Sr. Clinical Operations Lead

Clinical Operations Lead - Early Development Oncology 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

• Participate as a member of a working group and perform special projects, as assigned, to improve the efficiency, effective and quality of the functioning of the Development Operations department.
• Act as preliminary liaison for study sites to convey study information, answer questions and in accordance with the escalation pathway.
• Develop relationships with investigational sites, HCPs, and institutions to enhance conduct of the trial.
• Monitor study-specific timelines and key deliverables; focus on management of all relevant external vendors (e.g., Monitoring, Sample management, IVRS, Laboratory, etc). Participate as a member of the multi-disciplinary trial(s) team.
• Participate in coordinating efforts with internal Pharmacovigilance, and safety group as needed.
• Participate in data review and discrepancy resolution as needed.
• Assist in the development of the IP and co-medication strategy (quantities, labels, depots, tracking, etc.) working closely with other departments.
• Plan and organize meetings with team support (e.g., investigator/coordinator meetings, DMC, SMC, safety call, etc.) as appropriate.
• Assist in the development and management of study timelines and priorities, including recruitment tools/strategy.
• Coordinate and monitor activities at investigational sites; review monitoring trip reports and support the US monitoring organization as appropriate.
• Participate in the feasibility and evaluation of investigative sites as needed, working closing with the Clinical Trial Logistics group.
• Create Master ICF template and review/approve site changes (in consultation with legal, safety when warranted). Update template for new risks and new amendments information.
• Assists in the review, development and writing of study documents and manuals, including but not limited to study manuals, treatment guidelines, patient access forms, laboratory or biomarker plans, and other supporting documents.

Minimum Requirements

• BS/BA degree or a relevant degree with strong emphasis on science, or equivalent experience
• Minimum of five years of relevant experience in the biopharmaceutical industry or other relevant clinical research experience, with a focus on skills and competencies.
• Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health
• Prior experience in assisting the conduct and management of multinational clinical trials is preferred.
• Ability to effectively manage multiple priorities across several protocols and therapeutic areas simultaneously.
• Experience in oncology studies required (phase I 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, 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 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 Apply tot his job Apply To this Job