Site Manager

Job description

Site Manager – Global Clinical Operations
PRINCIPAL 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

Desired profile

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 Russian and English
·  Good written and oral communication skills