Johnson & Johnson Careers

senior site manager

Beijing, China; Beijing, China
Clinical Trial Administration


Job Description

Requisition ID: 1805679228W

  • 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.
  • Attends/participates in investigator meetings as needed.
  • 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 site staff complete the data entry and resolve queries within expected timelines.
  • Ensures accuracy, validity and completeness of data collected at trial sites.
  • Ensures that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents.
  • 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.
  • Fully documents trial related activities in particular monitoring. Writes visit reports and uploads into eTMF within 5 working days for review and approval. Complete follow-up letter to communicate relevant information and required corrective action to the investigator and his/her team with 15 working days. Promptly communicates relevant status information and issues to appropriate stakeholders.
  • Follows the corresponding Monitoring Guidelines for each assigned trial.
  • Reviews TCF for completeness and ensures archiving retention requirements, including storage in a secure area at all times.
  • Collaborates with LTM for documenting and communicating site/study progress and issues to trial central team.
  • Attends regularly scheduled team meetings and trainings.
  • Complies with relevant training requirements. 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.
  • Prepares trial sites for close out, conduct final close out visit.
  • 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.
  • Act as an point of contact in site management practices.
  • May be assigned as a coach and mentor to a less experienced site manager.
  • May contribute to process improvement and training.
  • Leads and/or participates in special initiatives as assigned.
  • May assume additional responsibilities or special initiatives such as “Champion” or Therapeutic Area Expert”.


Qualifications
  • A minimum of a BA/BS degree is required. A degree in a health or science related field is preferred. A minimum of 2 years of clinical trial monitoring experience is preferred, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
  • Specific therapeutic area experience may be required depending on the position.
  • 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 with occasional overnight stay away from home. 
  • Proficient in speaking and writing the country language and English. Good written and oral communication skills.

Primary Location
China-Beijing-Beijing
Other Locations
China-Beijing-Beijing
Organization
J&J (China) Investments Ltd A- Beijing Branch (7075)
Job Function
Clinical Trial Administration
Requisition ID
1805679228W