Associate Director designing and improving third party management processes in Global Clinical Operations. Ensuring compliance and efficiency in clinical operations objectives.
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.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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