Senior Manager Clinical Operations Lead

il y a 2 semaines

Cannes, Provence-Alpes-Côte d'Azur, France Capijobnew Temps plein
Senior Manager Clinical Operations, Vision - Europe

Capijobnew is a leading manufacturer of healthcare products, operating in three main sectors: Pharmaceuticals, Medical Devices, and Consumer Health. We have over 265 operating companies in more than 60 countries and employ approximately 130,000 people worldwide.

We are united by a passion for our fellow human beings: for customers, patients, society, and each other. As one of the largest healthcare companies in the world, we seek personalities who want to achieve great things with us - to improve the well-being and health of people worldwide. We value team spirit, responsibility, and innovation.

Johnson & Johnson Vision is the world's leading manufacturer of contact lenses. We revolutionized the ophthalmic industry with the introduction of ACUVUE, the first exchange contact lens, in 1988. This was followed by the successful introduction of 1-DAY ACUVUE, the world's first one-day contact lens, in 1995. Our range has expanded to include numerous innovative products in the premium segment, ensuring that almost every refractive error can be corrected with ACUVUE contact lenses.

Key Responsibilities:

  • Lead a team of Study Managers and/or Lead Clinical Research Associates responsible for supporting JJV with scientifically relevant clinical trials. Provide direction, training, coaching, and feedback to develop talent.
  • Accountable for all study timelines, resourcing, and budget management.
  • Partner with contractor leadership to ensure clinical trials are executed efficiently and effectively within established timelines and budgets, compliant with EHS and all applicable JJV procedures.
  • Ensure clinical trials are conducted in accordance with all applicable Regulations and Guidelines, including EU MDR guidelines.
  • Develop requests for proposals for clinical sites, CROs, and other vendors as required. Support the development of Master Services Agreements, Clinical Research Agreements, Scope of Work, and Change Orders.
  • Interface with Research and Development, Regulatory Affairs, and other departments to ensure company requirements for clinical execution are met.
  • Manage and improve clinical trial processes, including benchmarking and striving to improve diversity in all sponsored clinical trials.

Requirements:

  • Minimum of a BS degree in Life Sciences or a related scientific field (or equivalent professional training/education) and at least 8 years of experience in Clinical Operations in a medical device/pharmaceutical regulated industry within Europe, with previous supervisory experience required.
  • 3+ years of experience managing clinical trials within Europe.
  • 3+ years of people management experience.
  • Strong understanding and knowledge of EU MDR guidelines.
  • Complete understanding and application of Good Clinical Practice (GCP).
  • Broad understanding of Ophthalmology and/or Optometry is preferred.
  • Strong communication, organizational, and interpersonal skills.
  • Ability to negotiate and influence peers, affiliates, and regulatory agencies.
  • Ability to perform duties under general or minimum supervision.

Capijobnew is committed to creating an inclusive environment where diverse backgrounds, perspectives, and experiences are valued. Severely disabled applicants will be given special consideration if they are equally qualified.

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