all necessary activities required to achieve timely site activations and maintenance tasks for any given site(s) across a single or multiple studies.
In collaboration and feedback from the site, ensure CDP and Site Activation approval dates are forecast and planned accurately in ICON’s systems, documenting all risks to delivery with mitigations taken, as they occur.
For specific projects, may serve as the main point of contact with the FSA Project Manager or Clinical Trial Manager, other functional leads and third parties.
Work with key stakeholders to optimize performance and collaborate to ensure successful project outcomes.
Drive CDP and site activation timelines and ensure they are reflected accurately in ICON’s systems and are achieved; proactively follow through for achievement to plan; provide risk assessment and contingency plans at a site level, to mitigate impact if forecasted timelines are at risk; escalate issues as soon as identified.
Ensure timely submission of protocol and study documents/safety reports for local ethics/IRB approval according to local requirements.
Provide support, with the preparation and supply of site documentation required for regulatory submissions.
Accurate site and country adaptation and customizations of Patient Informed Consents
May be involved in the proficient negotiation of Clinical Trial Agreements (CTA), budgets and ancillary agreements, establishing and maintaining effective and proactive communication with the site regarding the status of the CTA execution plan.
Prepare, collect and collate all requirements for site CDPs for review and approval prior to site activation in accordance with ICON SOPs/WPs, Sponsor requirements, applicable country regulations/guidelines and the principles of ICH/GCP, ensuring the highest quality, accuracy and completeness of site and country documentation is obtained in the TMF.
Coordination, verification and back translation of all necessary translations required for any start-up or maintenance documentation.
Serve as internal expert consultant in regards to assigned key Institutions and sites to build relationships and internal data repository.
Proficiently perform timely and accurate site status progress communications and data entries into the appropriate tracking/management systems.
Proactively escalate issues as soon as they are identified.
May be involved in the Site Selection tasks and qualification of a given site.
Act as site liaison and escalation point of contact; proactively resolving issues to ensure the site receives a positive customer experience. Work with key stakeholders to optimize performance and
to ensure successful project outcomes
Communicate all relevant Sponsor / FSA Project Manager /Country / CTM instructions or updates to the Site
Assume responsibility as Subject Matter Expert (SME) for the required topics, ensuring knowledgeable and updated in any changing regulatory requirements.
Attend study team meetings as required
Support key initiatives, process improvement, efficiencies and technological development to meet KPIs and delight customers, sites, and team members
Responsible for performing activities that are in compliance with applicable corporate and departmental policies, standard operating procedures and operating guidelines and performing other duties as assigned by the management
Other duties as assigned.
Mentor and train other personnel in the CDP Review Team in Study Start Up department on relevant processes and activities, as assigned.
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
