Senior Site Manager

Created by: Johnson & Johnson
Added: 29.06.2020

Advert description

Job Description

  • 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

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

Specific details

Type of Contract Full time
Preferred Education Bachelor's, Master's, Other
Level of Experience 2-5 years

Location

Ukraine, Europe
Kiev