Overview

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence. We are seeking a Senior Manager, Clinical Operations to join our diverse and dynamic team and function as the Global Clinical Operations Lead for an allocated program of FSP work. This is a remote-based position available in any EMEA location with good transport links.

Responsibilities

• Operations leadership
• Primary client point of contact for the partnership
• Lead the implementation of the transition to the new client model, and ongoing change management as the model matures
• Lead operational risk management and mitigation regarding services contracted to ICON
• Maintain accountability and oversight of the delivery of the service
• Serve as the escalation point for issues arising from day-to-day activities of the CRO employees which cannot be resolved through the CRO Dedicated Line Managers or Lead CRA
• Support 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 efficiently 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 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)
• Coordinate with Line Managers to ensure assignments are correct and checked against current demand
• Ensure updates and notifications from the RRF are completed and correct
• Communicate assignments clearly 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

Your Profile

Experience, Skills, Knowledge Requirements

• Work Experience:
• 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)

• Knowledge & Competencies:
• 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
• Education: BA/BS/BSc in related discipline, preferably in life science, or high school diploma/local equivalent with proven clinical experience

Remote based position available in any EMEA location with good transport links

What ICON Can Offer You

Our success depends on the quality of our people. ICON offers a range of benefits designed to be competitive within each country and focused on well-being and work-life balance opportunities for you and your family. Benefits include a variety of entitlements such as annual leave, health insurance offerings, retirement planning, LifeWorks EAP, life assurance, and other country-specific options. ICON is committed to providing an inclusive and accessible environment for all candidates and to equal opportunity in employment. If you need a reasonable accommodation for any part of the application process, please let us know.

Visit our careers site to read more about the benefits ICON offers.

If you are a current ICON Employee, please click here to apply.

Seniority level: Mid-Senior level

Employment type: Full-time

Job function: Management and Manufacturing

Industries: Pharmaceutical Manufacturing

Locations: Reading, England, United Kingdom (Remote)

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.