Sr. Clinical Operations Lead

ICON plc • Raleigh, NC

3d

About The Position

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.

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

Nice To Haves

• 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)

Responsibilities

• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level