ICON plc

Manager

ICON plc

full-time

Posted on:

Location Type: Hybrid

Location: Raleigh • North Carolina • United States

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Tech Stack

Google Cloud Platform

About the role

  • The Manager, IDEA is primarily responsible for data monitoring committee and endpoint adjudication projects and project team oversight.
  • This position oversees multiple projects and is responsible for establishing strong positive working relationships and processes with clients in order to secure future business opportunities.
  • This position oversees project staff resources and study personnel training.
  • This position serves as a direct line manager for Project Assistants, Clinical Reviewers, and Project Managers.
  • Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
  • As a Manager, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
  • Travel (approximately 30%) domestic and/or international.
  • Provides line management to department staff consisting of Project Managers, Clinical Reviewers, and Project Assistants.
  • Keeps Director and/or Senior Director apprised of any potential/actual study or staffing issues and provides solutions for the same.
  • Coordinates and implements department training and identifies training needs.
  • Provides data monitoring committee and event adjudication training to other departments as requested.
  • Ensures staff training records are in compliance.
  • Serves as a mentor and role model for all team members.
  • Provides support to Project Manager in the development of project processes, workflows, and training materials as needed.
  • Provides support to Project Manager regarding their collaboration with internal and external study team members as needed.
  • Establishes and maintains strong positive working relationship with clients to improve process efficiencies across protocols, and increase future business opportunities.
  • Provides oversight, leadership, and structure for customer service interface from proposal generation, bid defense, service delivery, to trial closeout.
  • Provide project process and financial oversight and support to project team members.
  • Evaluates and secures project departmental staff resources.
  • Serves as subject matter expert to support team members in identifying and overcoming project related challenges.
  • Develops and implements department initiatives to improve client satisfaction, process efficiency, cost savings, quality improvement, and staff satisfaction.
  • Maintains quality metrics and attends project quality review meetings as required.
  • Attends bid defense meetings and provides input on new business proposals.
  • Ensures audit readiness and participates in internal, client, vendor, and regulatory audits.
  • Participates in the development and revision of departmental standard operating procedures and work instructions.

Requirements

  • Prior relevant clinical trial experience
  • Basic knowledge of applicable global, regional, local clinical research regulatory requirements; ie Good Clinical Practice (GCP) and International Conference of Harmonization (ICH) guidelines, standard operating procedures (SOPs), or the ability and willingness to gain this knowledge.
  • Previous clinical trial and managerial experience required
  • Previous Project Management experience required
  • Demonstration of professional demeanor, judgment and discernment in interactions with Clients, colleagues, and other ICON staff
  • Ability to interact effectively and professionally with various levels of staff for both internal and external departments, vendors, or Sponsors
  • Excellent computer skills (Microsoft Word, Excel, PowerPoint, Outlook).
  • Experience working with electronic data capture and transfer methods
  • Knowledge of medical terminology
  • Excellent communication, documentation, and presentation skills
  • Excellent organizational, time management and problem-solving skills
  • Strong sense of responsibility and dedication
  • Attentiveness to detail and accuracy; ability to maintain quality standards
  • Ability to follow instructions/guidelines, utilize initiative and work independently
  • Proven ability to multi-task, manage competing priorities and timelines
  • Due to the nature of this position it may be required for the employee to travel. Therefore, dependent on the employees location, the employee may be required to possess a valid Drivers license.
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 trial experienceproject managementdata monitoringendpoint adjudicationelectronic data captureGood Clinical Practice (GCP)International Conference of Harmonization (ICH)standard operating procedures (SOPs)quality metricsprocess improvement
Soft Skills
leadershipcommunicationorganizational skillsproblem-solvingattention to detailtime managementprofessional demeanorjudgmentinterpersonal skillsmentoring