Assoc Mgr/ Mgr, Clinical Operations - FSP Lilly (Mexico)
Mexico City, Mexico
hace 2 días

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients.

Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

Currently we are hiring in FSP Lilly Mexico a Manager, Clinical Operations to work with a team of Clinical Research Associates / Coordinating CRAs.

In this crucial role within IQVIA you will lead and motivate a team of CRA staff in order to achieve patient recruitment targets to high quality standards at sites.

Furthermore, you will drive and manage key strategic site relationships to build capability and a robust quality management to achieve customer and investigator 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 the Clinical Lead / Project Lead to ensure that resource needs and site requirements are met.

  • Drive and manage key strategic site relationships in order to build capability, drive productivity and robust quality management in line with site strategy.
  • Be an advocate for these sites within IQVIA.

  • 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 any 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
  • Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work;
  • 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.

    You should have :

  • Bachelor's or higher level degree in a health care or other scientific discipline or educational equivalent; 7 yrs of clinical trials experience, preferable including 3 years' experience in a leadership capacity;
  • or equivalent combination of education, training and experience

  • 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
  • Fluent English language skills, written and spoken
  • 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
  • Flexibility for travelling with CRAs or to manage strategic site relationships
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