As an Associate Director, Regional Clinical Operations you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
What you will be doing:
The Associate Director, Regional Clinical Operations (RECO) (United States) responsibilities include leadership and local strategic planning and operational delivery of assigned clinical trials to support the Sponsors' pipeline, in accordance with the appropriate quality standards, including ICH/GCP/GPP standards, Sponsor SOPs, local operating guidelines and local requirements, as applicable. The RECO works locally toward Global Operational goals for recruitment and completion of R&D sponsor trials within timelines and budget.
- Accountable for oversight of all assigned studies within the country in accordance with the overall development plan and clinical operations plan and under the direction of the global team (Global Clinical Trial Manager), including adherence to quality, timelines and budget.
- Accountable for planning and executing assigned country study goals and commitments, and as needed, leading, organizing, and participating in regional and/or local meetings and training sessions to implement country-level recruitment plans.
- Develops, builds and maintains optimal relationships with key institutions within the country (i.e. Site Alliance Sites), working closely with the Medical Science Liaisons, Global Site Management and Central Services, and other departments as indicated according to the Site Engagement Strategy.
- Drive the identification and inclusion of sites that have access to and can enroll patients who are from groups that have been historically underrepresented in clinical trials (per FDA Guidance for Industry for Improving Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials).
- Oversees regional study feasibility, site monitoring performance, quality metrics and all relevant activities for assigned studies. Drives evidence-based site recommendations and selection.
- Provides support and training for sites to support diverse recruitment and retention, review, assist and optimize site-level diversity plans as needed, check and challenge progress and coordinate and align central efforts across Sponsor and CROs. Align local and central initiatives and advise and guide on effective community engagement activities.
- Conduct co-monitoring and site identification visits, as needed.
- Collaborates cross-functionally to build and maintain strong relationships and interaction at the country local level (i.e. Medical Science Liaisons, Medical Monitors, Clinical Scientists, etc.) that directly contribute to key study activities and milestones.
- Communicates regularly on country study (ies) status and escalates unresolved issues appropriately to the Regional Clinical Operations Head, North America, Clinical Operations Asset Lead, Clinical Operations Executive Therapeutic Head, and/or Global Study Team.
- Collaborates with the Global Study Team, and when necessary, develops and executes the local implementation of the risk management plans, identifying critical issues for the country and ensuring contingencies are established and captured in the study level risk management plan.
- For in-house studies, works with the Study Start-Up Team to ensure timely submission of all regulatory, IRB and administrative submissions and helps ensure their appropriate approval.
- Collaborates in local quality/compliance reviews, internal audits, and regulatory inspections, ensuring inspection readiness at all times and implementation of Corrective Action Plan for assigned studies.
- Ensures that clinical data from sites are of quality and delivered in accordance with established data entry and cleaning timelines and deliverables.
- Represents country and line reports and provides the Global Study Team with actionable country-specific feedback.
- Works closely with counterparts in the Regional Clinical Operations Organization to discuss and share country best practices, and contribute to process and initiatives that improve quality and effectiveness and that provide visibility to the Regional Clinical Operations organization.
- Ensures that the Sponsor Clinical Trial Management and various business intelligence and tracking systems are complete and up to date for assigned studies.
- Proactively incorporate learning and recommendation from study debriefs, best practices and lessons learned.
- Maintains oversight and ensures consistency across studies and alignment across CROs for outsourced studies.
- Makes an active contribution to therapeutic area strategy teams (i.e. Global Study Team, Asset Lead Meetings, etc) ensuring knowledge sharing of regional interest. Serves as an active contributor and rotating member on the Protocol Review Committee (PRC).
- Manages issues related to local invoices and provide oversight of any budget reconciliation, in collaboration with Global Clinical Study Manager and relevant departments.
- If appropriate, review CRO monitoring plans, training plans and relevant study plans for studies conducted in the region.
You are:
- Must be located in one of the following states: VA WV KY MI WI OH MO KS NE SD ND IN MI IL IA
- The position requires a minimum Bachelor’s degree with 5-7 years of experience in Clinical Trial Operations in pharmaceutical / biotechnology industry or Clinical Research Organization, or equivalent, including at least 3 years in a role of primary responsibility for clinical trial execution and management.
- Thorough understanding and experience in global clinical trials in a diverse range of patient populations with preferred experience in oncology.
- Demonstrated leadership and management skills.
- Goal oriented, self-starter with proven ability to work independently.
- Good knowledge and experience working with external specialist vendors.
- Excellent interpersonal, organizational, problem-solving, and written/verbal communication skills, confidence, and ability to work effectively with a wide variety of medical, research and administrative personnel.
- Able to proactively identify issues and provide potential solutions for resolution.
- Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines and to established quality standards.
- Proficient in Outlook/Word/Excel/PowerPoint.
- Must be able to travel (domestic and international) up to 30%.
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 maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. 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 through the form below.
https://careers.iconplc.com/reasonable-accommodations
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.
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