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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. Please visit www.janssen.com for more information.
Janssen, part of Johnson & Johnson Family of Companies, is now looking for an experienced Clinical Trials Site Manager:



Clinical Trials Site Manager

Location: Budapest
Full-time permanent contract


    Role Overview:
    The Clinical Trials Site Manager will be responsible for site recruitment, patient recruitment and retention planning, site initiation, monitoring and close-out. Ensure study related activities in compliance with all Clinical Operations, Standard Operating Procedures (SOPs), policies and regulatory requirements from Start-Up through Data-Base Lock. Partner with trial team members to ensure overall site management while performing trial related activities for assigned protocols. Serve as primary point of contact and liaison between investigational site staff and study team once site is initiated. Represent functional area(s) in divisional/company-wide process initiatives.

Key Responsibilities:

  • Participate in Site/Investigator feasibility, qualification and selection process by providing recommendations from local area.
  • Execute activities within start-up, site monitoring, site management and site/study close-out, according to internal SOPs and policies.
  • Write timely Visit Reports and submit via electronic Trial Master File (eTMF).
  • Ensure site staff resolve data queries, and works with sites to ensure data timelines are met.
  • Maintain accurate and timely data in systems utilized for clinical trial management (i.e. CTMS).
  • Ensure timely and accurate data collection, documentation and communication of site/study progress and issues.
  • Plan, conduct and document site staff training and monitors site performance.
  • Present/participate in Investigator Meetings as needed.
  • Monitor expiry date of Investigational Product and ensure study supply strategy is adequate.
  • Mentor new hires with supervision and serve as Lead SM for a specific trial as needed.
  • Review electronic Case Report Forms (eCRFs) and Completion Guidelines and participate in Electronic Data Capture (EDC) User Acceptance Testing (UAT) testing and special initiatives as needed.

Our Requirements:

  • A minimum of an Associate’s degree or completion of a Nursing Program (RN) is required. A Bachelor’s degree in a Health or Science discipline is preferred.
  • A minimum of 2 years of clinical trial monitoring experience is required.
  • Clinical research monitoring experience with any of the following Therapeutic Areas preferred: Oncology, Neuroscience, Immunology, Cardiovascular, Metabolics, Infectious Diseases, Vaccines.
  • Experience with Phase II and Phase III Clinical Trials required.
  • Strong knowledge of the drug development process, including Good Clinical Practices (GCPs) and FDA Code of Federal Regulations, is required.
  • Experience working with computer software applications is required.
  • Must have strong written and oral communication skills.
  • Willingness to travel 50%, approximately 2-3 days per week, with overnight stays (1-2 nights on average), is required.
  • A valid Driver's License.

Location:

Budapest

If you are interested in this role and you fulfill the requirements set above, do not hesitate to send us your CV and cover letter in English.

A hirdetés adatai:
  • Pozíció neve: Clinical Trials Site Manager
  • Rövid pozíció név: Site Manager
  • Hirdető cég: JNJ GLOBAL BUSINESS SERVICES S.R.O
  • Elsődleges kategória:
  • Terület: Budapest
  • Feladatok: Participate in Site/Investigator feasibility, qualification and selection process by providing recommendations from local area. Execute activities within start-up, site monitoring, site management and site/study close-out, according to internal SOPs and policies. Write timely Visit Reports and submit via electronic Trial Master File (eTMF). Ensure site staff resolve data queries, and works with sites to ensure data timelines are met. Maintain accurate and timely data in systems utilized for clinical trial management (i.e. CTMS). Ensure timely and accurate data collection, documentation and communication of site/study progress and issues. Plan, conduct and document site staff training and monitors site performance. Present/participate in Investigator Meetings as needed. Monitor expiry date of Investigational Product and ensure study supply strategy is adequate. Mentor new hires with supervision and serve as Lead SM for a specific trial as needed. Review electronic Case Report Forms (eCRFs) and Completion Guidelines and participate in Electronic Data Capture (EDC) User Acceptance Testing (UAT) testing and special initiatives as needed.
  • Elvárások: A minimum of an Associate’s degree or completion of a Nursing Program (RN) is required. A Bachelor’s degree in a Health or Science discipline is preferred. A minimum of 2 years of clinical trial monitoring experience is required. Clinical research monitoring experience with any of the following Therapeutic Areas preferred: Oncology, Neuroscience, Immunology, Cardiovascular, Metabolics, Infectious Diseases, Vaccines. Experience with Phase II and Phase III Clinical Trials required. Strong knowledge of the drug development process, including Good Clinical Practices (GCPs) and FDA Code of Federal Regulations, is required. Experience working with computer software applications is required. Must have strong written and oral communication skills. Willingness to travel 50%, approximately 2-3 days per week, with overnight stays (1-2 nights on average), is required. A valid Driver's License.
  • Elvárt végzettség: Főiskola
  • Elvárt nyelvismeret: Angol
  • Foglalkoztatás jellege: Teljes munkaidő
  • Szükséges tapasztalat: 1-3 év szakmai tapasztalat
  • Feladás dátuma: 2018-02-14
Állás, munka még: JNJ GLOBAL BUSINESS SERVICES S.R.O>