Apply on Employer Site

ICON Strategic Solutions · 3 days ago

Sr Study Manager - Oncology - Home Based (US or Canada)

United States

Full-time

Remote

Senior Level

7+ years exp

ICON plc is a world-leading healthcare intelligence and clinical research organization. They are seeking a Senior Study Manager to lead and support clinical trials, ensuring operational execution and managing trial deliverables. The role involves overseeing clinical trial activities, vendor interactions, and maintaining project schedules while ensuring quality control and compliance.

Pharmaceuticals

Responsibilities

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

Qualification

Clinical research experienceOncology experienceProject managementMS ProjectExcel skillsGlobal experienceLeadership responsibilitiesDatabase managementCommunication skills

Required

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

Minimum 2 years pharmaceutical experience with demonstrated leadership responsibilities required

Proven ability to meet aggressive timelines

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

Preferred

MS Project experience preferred

Gyn indication highly preferred

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.