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Manager, Clinical Operations

  1. Hungary
2023-102574
  1. ICON Strategic Solutions
  2. Clinical Trial Management

About the role

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As a Clinical Operation Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence

Manage a local clinical team effectively, maximising resource use to deliver operational, quality, and fiscal targets whilst ensuring employee engagement, retention and growth.


Manage a local clinical team effectively, maximising resource use to deliver operational, quality, and fiscal targets whilst ensuring employee engagement, retention and growth.
Accellacare – Oversee 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.
Operational Excellence and Quality
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 key principles of client project management at the functional level - if required serve as the local clinical subject matter expert.
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
Talent, Leadership, Development & Culture
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. Support Talent Acquisition through own network.
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.
Act as a role model for the team - embrace ICON's Own It! Culture and always act as ICON's representative when you interact with your team
Partnership, Customers and Market Focus
Participate in country-wide business development activities, as appropriate.
Communicate in line with corporate communication channels on business critical issues (e.g. quality concerns and solutions, business growth opportunities).
Enhanced capabilities and expertise
Assist with review of current processes and implementation of agreed process improvements in collaboration with other regions and/or departments.
Understand the drivers of change and communicate effectively. Be a champion for change and innovation
Other
Travel (approximately 30%) domestic
Other duties as assigned.
• Dedicated People Leader for the local Clinical Operations team that includes CRAs, IHCRAs and CTAs as determined by the country team size and structure.
• Provide effective management support through your team to deliver a high performing culture including managing attrition, development and engagement of the operational group
• Carrying out all relevant People Leadership responsibilities including performance assessments, goal setting and development plans.
• Managing the local clinical operations team by empowering and coaching them to deliver their key objectives.

 


The role
• Provide direction and accountability for the operational teams and their delivery at regional and site level.
• Resourcing, line management, training, functional delivery and input on discussions around quality and operational delivery measurements within the Clinical Operations group
• Conduct regular discussions with direct reports and lead team meetings at regional and manager team level.
• Assist with training for CRA Managers and Associates as required.
• Contact for region in regard to operational questions and escalations.
• Work with Director/Senior Director and/or VP Clinical Operations to communicate all critical issues, business growth opportunities, developing key relationships as well as providing input regarding budgeting discussions to drive productivity and quality within the region.
• Drive overall delivery at site and regional level, through your operational team to drive execution of service, client satisfaction, quality and efficiencies.
• Represent Clinical Operations at Sponsor and internal audits.

What you need
• Bachelor’s degree
• 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



Why 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 variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

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.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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