Note: The job is a remote job and is open to candidates in USA. ICON plc is a healthcare intelligence and clinical research organization. The Clinical Development Trial Lead - Adjudication leads cross-functional clinical study teams in developing and executing local, regional, and global clinical trials, ensuring delivery with quality, on time, and within scope and budget. The role coordinates trial operations, enrollment, risk mitigation, budgets, vendors, communications, and Trial Master File readiness.
Responsibilities
- 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
Skills
- 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
Benefits
- 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.
Company Overview
Company H1B Sponsorship