Manager, Clinical Operations

Há 7 dias

São José dos Campos, São Paulo, Brasil Johnson & Johnson Consumer Inc Tempo inteiro
Kenvue is currently recruiting for: Manager, Clinical Operations This position is based at São José dos Campos, Brazil.
Who We Are At Kenvue, we realize the extraordinary power of everyday care.

Built on over a century of heritage and rooted in science, we're the house of iconic brands - including NEUTROGENA, AVEENO, TYLENOL, LISTERINE, JOHNSON'S and BAND-AID that you already know and love.

Science is our passion; care is our talent.

Our global team is made by 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers.

With expertise and empathy, being a Kenvuer means to have the power to impact life of millions of people every day.

We put people first, care fiercely, earn trust with science and solve with courage - and have brilliant opportunities waiting for youJoin us in shaping our future-and yours.

What will you do The Clinical Operations Manager is responsible to manage a team of clinical study management Staff working in support of Clinical Studies to ensure projects are appropriately resourced, employees are trained, meeting project objectives and CGC Compliance.

The Clinical Operations Manager will collaborate with Key roles within the Clinical Operations global organization, as well as Study directors, Clinical IT and Bioresearch Quality & compliance (BRQC).Key Responsibilities * Oversee staff management in accordance with organizational policies and relevant regulations.

This includes responsibilities such as planning, delegating, and directing work, evaluating performance, and guiding professional development, as well as addressing employee relations issues and resolving problems.
  • Ensure that staff have the necessary materials, system access, and training to carry out their job responsibilities.
Provide supervision for the implementation of the training plan, SOP review, and training experiences as appropriate.
  • Contribute to the allocation of resources to clinical operations projects by assigning staff to clinical studies based on their skills and training.
  • Monitor the quality of clinical work performed by staff through regular review and evaluation.
  • Identify quality risks and issues and develop appropriate corrective action plans to prevent or address deficiencies in staff performance.
  • Ensure that staff meet defined workload and quality metrics by regularly reviewing and reporting findings as outlined by clinical.
Required Qualifications * Bachelor's Degree Degree in scientific discipline or health care preferred.
  • Prior clinical study management study experience including experience in a people/team management capacity (at least 2 years) or equivalent combination of education, training and experience.
  • In-depth knowledge of applicable global clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
  • In-depth knowledge of electronic trial master file (TMF) management and clinical trial management system (CTMS)
  • Good leadership skills.
  • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.
  • Advanced English is required (spoken and written).
  • Excellent organizational and problem-solving skills.
  • Effective time management skills and ability to manage competing priorities.
  • Ability to establish and maintain effective working relationships with coworkers, managers, in a global team, etc.
Desired Qualification * Demonstrated working knowledge of cosmetic and drug regulations.
  • Experience as a Clinical Study Manager in global drug clinical studies

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