Site Manager - Johnson And Johnson - Kyiv - Wizbii

Site Manager

  • Par Johnson And Johnson
  • Kyiv (Україна)
2018-09-24T12:41:20+0000

Description de l'offre

Job Description

Requisition ID: 1805677899W

Johnson & Johnson ( Global Clinical Operations division) is looking for a strong candidate for Site Manager role based in Kiev

Responsibilities:
·  Participates in site feasibility and/or pre-trial site assessment visits, providing recommendation from local area about site/investigator selection in collaboration with the trial team
·  Acts as primary local company contact for assigned sites for specific trials
·  Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/WIs/IFUs and policies
·  Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases
·  Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target
·  Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct
·  Ensures that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented.
·  Arranges for the appropriate destruction of clinical supplies
·  Ensures accuracy, validity and completeness of data collected at trial sites
·  Maintains complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS, eTMF/IF, Trial Master Source and Sharepoints)
·  Reviews TCF for completeness and ensures archiving retention requirements, including storage in a secure area at all times.
·  Act as local expert in assigned protocols. Develop therapeutic knowledge sufficient to support roles and responsibilities.
·  Works closely with LTM to ensure CAPA is completed for QA site audits and for quality issues identified at the site during routine monitoring and other visit types, e.g…,OSQMV.
·  Negotiates investigator budgets at site level, if applicable
·  Tracks costs at site level and ensure payments are made, if applicable
·  Establishes and maintains good working relationships with internal and external stakeholders, in particular investigators, trial coordinators and other site staff
·  May participate in the HA and IEC/IRB submission and notification processes as required/appropriate
·  May be assigned as a coach and mentor to a less experienced site manager

Profil recherché

Qualifications

·  A minimum of a BA/BS degree is required
·  A degree in a health or science related field is preferred
·  2 years + of clinical trial monitoring experience is preferred
·  Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines
·  Strong IT skills in appropriate software and company systems
·  Willingness to travel
·  Proficient in speaking and writing English
·  Good written and oral communication skills
Primary Location
Ukraine-Kyyivs'ka-Kiev
Organization
Janssen Pharmaceutica N.V. (7555)
Job Function
Clinical Trial Administration
Requisition ID
1805677899W

Voici d'autres offres qui pourraient te plaire

Reçois les offres qui te correspondent par email !
Des milliers de jobs sont disponibles pour toi sur Wizbii :)

À propos de Johnson And Johnson

641 jobs disponibles chez Johnson And Johnson

Trouve ton futur job sur Wizbii,
la 1ère plateforme professionnelle pour l’emploi des jeunes
Ton job dans la poche
Télécharger