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ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
The Clinical Operations Manager will manage a local clinical team effectively, maximising resource use to deliver operational, quality, and fiscal targets whilst ensuring employee engagement, retention and growth. They will also be responsible for overseeing personnel, recruitment directives, meeting financial goals, and the overall operations of the clinical research site.
- Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance. Each employee is expected to ‘Own’ their role through values of integrity, partnership, collaboration and accountability and delivery.
- As a manager, you are 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.
- Understand and follow key principles with regard to resourcing, people leadership, training, functional delivery, quality and operational delivery measurements within the Clinical Operations group at regional/country level. This includes, but is not limited to, oversight of productivity and quality metrics, 1:1 discussions, team meetings, timely and objective performance reviews, recommendations for promotions, and CTMS updates.
- Ensure that staff assignments are adequate to meet corporate utilization and productivity targets.
- Ensure CRAs are meeting performance objectives for productivity and quality and take appropriate remedial actions and/or escalations as required.
- Ensure agreed corrective actions are implemented, and/or further training is received, as required.
- Provide feedback on the development and implementation of formal CRA training tools and presentations.
- Ensure that CVs for assigned CRAs are updated as required and skill set / experience is maintained in Planview.
- Ensure CTMS is current and updated.
- Understand the drivers of revenue and cost for the department, and contribute as required to budgeting discussions at each country level to ensure profitability.
- Serve as a contact for the country in regard to operational questions and escalations
- Understand ClinOps role in Inspection Readiness processes and educate team on its importance
- Understand ClinOps Key Performance metrics and how to ensure delivery against them.
- Understand department strategy and explain key elements to team
- Understand the drivers for a corporate culture of diversity and inclusion and incorporate them in your daily interactions with your team
- Interview, evaluate and select new associates, iHCRA and CRA hires.
- Ensure induction and orientation for newly hired CRAs and IHCRAs occurs.
- Set expectations and goals, give ongoing performance feedback, conduct timely and objective CRA and IHCRA performance reviews and appraisals using a metrics-driven, as well as 360 feedback, approach.
- Make recommendations for CRA and IHCRA promotions.
- Take formal actions to improve performance when needed.
- Establish a trusting and open two-way communication path with reporting lines to provide and receive timely and relevant updates.
- Partner with CRAs & IHCRAs on their development, identify opportunities to learn aligned to the individual career aspirations and help them get visibility within and outside the department Implement measures for retention of staff as needed.
Minimum 6 years Clinical Research experience that includes a minimum 4 years relevant experience as a Senior CRA or Principal CRA (in a Lead CRA role), or at least 2 years as a Project Manager, CRA Manager or equivalent job role
Knowledge of ICH- GCP guidelines and ability to review and evaluate medical data
Excellent management skills, developed with a collaborative approach to driving performance and success in a global environment
Direct experience managing Clinical Research Associates is preferred
**Benefits of Working in ICON**:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variab
