Senior Study Manager – Oncology

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

May lead or support a study or studies, depending on size/complexity.

As lead, will be responsible for the following:

• Operational point of contact for trial execution and all trial deliverables.
• Manages all HQ Operational Activities, including: Establishes, leads and manages Clinical Trial Team (CTT) Supports clinical (drug/vaccine) supplies planning.
• Manages deployment and interactions with external vendors (e.g., IVRS, PRO).
• Initiates planning for Investigator meeting and protocol training.
• Plans and assesses protocol ancillary supplies.
• Completes trial set-up and maintains SPECTRUM.
• Schedules, prepares for, and leads the Recruitment Planning Meeting for the CTT.
• Initiates recruitment/retention planning & enrollment tracking.
• Responsible for tracking study related details (e.g., specimens, queries).
• Oversees protocol training activities including IMs and CRAs training meetings.
• Ensures appropriate postings to investigative site portals.
• Responsible for operational deliverables in preparation for site ready, country allocation and achievement of recruitment targets (with input from others).
• Point of escalation for study related operational issues.
• Responsible for operational details at Operational Reviews.
• Responsible for creating and maintaining project schedule and collaborating with Program Lead.
• Sets up and maintains Trial Master File (eTMF).
• Ensures alignment of budget with protocol needs.
• Responsible for executing protocol within the budget.
• Responsible for creating and maintaining ADI logs.
• Develops Site Monitoring Plan (SMP) with input from the monitoring excellence group.
• Develops study related manuals (e.g., administrative binder, lab manuals).
• Manages Emergency Unblinding (EUB) Call Center activities.
• Co-authors newsletters with CS.
• Approves contracts, invoice payments and change orders for vendors, as necessary.
• Responsible for end of study reconciliation (clinical & ancillary supplies).
• Oversees all HQ close-out tasks.
• Responsible for ongoing monitoring of trial activities, e.g. dashboards, tracking.
• Supports CS activities as needed to achieve CTT deliverables.
• Interface with External Data Coordination and Data Management.
• Responsible for quality control and inspection readiness at all times.
• Responsible for risk assessment, mitigation planning and execution.

Educational Requirements

• BS/BA/MS/PhD with 7+ yrs clinical research experience.

Minimum Years of Experience

• Minimum 2 years pharmaceutical experience with demonstrated leadership responsibilities required.
• Proven ability to meet aggressive timelines.
• MS Project experience preferred.
• Excellent Excel and PP skills required.
• TA- Oncology experience required.
• Global experience required .
• Excellent oral (including presentation) and written communication, computer/database management, and project management skills required.