Clinical Project Manager managing Class II and Class III medical device clinical trials for Cochlear. Leading teams and ensuring compliance with regulatory standards in a hybrid work environment.
About the role
- Senior Manager overseeing global clinical operations at ICON, leading resource allocation and partner relationships. Managing operational risks and service delivery across projects with a focus on efficiency.
Responsibilities
- 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.
Job title
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