Johnson & Johnson Careers

Senior Associate, Global Clinical Operations

Warsaw, Poland
Clinical Trial Administration


Job Description

Requisition ID: 1905760061W

The Johnson & Johnson Group of Consumer Companies is recognized as a world leader in providing OTC medicines. The breadth and depth of our product portfolio is truly impressive and constantly expanding as we strive to bring science to the art of healthy livingTM. Each day, millions of people of all ages in homes around the world use products from one or more of our consumer healthcare companies. These products hold allergy symptoms in check, help heal wounds, reduce fevers, and tame the urge to smoke. Each one of our consumer health businesses embraces cutting-edge science to create products that are doctor-recommended, helping you and your family to be well and stay well. As a result, our consumer companies produce many of the world’s most trusted brands, taking health and well-being to the next level.

 

Senior Associate, Global Clinical Operations

Location: Warsaw, Poland

Contract: full time, permanent contract

 

With minimal direction and supervision from senior colleagues: initiate and manage operational aspects of global company sponsored clinical trials in accordance with Johnson & Johnson global standards/guidelines and international regulations (GCP/ICH). Role is including but not limited to general study oversight, tracking budget and timelines, acting as sponsor liaison with study sites and external service providers (ESPs), and /or support senior colleagues with operational tasks needed in management of global clinical trials.

 
The responsibilities & the impact YOU will have:
  • Ensure preparation of / prepare study-specific documents.
  • Ensure review of case report forms (CRFs), CRF completion guidelines, data management plans, statistical analysis plans, inspection readiness plans, and patient-reported outcome scales and questionnaires.
  • Ensure preparation of Clinical Trial Agreements/site contracts, Transfer of Obligations & Compliance actions.
  • Ensure Sponsor oversight of studies and performance of ESPs on a continual basis
  • Ensure that clinical trials are conducted in compliance with the study protocol and all contractual agreements.
  • Ensure maintenance of Trial Master Files.
  • Oversee and track subject recruitment and retention.
  • Prepare posting of clinical studies on public registries.

Qualifications

We’d love to hear from YOU, if you have:

  • Education: Minimum of a Bachelor of Science degree in the field of Science (Nursing, Pharmacy or equivalent)
  • Experience: Minimum 2-4 years of pharmaceutical industry experience within international clinical operations management (Clinical Research Manager or similar)
  • Advanced knowledge of written and spoken English
  • Structured and well-organized way of work with attention to detail
  • Must have good communication skills (both verbal and written) and be able to work effectively in cross-functional teams both internally and externally to the organization
  • Experience writing and maintaining SOPs
  • Demonstrated working knowledge of the principles of drug and device development
  • Proficiency in GCP and ICH regulations
This is what awaits YOU at J&J:
  • A unique opportunity to become part of a global consumer healthcare market leader
  • A versatile and fulfilling role in a dynamic and international corporation
  • Work in a supportive and highly professional team
  • Further opportunities for professional development and career growth
  • Motivating financial remuneration & numerous employee benefits

Primary Location
Poland-Mazowieckie-Warsaw-
Organization
Johnson & Johnson (Poland) Sp. z.o.o. (7815)
Job Function
Clinical Trial Administration
Requisition ID
1905760061W