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1. Position Title : Sr. Site Manager
2. Sector : Janssen
3. Location : Taipei, Taiwan
Key Roles & 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.
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 a 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 .
Job Requirements / Qualifications
A minimum of a BA / BS degree is required. A degree in a health or science related field is preferred. A minimum of 3 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.