Business Support Manager


At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen is a pharmaceutical company of Johnson & Johnson. www.janssen.com Business Support Manager based in Warsaw Global Clinical Operations (GCO) Poland is the part of Janssen organization specialized in conducting clinical trials to evaluate the efficacy and safety on new therapeutic solutions. Business Support Manager (BSM) is accountable for the successful country execution of activities supporting Therapeutic Area teams in study conduct, including regulatory submission, local vendor management, site/investigators contracting, study budget and payments processing as well as administrative support to LTMs/SMs. Main Activities on Business Support Manager position:
  • Providing leadership and meaningful management to GCO Poland Business Support staff
  • Ensuring study level administrative support to LTMs/SMs
  • Providing oversight of submission process and overall communication with Health Authorities / Independent Ethics Committees
  • Ensuring cross-study coordination and oversight of study start-up activities
  • Providing oversight of business processes and tools supporting clinical operations, e.g. V-TMF or oneCTMS
  • Providing oversight of external service providers, e.g. local drug depot, printing, medical translation and external legal counsel
  • Shaping effective collaboration within GCO and with Local Operating Company, i.e. Regulatory, Legal, Clinical Supplies Unit (CSU), Quality and Compliance (QC) and external vendor groups

Qualifications
  • Experience in clinical trials management and/or support (min. 5 years)
  • Experience in people management (preferable)
  • Sound understanding of drug development process including ICH/GCP and local regulatory requirements
  • Ability to work under time pressure and prioritize accordingly
  • Ability to negotiate over conflicting issues and develop win-win outcomes
  • Excellent communication, networking and interpersonal skills
  • Process thinking with ability to identify gaps and propose solutions
  • Proficiency in speaking and writing English

We offer:

  • An opportunity to be part of a global market leader
  • A dynamic and inspiring working environment
  • Many opportunities to work on challenging projects and assignments
  • Possibilities for further personal as well as professional development
  • Motivating financial remuneration
  • Many employee benefits such as life and pension insurance, 5 weeks of holidays etc.

Primary Location
Poland-Mazowieckie-Warsaw
Organization
Janssen-Cilag Polska Sp. z o.o. (7824)
Job Function
Clinical Trial Administration
Requisition ID
1805662241W