Currently we are hiring in FSP Argentina a Manager, Clinical Operations to work with a team of CRAs and / or Coordinating CRAs.
In this crucial role within IQVIA you will lead and motivate a team of CRA staff in order to achieve client expectations and KPIs, while maintaining high quality standards at sites.
Furthermore, you will drive and manage key strategic client relationship to build an environment of collaboration and trust and work diligently to achieve customer satisfaction.
While projects vary, your typical responsibilities might include :
Formulate strategies and action plans to maximize delivery of a high quality team / department monitoring service, ensuring achievement of individual / team / department targets, aligning with company strategies.
Ensure sufficient level and profile of resource is recruited for each project. Maintain systems compliance and oversight for effective project delivery.
Collaborate with internal stakeholders to ensure that resource needs are met.
Manage, develop, coach, and motivate CRAs to develop their skills to ensure that a high professional standard is achieved and project targets are met.
Be an advocate for individual career development.
Conduct Accompanied Site Visits (ASV’s) to develop CRA’s skills (e.g. patient recruitment). Support CRA’s on solving project specific issues across site portfolio.
Identify quality risks and issues and suggest appropriate corrective action plans to senior management to prevent or correct deficiencies in performance of employees.
Share IQVIA and customer key business drivers with all CRA staff. Drive decision making in line with these.
Attend customer meetings, maintain interactions with local sponsor affiliates.
Maximize profitability by ensuring project objectives and customer requirements are achieved.
Ensure that staff have the proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training plan and mentored training experiences.
Ensure timely and accurate reporting of required information on company systems.
Support continuous improvement of monitoring processes to deliver quality, consistency and efficiency in delivery.
Participate in the selection process for new staff by conducting candidate review and participating in the interviewing process.
Conduct on-boarding training for new staff in conjunction with Human Resources and Learning and Development training programs.
Project a professional impression of the Company and act in accordance with the relevant Pharmaceutical Industry’s Code of Practice
gathering feedback for appraising performance, guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems.
Approve actions on human resources matters in consultation with Human Resources and other relevant departments.
Work conditions : home based.
You should have :
7 yrs of clinical trials experience, preferable including 3 years' experience in a leadership capacity; or equivalent combination of education, training and experience
Would be a plus experience in clinical project management (as Clinical Lead, Global Trial Manager, Project Lead or similar).
Fluent English language skills, written and spoken
Flexibility for travelling with CRAs
Broad understanding of the health and research environment, patient pathways through health systems and operational processes at research sites.
Advanced knowledge and ability to apply GCP / ICH / applicable guidelines, solid understanding of new methodologies in research e.g. remote monitoring
Excellent / Proven management and communication skills (written and verbal), ability to present to senior management
Ability to translate company strategy into motivational local practices
Ability to coach / mentor and develop staff
Ability to lead, collaborate and build effective relationships (including cross-functionally) with co-workers, managers, sites and customers
Ability to plan and meet project objectives / conflicting priorities
Strong project management and change management skills
Excellent organizational and problem solving skills.
Internals NOTE :
It can be someone with no previous LM experience, but would be important to have previous leadership experience (as Project Lead CL / PL) and strong leadership competencies.