ICON plc

Senior Line Manager, Clinical Operations

ICON plc

full-time

Posted on:

Location Type: Hybrid

Location: Reading • 🇬🇧 United Kingdom

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Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • Operations leadership
  • Primary client point of contact for the partnership
  • Leads the implementation of the transition to the new client model, and ongoing change management as the model matures
  • Leads operational risk management and mitigation regarding services contracted to ICON
  • Maintains accountability and oversight of the delivery of the service
  • Serve as the escalation point for all issues arising from day-to-day activities of the CRO employees which cannot be resolved through the CRO Dedicated Line Managers or Lead CRA.
  • Supports governance meeting preparation, presentation, minutes, and action items.
  • Resource Planning & Allocation: Manage and allocate resources effectively across projects to optimize efficiency and productivity.
  • Identify resource gaps and collaborate with leadership to address staffing needs.
  • Develop and implement strategies to maximize resource utilization.
  • Enable efficient resource forecasting in collaboration with the client'.
  • Continuously improve FTE demand forecast accuracy by assessing forecast data against actuals and other availability operational data.
  • Manage evolution of forecasting and reports to meet changing customer needs, e.g. scenario modeling.
  • Manage staffing logistics for projects, ensuring staffing requests/demands are filled in an efficient, and timely
  • Proactively identify risks and facilitate resolution of complex study problems and issues.
  • Workforce & Capacity Management: Analyze workload distribution and ensure balanced work assignments.
  • Forecast resource requirements based on project demands and client input
  • Manage the ICON time codes on which users book hours in the time tracking system, and ensure system compliance
  • Ensure Client resource systems are up to date at all times.
  • Conduct regular QC of Client resource systems.
  • Act as Subject Matter Expert to team regarding client onboarding and training.
  • Oversee training compliance of assigned resources (with support of operational leadership)
  • Work in conjunction with Line Managers to ensure that assignments are correct and checked against current demand.
  • Ensure updates and notifications from the RRF have been completed and are correct.
  • Ensure clear communication of assignments to allocate staff and manage transitions in the appropriate timeframe.
  • Liaise with client and ICON Global Operational Lead to agree staffing and FTE/$ budget requirements,
  • Liaise with client and ICON Global Operational Lead and ICON commercial and legal leads to maintain and amend SOW contractual coverage for agreed resourcing demands
  • Maintain change order documentation/process and regular budget true ups and SOW updates
  • Act as the Resource Lead point of contact for Astra Zeneca regarding resource requirements, assignments, budget and contractual coverage.
  • Schedule and chair regular resource calls with Line Managers as required, providing notes/minutes to support resourcing decisions.
  • Data Reliability & Integrity: Ensure resourcing / assignment data reliability and integrity.
  • Support data quality improvement initiatives as needed.

Requirements

  • 3+ years of relevant professional experience in Development operations, business analytics, performance/resource management, data science, project management.
  • Professional experience in clinical development or biopharma R&D preferred.
  • Previous biopharmaceutical clinical research experience (clinical research experience obtained working on industry-sponsored or industry-partnered clinical trials, or working on clinical trials at a biotech, pharmaceutical, or CRO company).
  • Experience leading the Clinical Operations teams (preferred)
  • Experience of resource management in a similar setting (preferred)
  • Line Management experience (preferred)
  • Understanding of the drug development process.
  • Experience interacting with external/internal stakeholders.
  • Ability to communicate directly with the client, including developing the material for and leading client meetings.
  • Advanced computer skills, including word processing, presentation, and spreadsheet applications.
  • Knowledge of Good Clinical Practices (GCP), FDA regulations, and applicable international regulatory requirements.
  • Excellent analytical and problem-solving skills, including analysis and presentation of operational status data.
  • Strong interpersonal communication and relationship management skills, High attention to detail, organizational skills, and result orientation.
  • Ability to work effectively cross-culturally and in a virtual environment.
  • Policy, process, and procedural conformance.
  • Fluency in English.
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
resource managementdata analysisproject managementperformance managementclinical developmentbiopharma R&DGood Clinical Practices (GCP)FDA regulationsdata quality improvementforecasting
Soft skills
interpersonal communicationrelationship managementorganizational skillsproblem-solvingattention to detailresult orientationcross-cultural communicationchange managementleadershipclient communication