Clinical Development Trial Lead

Location: Blue Bell

Clinical Development Trial Lead

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.

The Clinical Development Trial Lead (CDTL) Associate leads the cross-functional study team in the development and execution of clinical trials and is accountable both regionally and globally to deliver trial(s) with quality, on time, and within scope and budget.  The CDTL Associate leverages project management, regional operational knowledge, clinical trial process leadership and expertise, and scientific expertise to drive actions and coordinate efforts to achieve or exceed these trial deliverables.

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* What You Will Do:

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* Use processes and tools to develop, execute, and deliver local, regional and/or global clinical trials as described below:

+ Scope - Understand the scope of work required to complete the clinical trial successfully. Monitor the status and make changes (per change control process) as needed to meet the deliverables of the trial.

+ Timeline - Develop and track global milestones by gaining alignment and integrating inputs across functions and geographies.

+ Risk - Assess, identify and monitor trial-level risks.  Incorporate scientific knowledge, trial process, and regional expertise to create one integrated trial-level risk mitigation and contingency plan.

+ Budget - Understand the cross-functional, trial-level budget components.  Create and monitor the grants and non-grants, and assumptions using financial tracking tools.  Routinely network with appropriate business partners on trial-level budget status and changes.

+ Partner with other organizations to coordinate and deliver Investigator Study Specific Training (ISSTs)/ Affiliate Study Training (ASTs)/Investigator Engagement Meetings.

+ Drive and coordinate local, regional and global, cross-functional study team throughout study implementation, execution and closure empowering them to meet the clinical trial deliverables, including issue management, contingency planning and issue resolution.

+ Be accountable for trial/regional enrollment strategy and execution starting from country allocation through Last Patient Entered Treatment (LPET)

+ Partner with the Investigator Engagement organization to achieve regional enrollment goals.

+ Manage relationships and serve as a single point of contact and central owner for trial communication, to and from the Clinical Design and Delivery organization, all cross functional team members, and Third-Party Organization (TPOs).

+ Apply problem-solving skills to daily issues with cross-functional study team (including with vendors, affiliates/regions, global team members and other business partners).

+ Identify and assist in developing continuous improvement activities based on important trends such as industry, regulatory, new technology, etc.

+ Manage TPO qualification process, selection, and oversight.

+ Single point of accountability for the Trial Master File, working closely with functional record owners to ensure the file is current and inspection ready at all times.

+ Network and leverage expertise to anticipate trial and regional issues, identify areas of process breakdown, assess situations and propose proactive approaches that reduce and/or mitigate risks that impact ability to deliver the clinical trial.

+ Demonstrate ability to lead and influence in the midst of ambiguity.

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* Your Profile:

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* + Bachelors or University degree (scientific or health-related field preferred) and 3 years clinical research experience or relevant clinical trial experience in a scientific or health-related field; or an advanced degree.

** 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…