Subject matter expert Jobs in Burlington, ON

Site Partner II

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

Title: Site Partner II

Role Summary:

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 receieves a positive customer experience. Ensure Critical Document Package (CDPs) and Site Activation approval dates are forecasted 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.

Responsibilities:

• 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 customisations of Patient Informed Consents

• May be involved in the proficient negotiation of 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 tanslation 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 ssues 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 knowledgable 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.

What you need:

• Bachelor's Degree

• 0-3 years of experience in a Clinical Research environment

• Good communication skills

• Good Judgment & Decision Making

• Proficient computer knowledge.

• Proficiency in English language is mandatory

• Knowledge of basic French is preferred

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.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. 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 or submit a request here

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.

Are you a current ICON Employee? Please click here to apply