ICON plc

Senior Study Manager

ICON plc

full-time

Posted on:

Location Type: Remote

Location: Pennsylvania • United States

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Job Level

Senior

About the role

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

Requirements

  • 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
  • MS Project experience preferred
  • Excellent Excel and PP skills required
  • TA- ID/Vaccines experience required
  • Global experience required
  • Excellent oral (including presentation) and written communication, computer/database management, and project management skills required.
  • Home Based position in US or Canada
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, 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.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
clinical researchproject managementprotocol trainingrecruitment planningbudget managementrisk assessmentdata managementquality controltrial set-upeTMF
Soft Skills
leadershipcommunicationorganizational skillsproblem-solvingcollaborationpresentation skillstime managementattention to detailinterpersonal skillsadaptability