J&J Family of Companies Senior Site Manager in Kiev, Ukraine
The responsibilities include site recruitment, patient recruitment and retention planning, site initiation, monitoring and close-out. The Senior Clinical Research Associate ensures study related activities in compliance with all GCO SOPs, policies and regulatory requirements from start-up through data-base lock. He/she also partners with the CTA, LTM and GTM to ensure overall site management while performing trial related activities for assigned protocols. He/she also serves as primary point of contact and liaison between investigational site staff and GCO study team once site is initiated. Additionally, he/she also represents functional area in divisional/company-wide process initiatives.
The principal responsibilities include the following:
- He/she participates in Site/Investigator selection process by providing recommendations from local area. He/she also assesses site experience, facility, and EDC capabilities to perform study activities (e.g., EDC, imaging).
Additionally he/she is 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.
He/she ensures Visit Reports are written and submitted via eTMF within 5 working days. He/she also ensures site staff resolve data queries, and works with sites to ensure data timelines are met.
He/she maintains accurate and timely data in systems utilized for clinical trial management and also updates site payments in CTMS.
He/she ensures, in collaboration with LTM, the timely and accurate data collection, documentation and communication of site/study progress and issues.
Additionally, he/she also plans, conducts and documents site staff training and monitors site performance. Additionally, he/she also updates training matrix in SharePoint as necessary and ensures all site personnel training documentation is on file at the site and in the Investigator File. He/she contributes to site level recruitment strategy and contingency plan in partnership with other functional areas to achieve clinical research targets.
He/she also presents/participates in Investigator Meetings as needed and also monitors expiry date of Investigational Product and ensures study supply strategy is adequate.
He/she works with LTM to ensure CAPA is completed for QA site audits and also attends regularly scheduled team meetings and trainings.
A University degree is required. Degree in medicine is preferred. A minimum of two years pharmaceutical experience is required as well as clinical monitoring experience. Should have solid understanding of the drug development process including GCP and applicable Ukrainian Regulations. Solid communication and computer skills required. A valid Driver's License is preferred. Travel approximately 60% is required.
Representative Office of Janssen Pharmaceutica NV (7557)
Clinical Trial Administration